TABLE OF CONTENTS

ABBREVIATIONS AND ACRONYMS...................................................... VI

ACKNOWLEDGEMENTS ........................................................................ 1

FOREWORD ......................................................................................... 1

LEGAL FRAMEWORK............................................................................ 3

DEFINITION OF KEY TERMS ............................................................. VII

CHAPTER ONE ................................. ERROR! BOOKMARK NOT DEFINED.

1.1 VISION....................................... ERROR! BOOKMARK NOT DEFINED.

1.2 MISSION .................................... ERROR! BOOKMARK NOT DEFINED.

1.3 CORE VALUES ........................... ERROR! BOOKMARK NOT DEFINED.

1.4 CORE FUNCTIONS ..................... ERROR! BOOKMARK NOT DEFINED.

CHAPTER TWO:................................ ERROR! BOOKMARK NOT DEFINED.

2.1 GENERAL CONSIDERATIONS ......................................................... 3

2.1.1 ORGANIZATION STRUCTURE AND MANAGEMENT ........................ 3

QUALITY MANAGEMENT SYSTEM ......................................................... 4

PERSONNEL ......................................................................................... 5

2.2 PREMISES, WAREHOUSING AND STORAGE.................................... 7

GENERAL REQUIREMENTS................................................................... 7
GENERAL STORAGE AREAS ......................................................................... 9
STORAGE CONDITIONS ............................................................................. 12
MONITORING OF STORAGE CONDITIONS ....................................................... 13
GOOD COLD CHAIN MANAGEMENT STORAGE.................................................. 14
GUIDELINES FOR GOOD RETAIL PRACTICE FOR
PHARMACEUTICALS ......................................................................... 15
2.2.1 NATURE AND SETUP OF PREMISES ........................................................... 16

iv
2.2.2 EQUIPMENT ........................................................................................ 18
2.2.3 REFERENCE MATERIALS ........................................................................ 19
2.2.4 RETAIL PHARMACY LICENCE ................................................................... 19
2.2.5 OPERATIONS ....................................................................................... 20
GUIDELINES FOR GOOD WHOLESALE PRACTICE FOR
PHARMACEUTICALS ......................................................................... 21
2.2.6 BUILDING AND GROUNDS ...................................................................... 21
2.2.7 FACILITIES ......................................................................................... 22
2.2.8 PERSONNEL ........................................................................................ 23
2.2.9 WHOLESALE PHARMACY LICENCE ............................................................ 24

3.0 HANDLING AND CONTROL OF MEDICAL PRODUCTS AND HEALTH

TECHNOLOGIES AND HEALTH TECHNOLOGIES ................................. 31

3.1 INWARD GOODS – FROM SUPPLIERS .......................................................... 31

3.2 OUTWARD GOODS – TO RETAIL PHARMACIES .............................................. 32
3.3 PORT HANDLING AND CUSTOMS CLEARANCE ............................................... 32
3.4 SPECIAL/ TEMPORARY STORAGE FACILITIES AT PORTS OF ENTRY .................... 33
3.5 HANDLING DURING IMPORTATION OF MEDICAL PRODUCTS AND HEALTH
TECHNOLOGIES ............................................................................................ 34
3.6 DAMAGED GOODS FROM STOCK ............................................................... 36
3.7 RETURNED GOODS ................................................................................ 36
3.7.3 INVENTORY MANAGEMENT..................................................................... 37
3.7.4 SUSPECTED SPURIOUS FALSIFIED AND FALSELY LABELLED PRODUCTS (SSFF) /
UNREGISTERED PRODUCTS ............................... ERROR! BOOKMARK NOT DEFINED.
3.7.5 COMPLAINTS ....................................................................................... 39
3.7.6 SELF-AUDIT ....................................................................................... 40
3.7.7 CORRECTIVE ACTION AND PREVENTIVE ACTIONS (CAPA) ............................ 41
3.7.7.1 CORRECTIVE ACTION ......................................................................... 41
3.7.7.2 PREVENTIVE ACTION .......................................................................... 41
3.8 VALIDATION.................................................................................... 42
3.9 CALIBRATION .................................................................................. 42
3.10 ELECTRONIC RECORDS .................................................................... 43
3.11 GOOD DISTRIBUTION PRACTICES CERTIFICATION .................................. 44

CONTROBUTORS/REVIEWERS ........................................................... 45

END OF DOCUMENT ........................................................................... 46

v
ABBREVIATIONS AND ACRONYMS
PPB- Pharmacy and Poisons Board
GUD- Guidelines
GDP- Good Distribution Practice
INSP- Inspectorate
ICRC- International Committee of the Red Cross
GSP- Good Storage Practices
SOP- Standard Operating Procedure
QMS- Quality Management System
QSE- Quality Safety and Efficacy
WHO- World Health Organization
OPV- Oral Polio Vaccine
POM- Prescription only Medicines
SSFFP’s- Suspected Spurious Falsified and Falsely Labelled Products
FEFO- First Expired First Out
FIFI- First in First out
SF - Substandard and Falsified Medical Products
CAPA- Corrective Action and Preventive Action

vi
GLOSSARY OF TERMS
Auditing: an independent and objective activity designed to add value and
improve an organization’s operations by helping the organization to accomplish
its objectives by using a systematic, disciplined approach to evaluate and
improve the effectiveness of risk management, control and governance
processes.
Authorised personnel: means a registered pharmacist, enrolled
pharmaceutical technologist or any other person approved by the Pharmacy
and Poisons Board.
Batch: A defined quantity of medical products and health technologies
processed in a single process or series of processes so that it is expected to be
homogeneous.
Calibration: The set of operations which establish, under specified
conditions, the relationship between values indicated by an instrument or
system for measuring, recording, and controlling, or the values represented
by a material measure, and the corresponding known values of a reference
standard. Limits for acceptance of the results of measuring should be
established. Including the maximum permissible error or uncertainty of
measurement;
Cold chain: All of the materials, equipment, processes and procedures used
to maintain all products (which require cold chain conditions) within the
required temperature range of 2 °C to 8 °C from the time of manufacture until
the products are administered to individuals. However, Storage conditions
should align with the manufacturer’s label specifications.

vii
Corrective action: Any action taken when the results of monitoring at the
critical control point indicates a loss of control; and the action taken in
response to audit findings;
Consignment: The quantity of medical products and health technologies
supplied at one time in response to a particular request or order. A
consignment may comprise one or more packages or containers and may
include medical products and health technologies belonging to more than one
batch.
Container: The material employed in the packaging of a pharmaceutical
product. Containers include primary, secondary and transportation
containers. Containers are referred to as primary if they are intended to be in
direct contact with the product. Secondary containers are not intended to be
in direct contact with the product.
Contamination: The undesired introduction of impurities of a chemical or
microbiological nature, or of foreign matter, into or on to a starting material,
intermediate or pharmaceutical product during handling, production,
sampling, packaging or repackaging, storage or transportation.
Cross-contamination: Contamination of a starting material, intermediate
product or finished pharmaceutical product with another starting material or
product during production, storage and transportation
Dangerous goods: materials or items with hazardous properties which, if not
properly controlled, present a potential hazard to human health and safety,
infrastructure and/ or their means of transport. These are available as
updated on: www.incb.org
Deviation: the failure to fulfil a specified requirement in terms of processes,
standards and regulations prescribed.
Distribution: The procuring, purchasing, holding, storing, selling, supplying,
importing, exporting, or movement of medical products and health
technologies, with the exception of the dispensing or providing medical
products and health technologies directly to a patient or his or her agent.
Expiry date: The date given on the individual container (usually on the label)
of a pharmaceutical product up to and including the date on which the product

