Name of the Region/Zone/Woreda/Agency

Regional Logo FORM No.: 001

Community Pharmacy Post-Inspection Checklist SOP No. ............

Title: Revision No:
INSTRUCTION: This checklist is designed to audit community pharmacy service procedures, processes, and
practices, including other related requirements. The requirements focus on the standards to practice in the
community pharmacy based on the standard and legislatives. Complete all sections and write all verification
responses and comments.
5. General Information
5.1. Level of community pharmacy 5.7. Address Date of Audit
a. Pharmacy Yes No a. Region: (dd/mm/yy)
b. Drug shop Yes No b. Zone:
5.2. Name of pharmacy/Drug Shop_________________
c. Woreda:
d. House No if applicable : _______ _____________
5.3. Name of Technical Manager ___________________
5.4. Contact Person (Pharmacy or Drug Shop):_________
e. Phone No:
5.5. Professional Level of Technical f. Specific location:
Manager_________________
Auditor(s):Name 1) __________________________
2) __________________________
3) __________________________
Audit finding
Verification/ Other
No Requirementsfor Audit o
assessment Yes N remar
k
1. Licensing status

1.1. Validity of license  License issue date

 Check legality
status
 Check license No
1.2. License displayed in a clear place  Check originality
and
 Displayed
prominently
2. Pharmacy personnel registration
2.1. Licensed pharmacist on duty  Check copy of
professional
license
2.2. License up-to-date  Check expiry date
3. External Appearance

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 3.1. Is the pharmacy or Drug Shop name clearly and  Observation
prominently displayed at the near public entrance?
3.2. Accessibility of entrance to people with disabilities  Physical
observation and
compliance with
standards
3.3. Are promotional materials displayed on windows, • Physical
doors, or any exterior part of the pharmacy or drug observation
shop?
3.4. Is the pharmacy or Drug shop maintained in a  Visual
clean and hygienic condition? inspection and
maintenance
checks
3.5. Are there accumulations of waste or debris around the  External
pharmacy premises or waste depot? Premises
Inspection
3.6. Are storage areas within the pharmacy self-  Inspection of
contained, No connection with doors and/or storage areas
windows with other premises and structural
integrity
4. Dispensing premises

4.1. Is there a designated appropriate waiting area for  Location and

customers or patients within the pharmacy? Accessibility
4.2. Are the walls and floors in the dispensing area made of  Visual
washable materials for easy cleaning and maintenance? inspection of
the dispensing
area
4.3. Is the dispensing area clean, organized, and free from  Visual Inspection
clutter? and check if there
is regular cleaning
schedules
4.4. Are all medications kept out of reach from customers  Ensure that
and not accessible for self-service? shelves or display
areas do not allow
customers to
access
medications
directly
4.5. Is the pharmacy or drug shop properly illuminated to  Illumination

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 ensure safe and accurate dispensing of medications? Check
4.6. Is there adequate ventilation in all areas of the  Ventilation Check
pharmacy or drug shop, including the dispensing area
and storage rooms?
4.7. Are all medicines protected from direct sunlight  Inspection of
exposure or positioned away from windows or other storage areas
sources of direct sunlight?
4.8. Are medicines stored separately from non-  Check shelves
pharmaceutical products such as cosmetics, food items, and fridge
or other goods?
4.9. Is access to the dispensing area restricted to authorized  Check physical
personnel only? barriers and
signage
4.10. Is the dispensing area appropriately sized and arranged  Layout and space
to allow for effective communication among staff evaluation
members ,direct supervision of staff, safe and efficient
workflow?
5. Dispensing practice