viii
is expected to remain within specifications, if stored correctly. It is established
for each batch by adding the shelf-life to the date of manufacture.
Good Distribution Practices (GDP):That part of quality assurance that
ensures that the quality of a pharmaceutical product is maintained by means
of adequate control of the numerous activities which occur during the
distribution process as well as providing a tool to secure the distribution
system from counterfeits, unapproved, illegally imported, stolen, counterfeit,
substandard, adulterated, and/or misbranded medical products and health
technologies.
Good Storage Practices (GSP): That part of quality assurance that ensures
that the quality of medical products and health technologies is maintained by
means of adequate control throughout the storage thereof.
Importation: The act of bringing or causing any goods to be brought into a
customs territory (national territory, excluding any free zone).
Labelling: Process of identifying a pharmaceutical product including the
following information, as appropriate: name of the product; active
ingredient(s)
Lagged containers: An insulated container which meets the requirements
of transporting medical products and health technologies at the required
temperatures for the necessary duration of time
Pharmacy student: an individual who has been approved by the Pharmacy
and poisons board for training under the direct personal supervision of a
registered pharmacist or enrolled Pharmaceutical technologist
Pest: Refers to any objectionable animals or insects including, but not limited
to, bird, rodents, flies and larvae.
Preventive action: an action to eliminate the cause of a potential non-
conformity or another undesirable potential situation.
Medical Product:
Product recall: the removal of specific batch/batches of a pharmaceutical
product from the market for reasons relating to deficiencies in quality, safety
or efficacy
Quality system: An appropriate infrastructure, encompassing the
organizational structure, procedures, processes and resources, and

ix
systematic actions necessary to ensure adequate confidence that a product
(or services) will satisfy given requirements for quality
Quarantine: The status of medical products and health technologies isolated
physically or by other effective means while a decision is awaited on their
release, rejection or reprocessing.
Repackaging & relabelling: Any operations in which the original labelling
and or packaging materials more so, the primary and secondary packaging
are subsequently changed or replaced, leading to loss of product traceability
Sampling: Operations designed to obtain a representative portion of a
pharmaceutical product, based on an appropriate statistical procedure, for a
defined purpose, e.g. acceptance of consignments or batch release.
Shelf-life: The period of time during which a pharmaceutical product, if
stored correctly, is expected to comply with the specification as determined
by stability studies on a number of batches of the product. The shelf-life is
used to establish the expiry date of each batch.
Standard operating procedure (SOP): An authorized, written procedure
giving instructions for performing operations not necessarily specific to a
given product but of a more general nature (e.g. equipment operation,
maintenance and cleaning, validation, cleaning of premises and
environmental control, sampling and inspection).
Storage: The storing of medical products and health technologies up to the
point of use.
Supplier: A person or entity engaged in the activity of providing products
and/or services.
Thermolabile: A substance that is subject to destruction, decomposition, or
change in response to temperature.
Transit: The period during which medical products and health technologies
are in the process of being carried, conveyed, or transported across, over or
through a passage or route to reach the destination.
Vehicles: Trucks, vans, buses, minibuses, cars, trailers, aircraft, railway
carriages, boats and other means which are used to convey medical products
and health technologies

x
Validation: Action of proving, in accordance with Good Distribution
Practices, that any procedure, process, equipment, material, activity or
system actually leads to the expected results (see also qualification);
Withdrawal: The total removal of a pharmaceutical product from the market

xi
Acknowledgements

The Pharmacy and Poisons Board wishes to express its appreciation to the
CEO Dr. F.M Siyoi, the Director Health Products and Technologies Dr. A.
Mohamed and all those whose efforts and valuable contributions made this
guideline possible.

Foreword
The Pharmacy and Poisons Board is committed ensuring the availability of
medical products and health technologies in Kenya which satisfy the needs of
all citizens for the prevention, diagnosis and treatment of diseases using safe,
efficacious, high quality and cost-effective pharmaceutical products

Pursuant to this mission, it is imperative that pharmaceuticals are distributed

by highly qualified personnel through outlets that are duly licensed and
professionally run. Pharmaceuticals require specialized handling to ensure
their quality is maintained throughout the distribution chain and the risk of
exposing the public to unsafe medicines should be avoided at all cost.

This GDP guideline, which replaces the 2019 guideline, defines a number of
new provisions. They have been prepared to provide persons involved or
wishing to be involved in distribution Medical products and health
technologies with a method of assessing eligibility and the process of lawfully
operating distribution outlets. It further provides specific requirements on
distribution that are practices currently acceptable.

The success of this initiative will ultimately depend on the active contribution
and cooperation of every stakeholder. I trust that all will strive to uphold the
standards of practice in pharmaceutical distribution.

1
The pharmacy and poisons board strongly encourages the widespread
implementation of these guidelines and is ready to assist users in
implementing them.

Dr. F.M Siyoi

CHIEF EXECUTIVE OFFICER

2
INTRODUCTION

Legal framework
The pharmacy and poisons ACT CAP 244 laws of Kenya mandate the PPB to
regulate the trade in medical products and health technologies.
Distribution is an important activity in the integrated supply chain
management of medical products and health technologies. All parties involved
in the distribution of medical products and health technologies have a
responsibility to ensure that the quality of the products and the integrity of
the distribution chain are maintained throughout the distribution process
from the site of manufacture to the entity responsible for dispensing the
product to the end user.
Article 43 (1) (a) of the constitution of Kenya 2010 provides that every person
has the right to the highest attainable standard of health. Highest standards
of health are only attainable if the quality of medical products and health
technologies in the market are of the right quality.

General considerations

Organization structure and management

The distributor must be an entity that is appropriately authorized to perform

the intended function in terms of the applicable legislation, and which can be
held accountable for its activities by ensuring that:
i. There should be an adequate organizational structure defined with the aid
of an organizational chart. The responsibility, authority and
interrelationships of all personnel should be clearly indicated. This must
be duly dated, be current, valid and authorized.
ii. A designated qualified person (Pharmacist/ pharmaceutical technologist)
shall be appointed at each distribution outlet that has the defined
authority and responsibility for ensuring that a quality management
system is implemented and maintained.

3
iii. Managerial and technical personnel must have the authority and
resources needed to carry out their duties and to set up and maintain a
quality management system, as well as to identify and correct deviations
from the established quality management system.
iv. The responsibilities placed on any one individual should not be so
extensive as to present any risks to the medical products and health
technologies’ quality or process. Individual responsibilities should be
clearly defined and understood by the individuals concerned and recorded
as written job descriptions. Certain activities may require special attention
such as the supervision of performance of activities, in accordance with
legislation.
v. Duties may be delegated or contracted out to suitably designated persons
or entities as necessary and documented. There should, however, be no
gaps or unexplained overlaps with regard to the application of Good
Distribution Practices. These activities should be documented in quality
agreements or contracts. There should be periodic audits of such activities
concerning the application of Good Distribution Practices
vi. Any person who wishes to start the business of a pharmacy may first
consult the concerned Pharmacy and Poisons Board regional office for
guidance on suitability of proposed location prior to making financial
commitments.

Quality management system

Every distribution entity shall have a quality management system that

assures quality of medicinal products and health technologies. Senior
management should demonstrate its commitment to the development and
implementation of the Quality Management System (QMS) and continual
improvement of its effectiveness and performance by:
i. Communicating the importance of adhering to customer, regulatory
(Good distribution Practices) and legal requirements, including
environmental, health and safety aspects;
ii. Establishing functional quality objectives;

4
 iii. Ensuring regular reviews of quality management systems;
iv. Applying risk assessments;
v. Maintaining appropriate conditions throughout the organization for
processes and systems
vi. Ensuring the availability of resources to support quality management
system
vii. Ensuring the integration of quality management system into their
operations and processes.
viii. Supporting other relevant management roles to demonstrate leadership
as it applies to their areas of responsibilities.
ix. Ensuring that customer satisfaction is enhanced and maintained.
x. Establish a system for handling customer compliments and complaints

Every entity shall establish and maintain documented information on:

i. Standard Operating Procedures (SOPs) for all activities affecting quality,
safety and efficacy of medical products and health technologies;
ii. Work Instructions and Process Maps;
iii. Forms and Records.

Entities shall have in place effective measures for Risk Management to ensure
risks are controlled to such an extent unwanted outcome can be mitigated
adequately.

Additionally, wholesalers should annually conduct risk assessments to assess

potential risks to the quality and integrity of medical products and health
technologies. The quality system should be developed and implemented to
address any potential risks identified. The quality system should be reviewed
and revised annually to address new risks identified during a risk
assessment.

Personnel

1. Authorized personnel shall bear the responsibility of ensuring that medical

5
 products and health technologies are correctly handled, stored and
distributed. Such personnel should have the relevant education,
training, experience and/ or combination of these elements that will
allow them to effectively discharge this responsibility.
2. A pharmacy student may provide or perform all the services or acts
pertaining to the scope of practice as per the PPB Training guidelines
under the direct personal supervision of a registered pharmacist or an
enrolled pharmaceutical technologist.
3. Operating personnel should be trained to perform assigned duties and
functions at an acceptable level. Records of any training relevant to
their functions should be kept.
4. Procedures and job descriptions for employees and other persons
having access to the products must be designed and administered to
minimize the possibility of drugs coming into unauthorized possession.
5. During operating hours, the business must at all times be conducted
under the continuous personal supervision of a registered pharmacist
or an enrolled pharmaceutical technologist.
6. There must be an adequate number of competent personnel involved in
all stages of the distribution of medical products and health
technologies in order to ensure that the quality of these products is
maintained. Dispensing and medication use counselling is the
responsibility of authorized personnel only. Regulations by the relevant
authorities with regard to qualification and training of personnel should
be complied with.
7. Personnel involved in the wholesaling or distribution of medical
products and health technologies should be supplied with appropriate
personal protective equipment suitable for the activities that they
perform. Personnel dealing with hazardous medical products and
health technologies, including products containing materials that are
highly active, toxic and infectious or sensitizing, should be provided
with specialized protective garments as necessary.
8. Appropriate procedures relating to personnel personal hygiene and
sanitation relevant to the activities to be carried out, should be

6
 established and observed. Such procedures should cover health,
hygiene and clothing of personnel.

2.1 Premises, warehousing and storage

General requirements
1. Premises should provide protection for the goods from contamination
and deterioration, including protection from excessive local heating,
humidity/ moisture or undue exposure to direct sunlight.
2. Premises should be kept free of rodents, vermin, birds, pets and pests.
Storage of food products should be separated from medical products
and health technologies.
3. Premises should have dedicated and demarcated areas available for the
receipt of stock, general storage area, goods in quarantine, goods
rejected, cold-chain storage, goods returned, dispatch and storage of
medical products and health technologies. The goods received or
dispatched at receiving or dispatch bays, docks, platforms or areas
should be protected from dust, dirt and rain in line with GDP
4. The storage areas at a wholesaler should be of sufficient capacity to
allow the orderly storage of the various categories of medical products
and health technologies.
5. Warehousing of medical products and health technologies should be
carried out in permanent buildings or parts of permanent building that
have been built for, or adapted to warehouse medical products and
health technologies.
6. The layout of a pharmaceutical warehouse shall consist of Receiving
area, ordering /sales, dispatch, quarantine, and storage area.
7. The grounds should be established and maintained so as to minimize
ingress into the buildings of dust, soil or other contaminants and
should be maintained in an orderly condition. They should be free of
the accumulated waste, dirt and debris. Waste should be collected in
designated closed containers and disposed of at frequent intervals.

7
8. Premise must have a permanent address and be located at a site
approved by the local authority and/or other related Acts or
Regulations which must be adhered to by the licensee.
9. Where premises are not directly operated by the company, a written
contract should be in place. The contracted premises should have a
separate authorisation for distribution.
10. Where one has more than one storage or warehousing facility separate
from the main registered premise, a separate authorization for the
premise shall be sought.
11. Wholesale and retail practices shall be carried out separately in distinct
different premises.
12. Buildings should have sufficient security to help prevent pilferage of the
medical products and health technologies.
13. Sufficient space should be provided for the orderly receipt, warehousing
and dispatch of medical products and health technologies and, in
particular, a quarantine area for isolation when necessary, including
isolation of faulty packs and recalled goods.
14. Buildings and fixtures should be kept clean and well maintained.
Cleaning equipment should be stored in hygienic conditions.
15. Sufficient lighting should be provided to enable all operations to be
carried out accurately and safely.
16. Storage facilities should protect goods from deterioration. The
conditions of storage for goods should be compatible with the storage
conditions specified on their labels. All medical products and health
technologies should be stored off the floor.
17. Controlled storage environments, e.g. deep freeze, refrigeration, should
be monitored using suitable temperature recording devices and the
records reviewed and filed. Refrigerated and freezing storage
environments should be fitted with signals to indicate that refrigeration
has failed. The signal should permit resetting only by the authorized
person.
18. Temperatures and humidity conditions in other areas where goods
requiring specific storage conditions are held should be monitored and

8
 the results tabulated and analysed so as to demonstrate the suitability
of these areas for their purposes.
19. If any temperature and or humidity records are found to have deviated
outside the relevant recommended conditions for an extended time, the
products shall be quarantined and the report sent to the Quality Safety
and Efficacy (QSE) committee of the PPB for further direction.
20. Instruments or equipment used for monitoring temperature and
humidity should be calibrated by a Kenya Bureau of Standards (KEBS)
recognized agency on a regular basis to ensure their accuracy. The
reference used should be traceable to International and or National
Standards
21. Special storage facilities should be provided for Narcotic drugs,
psychotropic substances, precursors , Dangerous Goods ,or other
categories of goods as required by applicable legislation.
22. Incompatible activities such as manufacture (including repackaging) or
the handling of toxic chemicals should be avoided in areas in which
medical products and health technologies are handled by wholesale.

General Storage Areas

1. Precautions must be taken to prevent unauthorized persons from

entering storage areas.
2. Storage areas should have sufficient capacity to allow the orderly
storage of the various categories of medical products and health
technologies namely usable products, products in quarantine, released,
rejected, returned or recalled products.
3. Storage areas should be designed or adapted to ensure good storage
conditions. In particular they should be clean and dry and maintained
within specified temperature and humidity limits. Medical products and
health technologies should be stored off the floor and suitably spaced
to permit cleaning and inspection. Pallets should be kept in a good state
of cleanliness and repair.

9
4. Secure measures should be taken to ensure that rejected products
cannot be used and they should be stored separately from other
products while awaiting destruction or return to the supplier. The
measures adopted should possess adequate safeguards to prevent
uncontrolled or unsatisfactory medical products and health
technologies from being used or released.
5. Written procedures and a sanitation program should be available,
indicating the frequency of cleaning and the methods to be used to
clean the premises and storage areas.
6. A cleaning log must be in place, completed, signed and checked by the
appropriate designated person.
7. There should be a written procedure and a programme available for pest
control. The pest control agents used should be safe, and there should
be no risk of contamination of medical products and health
technologies. A site flow plan, indicating where the bait stations are
situated, must be available.
8. There should be appropriate written procedures available for the clean-
up of any spillage to ensure complete removal of any risk of
contamination.
9. There should be appropriate written procedures available for the
removal of spilled hazardous products and cytotoxic substances and
products to ensure any risk of contamination or health hazard is
controlled.
10. If sampling is performed in the storage area, it should be conducted in
accordance with a written procedure and in such a way as to prevent
contamination or cross-contamination.
11. Written procedures should be available for the isolation and control of
goods. Goods should be moved to a controlled area in the event of:
i. Medical products and health technologies that await release by
the Holder of the Certificate of Registration;
ii. Suspected and confirmed substandard and falsified medical
products and health technologies

10
 iii. Returned, damaged or expired medical products and health
technologies for disposal;
iv. Medical products and health technologies that have been recalled
or withdrawn from the market;
v. Medical products and health technologies that are being
investigated after a cold-chain failure;
vi. Instructions issued by the regulatory authority or the Holder of
the Certificate of Registration
12. Where quarantine status is ensured by storage in separate areas, these
areas must be clearly marked and their access restricted to authorised
personnel. Any system replacing physical quarantine should provide
equivalent security. For example, computerised systems can be used,
provided that they are validated to demonstrate security of access.
13. Physical or other equivalent validated (e.g. electronic) segregation
should be provided for the storage of rejected, expired, recalled or
returned products. The products and areas concerned should be
appropriately identified.
14. Radioactive materials, narcotics and other hazardous, sensitive and/
or dangerous medical products and health technologies, as well as
products presenting special risks of abuse, fire or explosion (e.g.
combustible liquids and solids and pressurised gases) should be stored
in dedicated areas that are subject to appropriate additional safety and
security measures that include but not limited to lock and key, security
cameras, restricted rights of access and frisking of persons accessing
the dedicated storage areas.
15. Medical products and health technologies should be handled and
stored in such a manner as to prevent contamination, mix-ups and
cross-contamination.
16. Broken or damaged items should be withdrawn from usable stock and
stored separately.
17. Storage areas should be provided with adequate lighting to enable all
operations to be carried out accurately and safely.

11
18. Sufficient warehouse security should be maintained to prevent
misappropriation of the goods by preventing unauthorised possession
of, or access to the product and to allow for appropriate stock control.
19. Stock losses should be minimised by taking the following appropriate
measures:
i. Restricted entry and exit points to the warehouse being used
ii. Vehicles (other than delivery vehicles) not being allowed near the
warehouse;
iii. All goods leaving the store being carefully checked against the
relevant documentation;
iv. Security checks of all vehicles entering or leaving the warehouse
area taking place;
v. High-risk goods being well protected, ideally in a separate area
that is sealed off from the rest of the warehouse with access
control;
vi. Implementing good housekeeping;
vii. Ensuring that workers are not able to leave the warehouse area
during working hours without going through security;
viii. Preventing theft by using appropriate security systems;
ix. Avoiding fires in the warehouse by removing combustible waste
materials several times a day. No-Smoking policies and notice
boards should be in place.
x. Fire fighting equipment should be frequently serviced and
maintained.
xi. Implementing and adhering to The Occupational Health and
Safety code. Details of the code should be displayed in the work
environment for all staff to see.

Storage conditions

1. Storage conditions for medical products and health technologies as

described by the product storage requirements should be in compliance
with the instructions on the label and package insert, which are based

12
 on the results of stability testing. When specified on the label, controls
for temperature, humidity, light etc. should be in place.
2. The warehouse should be maintained at a temperature not exceeding
30 °C, and a relative humidity not exceeding 75% Relative humidity
(WHO zone IVb requirements) at all times.
3. All warehouses should be temperature and humidity mapped over a
period of at least one year to determine the temperature distribution
under seasonal extremes.
4. Temperature mapping should be repeated every two to three years and
after every significant modification to the premises, stock layout or
ventilation system
5. Temperature monitoring should be done at strategic locations (hot and
cold spots identified from the temperature mapping process) covering
the stock containment areas and data recorded at least twice daily
(morning and afternoon) and records maintained. Temperature
monitoring should be in accordance with Storage requirements to
specifically reflect manufacturer’s label specifications, such as Oral
polio Vaccine (OPV), etc.
6. Continuous temperature monitoring devices or systems should be
validated.
7. Written procedures should be available describing the action to be
taken in the event of temperature deviating outside of the set standards
and conditions must be appropriately investigated. The fate of the goods
outside of the set standards must be decided by the Responsible
Pharmacist in consultation with the Holder of Certificate of
Registration.

Monitoring of storage conditions

At all times, Temperature and humidity should be controlled and

monitored using calibrated monitoring devices based on temperature
mapping.

13
 Recorded temperature monitoring data should be available for review.
The equipment used for monitoring should be checked at suitable
intervals and the results of such checks should be recorded.

Monitoring equipment should be calibrated once a year by a KEBS

approved agent and all monitoring records be kept for at least the shelf-
life of the stored medical products and health technologies plus one
year.

Good cold chain management Storage

1. All thermolabile products must be stored in a refrigerator/cold

room/freezer exclusively dedicated for medical products.
2. All thermolabile products must be stored in a refrigerator/cold room in
a temperature regulated environment between 2 °C and 8 °C or as per
the information on the product label; and the cold chain must be
maintained at all times, and records of the same kept for review when
necessary.
3. Thermolabile products that are required to be frozen must be
maintained at temperatures in accordance with manufacturers storage
requirements.

4. The temperature of the freezers for all products including coolants must
be temperature monitored.
5. Refrigerator, freezer or cold room must be connected to an alarm system
- in the event of a power failure or if the temperature limits are not met.
6. Refrigerator, freezer or cold room must be connected to a standby
generator or other emergency power system to ensure uninterrupted
power supply in the event of a power failure.
7. There must be a written procedure in place in the event of a power
failure.

14
8. Refrigerators, cold rooms and freezers used to store thermolabile
medical products and health technologies should at minimum:
a. Be well maintained;
b. Be equipped with temperature and humidity monitoring devices;
c. Be free from frost build-up;
d. Allow for adequate air distribution and orderly storage within the
chamber. Good storage practices and loading configurations
should not lead to the obstruction of air distribution.
e. Have sensors for continuous temperature and humidity
monitoring and alarms located at the points representing the
temperature extremes.
9. The refrigerator, freezer or cold room must be mapped in terms of
temperature.
10. Products should not be stored in areas shown by temperature
mapping to present a risk (e.g. in the airflow from the refrigeration unit).
11. Sufficient space should be maintained to permit adequate air
circulation especially between shelving. If the refrigerator is filled to
capacity, the effect on temperature distribution should be
investigated.
12. Ensure that no condensation from chillers collects or drips onto
product or collects inside the facility.
13. On receipt of a shipment of thermolabile stock, all cold chain items
should be moved to the refrigerator within the shortest possible time
from offloading the truck.
14. When a lagged container used for transportation of the product is
opened, all cold chain products must immediately be removed and
stored in the refrigerator, in order to maintain the cold chain. Checks
should be done to ensure that the cold chain has been maintained
during transportation.

GUIDELINES FOR GOOD RETAIL PRACTICE FOR

PHARMACEUTICALS

15
2.1.1 Nature and setup of premises

These guidelines will serve as the minimum acceptable requirements for

premises, which will be licensed as retail pharmacies.

1. The premises must be fixed. For the purpose of this guideline, a fixed
premise does not include a vehicle, trailer, caravan or any other thing
which may be transported on, in or attached to a vehicle. It does not
include unroofed and/or temporary structures. The premise should
meet all the relevant local bylaws and planning regulations.
2. A distance of not less than 200 metres shall exist between registered
premises per cadre of superintendent (pharmacist to pharmacist and
pharmaceutical technologist to pharmaceutical technologist).
For clarity, it is the Cadre of the superintendent under
consideration and not the cadre of the owner.
In addition, consideration shall be made as to the level of urbanization,
population status among other factors (streets, malls and metropolitan
cities).
The issue of distance between registered pharmacies does not apply to
registered hospital pharmacies.

3. The floors and walls will be made of washable and impervious materials,
and the ceiling covered with a non-flaking finish that allows for easy
cleaning.
4. The premises should be well lit, ventilated and secure. Measures on
security concerns including metallic grills and panels shouldn’t
undermine Good Pharmacy Practices including patient service.
5. The premises should be protected against adverse weather conditions,
ground water seepage, vermin and pest infestation.
6. The premises should have sufficient space for the carrying out of the
necessary operations.
7. There should be no overcrowding of customers and staff thus promoting
efficient flow of work, effective communication and supervision.

16
8. Premises should be well designed with sufficient spaces. This includes
an overall surface area not less than 4meters by 6meters, divided into
at least a dispensary (4meters by 2meters) and the general area
(4meters by 4meters).
9. Premises shall reflect the practice level, painted as white with a green
cross for pharmacists, and white with a blue cross for pharmaceutical
technologists. The crosses should be conspicuous and located before
and at the end of the premises name. In addition, branding to reflect
practice level is a requirement at pre-registration inspection. For clarity,
the color of the crosses shall be determined by the cadre of the
superitendent and not the cadre of the owner.

Above: Green cross branding for a retail pharmacy where the

superintendent is a pharmacist.
In the middle is the name of the pharmacy as the case may be

Above: Blue cross branding for a retail pharmacy where the

superitendent is a pharmaceutical technologist.
In the middle is the name of the pharmacy as the case may be

17
 10. Licensed premises should be used for the practice of pharmacy.
However, any other additional business activity beyond the practice of
pharmacy should be notified to PPB for approval.
11. Premises should have running potable water, toilet facilities, waste
disposal system and space dedicated for the storage of cleaning
equipment.
12. Premises should be maintained in a good state of repair and decoration.
When these processes are being carried out, they will not cause or tend
to cause any contamination of ingredients or products.
13. All products should be protected from light, heat and moisture and
there must be temperature-controlled storage facilities for ingredients
and drugs, which are sensitive.
14. Prescription only medicines (POM) must be separated from over the
counter drugs and narcotic and psychotropic drugs shall be kept in a
secure fixed and lockable storage place. Records of these products must
be maintained at all times, reflecting true stock balances. There should
be a lockable door separating the dispensary from the over the counter
area.
15. There should be a separate office or administrative office for the
pharmacist or pharmaceutical technologist, where prescription,
purchase records and other administrative records may be maintained
and it should be located so as to have a full view of the dispensary.
16. The number of registered pharmacist or enrolled pharmaceutical
technologist) per premises shall be determined by the workload at the
premises.

2.1.2 Equipment

There should be some basic equipment:

i. A tablet counter
ii. A refrigerator
iii. Appropriate litter bins
iv. Drinking water dispenser

18
 v. Weighing balance
vi. Measuring cylinders with a capacity to accurately measure volumes
between 0 and 100 ml
vii. Pestle and mortar
viii. Spatula and Slab

2.1.3 Reference materials

The following reference books and materials should be available and they
should be the latest editions

i. Guidelines
a. GDP guidelines
b. Safe management of Pharmaceutical waste
c. Product recall and withdrawal
d. Transportation of pharmaceuticals
ii. CAP 244 laws of kenya
iii. Professional code of ethics
iv. Reference books
a. British National Formulary
b. Martindale, the extra pharmacopoeia
c. Kenya Standard Treatment Guidelines
d. Kenya National Drug Policy
e. Lists of drugs that are registered in Kenya
f. East African Pharmaceutical Loci or
v. Any other text that gives trade names of drugs on the market.
vi. Online reference materials

2.1.4 Retail pharmacy licence

No person will be issued with a licence to operate a retail pharmacy, unless

the person complies with the requirements stipulated in the guidelines for
registration of premises including, but not limited to, the following:

19
 a. Is a registered pharmacist with the Pharmacy and Poisons Board.
b. Is an enrolled Pharmaceutical technologist with the Pharmacy and Poisons
Board, with three years post enrolment experience
c. Is not a holder of another such licence for a different premise.
d. Is not engaged as a pharmacist/pharmaceutical technologist in any other
enterprise
e. The premises has been certified for suitability by the Pharmacy and
Poisons Board’s inspectorate department.
f. Pays the prescribed fee.

2.1.5 Operations

Operations in the retail outlet shall ensure that:

1. The dispensing of prescriptions and sale of pharmacy only medicine
shall be under the supervision of a qualified pharmacist or
pharmaceutical technologist. Warehousing may be contracted out e.g.
for scientific offices, but only to Pharmacy and Poisons Board registered
warehouses. This should be documented in written contracts and
quality agreements
1. The Pharmacy shall not dispense any prescription or sell any Pharmacy
only medicine when the registered pharmacist/ enrolled
pharmaceutical technologist is not present.
2. No prescription only medicine is to be dispensed except in compliance
with a valid prescription written by a registered Medical Practitioner,
Dental Surgeon or Veterinary Surgeon.
3. Every retail pharmacy should keep and use suitable dispensing
containers and labels. The container shall be capable of keeping
dispensed medicines in a safe and usable condition.
4. A suitable and adequate prescription/patient recording system shall be
maintained which shall consist of a prescription record ledger well
indexed and up to date. This may be supplemented by patient profile
cards, a computerized system or any other approved recording system.

20
 5. Records of all stocks received their source, batch number, expiry date
and quantity received shall be maintained.
6. All records will be retained for a minimum of five years for narcotic
drugs and two years for other drugs.
7. All records should be available for inspection by the pharmaceutical
inspectors at all reasonable times.
8. Adequate personal hygiene and clothing should be maintained
throughout the working hours. Professionals shall wear white dust
coats with name tags clearly displayed. Non – technical staff will use
grey dust coats.
9. The retail pharmacy shall comply with these and any other requirement
as may be specified by the Pharmacy and Poisons Board from time to
time.

GUIDELINES FOR GOOD WHOLESALE PRACTICE FOR

PHARMACEUTICALS

Wholesale distribution forms part of the supply chain of manufactured

medical products and health technologies. Wholesalers are responsible
for effective, efficient and safe handling, storage and distribution of
such products. As such, these guidelines set out appropriate steps for
meeting these responsibilities.

2.1.6 Building and grounds

1. Warehousing of pharmaceuticals should be carried out in permanent

buildings or parts of buildings, made of stone/ brick that have been
built for, or adapted to this purpose. The minimum requirement in
square meters for storage space in a wholesale set up is 100M2.
2. The grounds should be established and maintained so as to minimize
ingress into the buildings of dust, soil or other contaminants and
should be maintained in an orderly condition. They should be free of
the accumulated waste, dirt and debris. Waste should be collected in

21
 designated closed containers and disposed of at frequent intervals, as
per the guideline on disposal of pharmaceutical waste.
3. Buildings should have sufficient security to help prevent pilferage of the
pharmaceuticals.
4. Buildings and fixtures should be kept clean and well maintained.
Cleaning equipment should be stored in hygienic conditions.
5. Sufficient lighting should be provided to enable all operations to be
carried out accurately and safely.

2.1.7 Facilities

1. Storage facilities should protect goods from deterioration. The

conditions of storage for goods should be compatible with the storage
conditions specified on their labels. All pharmaceuticals should be
stored off the floor.

2. Controlled storage environments, e.g. deep freeze, refrigeration, should

be monitored using suitable temperature recording devices and the
records reviewed and filed. Refrigerated and freezing storage
environments should be fitted with signals to indicate that refrigeration
has failed. The signal should permit resetting only by the authorized
person.
3. Temperatures in other areas where goods requiring specific storage
conditions are held should be monitored and the results tabulated and
analyzed so as to demonstrate the suitability of these areas for their
purposes.
4. If any temperature is found to have deviated outside the relevant
recommended conditions for an extended time, the manufacturer of the
goods should be consulted and the suitability of the product for use
resolved.
5. Instruments or equipment used for monitoring temperature should be
calibrated on a regular basis to ensure their accuracy.

22
 6. Special storage facilities should be provided for poisons, drugs and
addiction, “Dangerous Drugs” or other categories of goods as required
by applicable legislation.
7. Incompatible activities such as manufacture (including repackaging) or
the handling of toxic chemicals should be avoided in areas in which
pharmaceuticals are handled by wholesale.

2.1.8 Personnel
1. Pharmacists bearing the responsibility for ensuring that
products/materials are correctly handled, stored and distributed,
should have the education, training experience or combination of these
elements that will allow them to effectively discharge this responsibility.
2. It shall be the responsibility of the superintendent
pharmacist/pharmaceutical technologist to submit to the concerned
Pharmacy and Poisons Board regional office reports on
consumption/distribution of Narcotics and Psychotropic medicines on
a quarterly basis.
The superintendent should also provide an updated list of clients
preferably biannually in January and in July of every year.
Any superintendent should always officially notify in writing
PPB/Regional office whenever they are away from their registered
premises indicating the name and registration number of the
professional holding brief for them.
The superintendent pharmacist/pharmaceutical technologist for
active reporting of poor quality medicines and suspected adverse drug
reactions by retail pharmacies and wholesale pharmacies.
3. Operating personnel should be trained to perform assigned duties and
functions at an acceptable level. Records of any training relevant to
their functions should be kept.
4. Procedures and job descriptions for employees and other persons
having access to the products must be designed and administered to
minimize the possibility of drugs coming into unauthorized possession.

23
 5. During operating hours, the business must at all times be conducted
under the continuous personal supervision of a pharmacist or
pharmaceutical technologists.

2.1.9 Wholesale pharmacy licence

No person will be issued with a licence to operate a wholesale pharmacy,

unless the person complies with the requirements stipulated in the
guidelines for registration of premises including, but not limited to, the
following:
a. Is a holder of a certificate of Registration as a pharmacist from
the Pharmacy and Poisons Board
b. Is not a holder of another such licence for a different premise
c. Is not engaged as a pharmacist in any other enterprise
d. The premises has been certified for suitability by the Pharmacy
and Poisons Board’s inspectorate department.
e. Pays the prescribed fee.

2.5 Guidelines for Good Hospital Pharmacy Practice for

Pharmaceuticals.

2.5.1 Nature and Setup of premises.

1. The premises to consist of one room, at least 4 meters by 3 meters in

dimension, with lockable cabinets for controlled substances and
quarantined products.
2. Premises to have a designated office area for the superintendent, where
administrative activities will be done and records kept and maintained,
with full view of the pharmacy and where necessary a separate drug store.
3. The premises will be permanent in nature, made of materials providing
ease of cleaning and suitable sanitary conditions. All products will be

24
 protected from light, heat, moisture and there must be temperature control
facilities in the pharmacy area.
4. The premises will have suitable and adequate provisions for light and
ventilation, with hand wash facilities with clean running water, waste
disposal bin within the pharmacy with toilet facility and storage for
cleaning equipment.
5. The pharmacy design will include provisions for privacy for the patients
during service and sufficient space for carrying out operations.
6. The premises structure will be protected against adverse weather
conditions, ground water sippage, vermin and pest infestation.
7. Pharmacy premises to reflect the level of practice, painted as white with a
green cross for pharmacist, and white with a blue cross for pharmaceutical
technologist.

Above: Green cross branding for a hospital pharmacy where the

superintendent is a pharmacist.
In the middle is the name of the hospital as the case may be and the
word pharmacy

Above: Blue cross branding for a hospital pharmacy where the

superintendent is a pharmaceutical technologist.
In the middle is the name of the hospital as the case may be and the
word pharmacy

8. There should be restricted entry to the pharmacy.

25
9. There should be no other unauthorized activities within the hospital
pharmacy.

2.5.2 Hospital Pharmacy Licence.

No person will be issued with a licence to operate a hospital pharmacy, unless
the person complies with the requirement stipulated in Guidelines for
Registration of Premises including, but not limited to, the following:

1. Is a registered pharmacist with the Pharmacy and Poisons Board.

2. Is an enrolled pharmaceutical technologist with the Pharmacy and Poisons
Board.
3. Is not a holder of retail, hospital, wholesale or such licence for a different
premise.
4. Is not engaged as pharmacist or pharmaceutical technologist in any other
enterprise.
5. The premises has been certified for suitability by the Pharmacy and
Poisons Board’s Inspectorate Department.
6. Such a premise should have valid license from the Kenya Medical
Practitioners and Dentist Council.
7. Pays the prescribed fee.

2.5.3 Staff establishment

The Ministry of Health Human Resources for Health Norms and Standards
Guidelines for the Health Sector, August 2014 will apply. The minimum
requirement will be as follows;
1. Level 2 Hospitals. One pharmaceutical technologist
2. Level 3A Hospitals
 One pharmacist
 Three pharmaceutical technologists
3. Level 3B Hospitals
 One pharmacist
 Four pharmaceutical technologists

26
 4. Level 4 Hospitals
 Four pharmacists
 Ten pharmaceutical technologists
5. Level 5 Hospitals
 6 pharmacists
 10 pharmaceutical technologists
 At least one specialist pharmacist
6. Level 6 Hospitals
 Depending on specialization and workload

2.5.4 Operations
1. Quality assured Medical Products and Health
Technologies will be procured through robust and
appropriate process supervised by the superintendent
pharmacist or pharmaceutical technologist.
2. Pharmaceutical expertise will be available with relevant,
up to date, evidence-based information to healthcare
professionals prescribing, administering and monitoring
effect of drug at point of care.
3. Pharmaceutical staff will be integrated into clinical teams
in the hospital and provide safe and appropriate
pharmaceutical care directly to the patients.
4. The pharmaceutical staff will ensure that all aspects of
medicinal use within the hospital are safe.
5. Medicine to be prepared, labelled and dispensed by a
registered pharmacist or an enrolled pharmaceutical
technologist.
6. There will be systems of work established that are safe,
productive, support quality improvement, are regularly
audited and comply with relevant regulations.

27
 7. Patient care will be provided in secure, appropriate and
suitable environment, ensuring confidentiality and
dignity of the patient.
8. Suitable, appropriate and relevant records will be kept in
environment that is safe and in secure form.
9. For extemporaneous preparations, necessary SOPs and
Reference materials must be available.
10. Where manufacturing activities takes place,
necessary Good Manufacturing Practice (GMP)
requirements to apply.

2.5.5 Equipment (where necessary)

 Hot plate
 Weighing machines
 Source of clean water
 Dispensing Cylinders of various sizes
 Beakers
 Motor and Pestles
 Trituration Slabs
 Spatula
 Refrigerator
 Tablet/capsule counters

2.5.6 Reference Materials

1. PPB Guidelines
 GDP guidelines
 Safe Management of Pharmaceutical Waste
 Product recall and withdrawal
 Transportation of Pharmaceuticals
 Safety and Vigilance of Medical Products and Health Technologies.
 Guidelines for Implementation of Continuing Professional Development
for Pharmacy Practitioners
2. Cap 244 Laws of Kenya

28
3. Professional Code of Ethics
4. Reference books
 BNF – Latest Edition
 Standard Treatment Guidelines
 Kenya National Drugs Policy
 Hospital Formulary
 EA Pharmaceutical Loci
 Guidelines for Medicines and therapeutics Committee.
5. Any other text that gives trade names of drugs on the market

2.6 Guidelines for Good e-Pharmacy Practice for Pharmaceuticals

1. e-pharmacy” means business of distribution or sale, stock, exhibit

or offer for sale of drugs through web portal or any other electronic
mode.
2. Any person who intends to conduct the business of e- pharmacy
shall apply for grant of the registration to the Pharmacy and Poisons
Board through the prescribed portal.
3. The e-pharmacy registration holder shall inform the Boards
Licensing Department `in writing in the event of any change in the
constitution of the firm operating under the registration.

4. The e-pharmacy registration holder shall make provision for a duly

registered brick and mortar pharmacy outlets for supplies,
customer support, redress of grievances among other supportive
services, e.g., answering customer queries through a customer
helpline.

5. The HPT requested/ordered through e-pharmacy shall be

delivered to the patient by a registered pharmacist or enrolled
pharmaceutical technologist within the period of validity of the
prescription received from the patient.
6. For providers of e-pharmacy who link clients to existing Registered

29
 Pharmaceutical premises, such information must be shared with
PPB.
7. Information received by the e-pharmacy registration holder from the
customer by way of prescription or in any other manner shall not be
disclosed by the e-pharmacy registration holder for any other
purposes nor shall the same be disclosed to any other person.
8. Details of records /documents in regard to dispensing made
against a cash or credit memo generated through the e-pharmacy
portal shall be maintained by the e-pharmacy registration holder,
e.g., patient details, serial number and date of the cash/credit
memo, etc, for a period of at least six years.
9. The e-pharmacy registration holder shall not carry out e-pharmacy
business with respect to the drugs covered under the categories of
the Narcotic and psychotropic as referred to in the Narcotic Drugs
and Psychotropic Substances Act, 1985 (61 of 1985).
10. The e-pharmacy registration holder shall not advertise any
drug unless the advertisement has been approved by the Pharmacy
and Poisons Board.
11. The e-pharmacy registration holder shall maintain and
update, from time to time, the information regarding the drugs
availability, types of drugs offered for sale, supply channels or
vendor lists, details of registered pharmacists, registered medical
practitioner (if any) and any other requirements of the Pharmacy
and Poisons Act and rules there under, to Pharmacy and Poisons
Board.
12. The e-pharmacy registration holder shall demonstrate
adequate back up for their online data.
13. All products supplied through e-pharmacy should have a valid
market authorization from PPB.

30
1.0 Handling and control of medical products and health
technologies

Handling and storage of medical products and health technologies and

health technologies should be in accordance with established
procedures designed to prevent contamination or deterioration, damage
to packs or confusion of products. Particular care should be given to
maintaining the integrity of seals on packs of sterile products and
thermo-labile products. Attention should be paid to any special
instructions from the manufacturer relating to handling or storage of
the products.

Importers should take all reasonable measures to ensure that medical

products and health technologies are not mishandled or exposed to
adverse storage conditions at ports of entry e.g. airports.

1.1 Inward Goods – From Suppliers

Receiving bays should protect products from the weather. Receiving

areas should be designed and equipped to allow incoming containers of
products to be cleaned, if necessary before storage.

Stock should be received and examined for correctness against order,

for expiry date and for absence of damage. Additionally, the
registration/ retention status of these products MUST be verified with
PPB.

The wholesaler will ensure that received goods comply with PPB
approved labelling and packaging requirements.

There should be a system for the recognition and prompt handling of

drugs of addiction, or those products requiring specific temperature

31
 storage, of products that have a short shelf life and of any other
products that require special care.

Goods from suppliers rejected by the wholesaler because of error,

breakage, leaking containers or other faults should be placed in
quarantine until the matter is resolved with the supplier.

Goods bearing an expiry date must not be received or supplied after

their expiry date or so close to their expiry date that they are likely to
expire before they are used by the consumer.
1.2 Outward Goods – To Retail Pharmacies

Dispatch bays should protect products from the weather. Dispatch

areas should be designed and equipped to allow out going containers of
products to be inspected, if necessary, before dispatch.

Every wholesaler/ distributor must put in place a mechanism of tracing

the products distributed by their batch numbers. It is very necessary
to account for all the stock.

It is unlawful to sell products to unlicensed pharmaceutical outlets or

to unauthorized persons. The wholesaler shall keep an up-to-date
database of client’s registration status with healthcare regulatory
authorities.

The wholesaler shall at all times maintain a record of distribution of

their products.

1.3 Port Handling and Customs clearance

Where an organization, imports or distributes medical products for

more than one manufacturer, the importer shall identify the range of

32
 different requirements and accommodate them all within the same
carrier.

In ensuring quality, efficacy and safety, medical products should be

stored under conditions complying with instructions from the
manufacturer, in particular concerning appropriate humidity,
temperature and light requirements; this will ensure storage conditions
will prevent damage, deterioration or other adverse effects to the
medicinal products.

The use of actively powered systems using electricity or other fuel

source to maintain a temperature controlled environment inside an
insulated enclosure under thermostatic regulation especially for time
and temperature sensitive medical products and health technologies
are recommended for example refrigerated ocean and air containers,
temperature controlled trucks, cold rooms etc.

For temperature sensitive products, the authorized importer should

alert customs officials in advance of the anticipated arrival of
consignments so that necessary arrangements are put in place to
transfer to the designated storage facilities without breaking the cold
chain

1.4 Special/ temporary storage facilities at Ports of Entry

The requirements described herewith apply to temporary storage of

Medical Products and Health Technologies awaiting clearance and
release from Ports of Entry in the Republic of Kenya.
These temporary storage facilities include but not limited to the
following: Container Freight Stations (CFS’s), Warehouses, Customs
cage(s) and shades. These facilities store consignments as pre-
clearance procedures are being worked on. Consignments arrive into
the country through Air ports, Dry land ports, and Sea ports.

33
1.5 Handling during Importation of Medical Products and Health
Technologies

All import/export consignments containing Medical Products and

Health Technologies must be accompanied with import/export
authorizations from the Pharmacy and Poisons Board.

The Port of Entry to be used must be declared in the import/export

authorization permits by the consignee and shall be adhered to.

Importers/Exporters of medical products and health technologies and

Health Technologies shall declare to Customs and Drug Regulatory
Officials upon arrival or expected arrival of consignments of interest.

Pharmaceutical inspectors in collaboration with Customs officials and

importers/exporters will carry out physical examination of all imported
consignment of medicinal products and their documentation.

Where necessary, the pharmaceutical inspector will carry out random

sampling of medical products and health technologies in accordance
with laid down guidelines on sampling of medicinal products imported
into the country for drug analysis.

All products whose details cannot be verified or fall within the scope of
SSFF should be forfeited and destroyed as per provisions in the
legislation (Anti-counterfeit Act 2008).

Storage of all medical products should adhere to the following basic

requirements: -
i. Clean, dry and dust free storage facility
ii. Suitable space to allow cleaning and inspection

34
 iii. Surfaces and shelves in ware houses and shades should be
made of covered/and impermeable materials to enable proper
and safe cleaning in order to maintain product integrity.
iv. Storage areas should be adequately lit and ventilated in order
for tasks to be performed in the appropriate and safe manner
while ensuring product quality is maintained.
v. Adequate storage area for proper segregation and
arrangement of products to prevent cross -contamination and
mix-up.
vi. Temperature, moisture and humidity control tools and
protocols
vii. Prevent Exposure to light
viii. Direction the package should face
ix. Maximum number of packages staked above each other.

If the manufacturer requires products to be stored or transported at

certain conditions (e.g temperature and humidity) these conditions
shall be monitored and periodically recorded. Such records shall be
maintained and available for review.
If packaging labels do not include information about the required
storage and transport conditions, such information should be obtained
from the manufacturer.
Importers/Exporters of medical products and health technologies and
Health Technologies shall declare to Customs and Drug Regulatory
Officials upon arrival or expected arrival of consignments of interest
Pharmaceutical inspectors in collaboration with Customs officials and
importers/exporters will carry out physical examination of imported
consignments of medicinal products and their documentation as per
risk assessment reports.
Where necessary, the pharmaceutical inspector will carry out random
sampling of medical products and health technologies in accordance
with laid down guidelines on sampling of medicinal products imported
into the country for drug analysis.

35
 All products whose details cannot be verified or fall within the scope of
SSFFCP’s should be forfeited and destroyed as per provisions in the
legislation (Anti-counterfeit Act 2008)

1.6 Damaged Goods from Stock

Stock which has been damaged or withheld from sale and which is not
immediately destroyed should be placed in quarantine until disposal so
that it cannot be sold in error or, in the case of liquid leakage, cause
contamination to other goods.
Stocks of products with broken seals, damaged packaging or suspected
of possible contamination must not be sold or supplied.
1.7 Returned Goods

1.7.1 From customers

Goods which have left the care of the wholesaler should only be returned
to saleable stock if:
i. they are in their original unopened containers, in good conditions
and bear a valid expiry date;
ii. it is not evident that they have been subject to adverse conditions;
iii. they are packed separately from other goods and accompanied by a
separate Returns Note; and
iv. they have been examined and assessed by a person authorized to do
so. Such assessment should take into account the nature of goods,
and any special storage conditions they may quire. If necessary,
advice should be sought from the person responsible for the quality
assurance of the manufactured product.

Reconditioning or repackaging (including re- labelling) of medical products

and health technologies goods must not be carried out by wholesalers

36
unless such activity is specifically exempted by the PPB from the
requirement to hold a manufacturers license.

1.7.2 From recall

There should be a written procedure detailing the action to be taken in
recalling goods on behalf of their manufacturer or sponsor, subject to any
amendment necessary in specific circumstances.
The above procedure should be consistent with the “PPB Recall guidelines
for Pharmaceutical and allied products”. The Wholesaler should be able to
facilitate a recall procedure relative to the area to which goods have been
supplied. Recalls carried out should be documented and records of all
recalled goods received into the warehouse should be kept. A person
should be designated as responsible for execution and co- ordination of
recalls.
1.7.3 Inventory Management

Written procedures should describe the different operations which may

affect the quality of the products or of the distribution activity: receipt
and checking of deliveries, storage, cleaning and maintenance of the
premises, (including pest control), recording storage conditions,
security of stocks and on site, consignments in transit, withdrawal from
saleable stock records, including records of clients’ orders, returned
products, recall plans, etc. These procedures should be approved,
signed and dated by the person responsible for the quality system.

Invoices or packaging slips should be issued for each delivery and

accompany the goods.

Clear and readily available records should be maintained showing the

receipt and disposal of all products purchased and sold. Such records

37
should be kept in an accessible form and place for the appropriate
legislated period (currently five years).

Keep records of each sale or purchase, showing date of purchase

(supply) name of medicinal product, quantity received (or supplied)
name and address of suppliers or consignee. Records should ensure
traceability of the origin and destination of products, e.g. by use of
batch numbers in the order that they can be identified/ traced.

Periodic (at least annually) physical counts should be done, involve

counting all items and comparing the counts with the records.

The differences should be reconciled i.e. all significant stock

discrepancies should be investigated to check that there have been no
inadvertent mix-ups, incorrect issue and/or misappropriation of
medical products and health technologies; and any stock discrepancy
must be referred to the Responsible Pharmacist
A written procedure must be in place to ensure effective stock rotation.
Medical products and health technologies due to expire first must be
sold and/or distributed in accordance with the first expiry, first out
(FEFO) principles. Where no expiry dates exist for the medical products
and health technologies, the first in, first out (FIFO) principle should be
applied.
All stock must be checked regularly for obsolete and short dated stock
items. All due precaution should be observed to prevent the issuance of
such short dated or expired stock.
Medical products and health technologies with broken seals, damaged
packaging or suspected of possible tampering/ contamination must not
be sold or supplied and must be segregated pending an investigation
and decision.

38
1.7.4 Substandard and Falsified Medicals products (SF) and
Unregistered Products

Products which are suspected or confirmed to be SF should be kept in

a designated area apart from other medicinal products to avoid
confusion. They should be clearly labelled as “NOT FOR SALE”. The
Pharmacy and Poisons Board and the holder of the products
registration should immediately be informed
Where quarantine status is ensured by storage in separate areas, these
areas must be clearly marked and their access restricted to authorized
personnel. Any system replacing physical quarantine should provide
equivalent security. For example, computerized systems can be used,
provided that they are validated to demonstrate security of access.
Sale of unregistered medicines is not allowed, but should written
permission under the appropriate provisions in the Pharmacy and
Poisons Act be given by the Board, the following should be observed:
i. Records of sales should be kept. This may also include special
conditions imposed by the Board on giving the permission; and
ii. The medicines should be stored separately from other registered
medicines. The area should be clearly indicated as to its use to
ensure adequate control of sales.

Handling, storage, distribution or trade in SF products is highly

prohibited. Any such product encountered/ detected should be
quarantined and PPB be notified for necessary regulatory action.

1.7.5 Complaints

Complaints regarding the product or its packaging, as distinct from

those relating solely to matters within the wholesalers’ control, must be
notified promptly to the manufacturer or sponsor of the goods.
Complaints relating to the wholesalers’ own activity should be

39
 evaluated and measures taken, where appropriate, to prevent their
recurrence.

All complaints shall be comprehensively documented, as per inhouse

procedure for handling complaints.

1.7.6 Self-Audit

The System of Quality Assurance of the distribution outlets should

include self- audit. These inspections should be in line with the
principles of Good Distribution Practices and if necessary, to trigger
corrective and preventative measures.

The Authorized person should ensure that self-audit is performed and

any deviations are followed up and concluded. Written procedures for
self- audit should be established to provide minimum and uniform
standards.

Self-audit should be conducted in an independent and detailed way by

a designated and competent person, and should cover all aspects of
Good Distribution Practices.

The frequency of self-audit should be at least twice a year.

Audit reports should include results, evaluation, conclusions, and
recommended measures. These reports should be summarized and
periodically submitted to Senior Management as an integral part of the
management review process.

There should be an effective follow-up programme whereby company

management must evaluate both the report and corrective measures.
The follow-up activities should verify the effectiveness of the corrective
action taken.

40
1.7.7 Corrective Action and Preventive Actions (CAPA)

1.7.7.1 Corrective Action

Entities should have Corrective action procedures in place to eliminate

causes of existing non-conformities or other undesirable situations.

Corrective action procedures must be implemented and the

effectiveness of the results must be verified. It must be determined
whether the non-conformity is an isolated or a repetitive problem, and
any actions to be taken, if necessary.

1.7.7.2 Preventive Action

Entities should have Preventive action in place to prevent occurrence of

existing non-conformities or other undesirable situations.

Preventive action should be considered if there are opportunities to

improve the quality management system.

Corrective action is taken after nonconformities are identified.

Preventive action is taken when a potential non-conformity is identified
as a result of the analysis of records and other relevant sources of
information, such as:
(a) Statistical process control documents;
(b) Customer complaints;
(c) Review product, process and quality system information;
(d) Risk analysis and risk assessment of products and
processes.

Records relating to the product performance should be analyzed

regularly, to detect trends and to identify areas of risk that may lead to
non-conformities.

41
 The analysis should also determine how to prevent any identified
potential problems.
Information on preventive action taken must be part of the management
review to maintain and improve the quality system.

1.8 Validation
Wholesalers should have a Validation Master Plan. The Validation
Master Plan provides a summary of the company’s philosophy, policy,
intentions and approach to validation.
The following should be validated at minimum:
a. Warehouse premises: ambient and cold-chain storage conditions
including temperature mapping
b. Lagged containers
c. Cold-chain processes
d. Computerized systems and
e. Transportation systems

Validation should be conducted in accordance with a validation

protocol. A written Validation Report should be available after
completion of the validation exercise

1.9 Calibration

All measuring equipment must be calibrated in accordance with an

approved schedule that details which equipment requires calibration,
as well as the frequency of calibration. The frequency will depend on
the type of equipment used, as well as the purpose for which it is used.
It is the Authorized person’s responsibility to approve the calibration
schedule.

42
1.10 Electronic records
Data, especially, legal records, may be recorded by electronic data
processing systems but detailed procedures relating to the system in
use should be available and the accuracy of the records should be
checked.

A written detailed description of the system should be produced

(including diagrams as appropriate) and kept up to date. It should
describe the principles, objectives, security measures and scope of the
system and the main features of the way in which the computer is used
and how it interacts with other systems and procedures.

Only authorized persons should be able to enter or modify data in the

computer. Access should be restricted by passwords or other means.
User should have a unique identifier (User ID) for their personal and
sole use so that activities can subsequently be traced to the responsible
individual

Written procedures should be in place for the validation of

computerized systems in order to demonstrate security of access and
data integrity.
There should be a record of changes and deletions. Any alteration to an
entry of critical data (which must be defined by each organization)
should be authorized and recorded with the reason for the change in
accordance with the procedure. Consideration should be given to the
system creating a complete record of all entries and amendments (an
“audit trail”).
Records electronically stored should be protected by back-up transfer
on magnetic tape, microfilm, paper or other means, at regular intervals.
Back-up data should be stored as long as possible at a separate and
secure off-site location.

43
 Good Distribution Practices Certification
Based on an inspection report, the plan for corrective actions taken by
the inspectee(s) and recommendation by PPB GDP inspectors, a
premises shall be deemed compliant/non-compliant with regulatory
requirements and a Certificate of Compliance/Non-compliance with
Good Distribution Practices will be issued.
In the event that an inspectee wishes to appeal the decision, the appeal
should be submitted in writing to the Chief Executive Officer, Pharmacy
and Poisons Board within 30 days from the date of decision.

References
1. Constitution of Kenya 2010
2. Pharmacy and Poisons Act, Cap 244 laws of Kenya
3. PPB 2020-2025 Strategic plan
4. Code of ethics for PPB Inspectors
5. WHO Technical Report Series No.957,annexe 5. WHO good distribution
practices for pharmaceutical products.
6. European Medicine Agency. Good Distribution Practice.
7. Good Distribution Practice, TMDA, United Republic of Tanzania.

Revision history
Revision Date Reviewer Section(s) Description of change
No: revised
Revision 12/01/2022 Dr. Document To be in line with the new
No.0 Kariuki numbering organogram
2.5 Inclusion of guidelines for
hospital pharmacy
2.6 Inclusion of guidelines for
e-pharmacy

44
Controbutors/Reviewers
NAME POSITION
S.No

1. Dr f.m siyoi CEO, PPB

2. Dr. Ahmed Mohamed Director, Health products and

Technologies,PPB

3. Dr Dominic Kariuki Deputy Director, Inspectorate and

Enforcement, PPB

4. Dr Tom Kauki Regional Head, Central Region, PPB

5. Julius Kaluai Regional head, Nairobi Region, PPB

6. Dr Paddy Agoro Regional Head, Coast Region, PPB

7. Dr Kibet Chebeo Regional Head, North rift Region PPB

8. Dr Sibalile Simiyu Regional Head, South rift Region PPB

9. Dr Onesmus Kilonzo Regional Head, Western Region PPB

10. Dr Washington Oyoo Regional Head, Nyanza Region PPB

11. Dr James Gathogo Regional Head, Upper Eastern Region PPB

12. Dr Benson Kanji Regional Head, Lower Eastern Region PPB

13. Omar Sheikh Regional Head, North Eastern Region PPB

14. Peter Kiptoo Head POE, PPB

15. Denis Otieno Head DCI, PPB

45
 END OF DOCUMENT

© Pharmacy and Poisons Board 2022

All rights reserved. This is a controlled document.

It must not be copied without authorization from the Pharmacy

and Poisons Board•

46