5.1. Is there a written Standard Operating Procedure (SOP)  Review of SOP

for dispensing of medicines? Document

5.2. Are patients provided with appropriate counseling  Counseling check

when receiving dispensed medicines?
5.3. Are all dispensed medications recorded in a logbook or  Logbook review
digital record for tracking purposes?
5.4. The pharmacy shall keep individual information of  Review of patient
chronic patients and their medication profile for each profiles
refill visit ?
5.5. Are medicines prescribed according to the standard  Prescription
treatment guidelines (STG) and in alignment with the review and
national formulary? dispensing
practice
5.6. Are all medicines properly labeled with the required  Check labeling
information before being dispensed to the patient? compliance
5.7. Is the counseling area designed to ensure patient  Counseling area
confidentiality and a comfortable environment for
discussing health concerns?
5.8. Are medicines stored on shelves in an organized  Check shelving
manner, following a clear and logical arrangement such arrangement
as alphabetical, pharmacological, or another systematic

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 method?
6. Compounding

6.1. Is there a written Standard Operating Procedure (SOP)  Check the content
for compounding available in the compounding room? of the SOP
If applicable.
6.2. Are the compounded products prepared in the  Review of
pharmacy derived from a list of permitted permitted list
preparation.If applicable .
6.3. Are the ingredients used in compounding sourced from  Check supplier
reputable suppliers and are they pharmaceutical grade? verification and
If applicable. pharmaceutical-
grade ingredients
6.4. Are all compounded medicines properly labeled with  Check the content
all the required information before they are dispensed of the label
to the patient?
6.5. Are there established cleaning procedures in place to  Check cleaning
ensure the compounding environment remains sanitary procedure if any
and suitable for preparation of medicines?
6.6. Is the compounding room kept clean, organized, and  Check
free from contamination? If applicable compounding
room cleanliness
6.7. Is all compounding in the pharmacy performed by a  Check the staff
licensed pharmacist? If compounding is done by other qualifications
staff (e.g., pharmacy technicians), is it reviewed and
checked by a licensed pharmacist before dispensing?
6.8. Are all compounded medicines properly documented in  Review of
a log book? compounding log
book
7. Prescription

7.1. Is a standard prescription form used for dispensing non-  Compare the
NPS (Non-Prescription Substances) medicines? prescription with
the standards one
7.2. Is there a prescription registration book maintained for  Inspection of
prescription-only medicines? prescription
registration book
7.3. Does the prescription contain all necessary details, such  Evaluate sample
as patient information, medication information, facility prescription
details, and professional information?
7.4. Is the prescription legible, complete, and accurate in all

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 aspects? • Evaluate sample
prescription
7.5. Is the prescription an original (not copied or forged)  Check the
and not written on plain paper? signature of the
prescriber and
check for
originality
7.6. Are prescriptions typically filled with 2-3 medicines  Evaluate sample
per prescription? prescription
7.7. Are medicines prescribed using their generic names  Evaluate sample
rather than brand names? prescription
7.8. Is it ensured that prescription-only medicines (POM)  Audit the
are not dispensed without a valid prescription? prescription
against the stock
available.
7.9. Are prescriptions from a given facility and prescriber  Evaluate sample
being monitored for frequency? prescription
7.10. Are dispensing pharmacists reviewing patient  Review dispensed
medication profiles to prevent potential harm from medicines
interactions or contraindications?
8. Adverse drug reaction and product defect reporting

8.1. Is a Prepaid Yellow Page available in the pharmacy?  Check ADE

reporting format
8.2. Are there any reported adverse drug reactions (ADRs)
or product quality defects associated with the medicines
dispensed? If present
9. Supply chain of Medicines

9.1. Are bin cards and stock cards regularly updated with  Check bin and
accurate records of stock movements and inventory stock cards
levels?
9.2. Are there appropriate vouchers, sales tickets,  Check the
dispensing registers, and other relevant documentation availability and
tools available and in use in the pharmacy? legality.
9.3. Are bin cards and stock cards regularly updated with  Check the records
accurate records of stock movements and inventory
levels?
9.4. Is the pharmacy following a FIFO (First-In-First-Out)  Take sample and
or LIFO (Last-In-First-Out) method to manage the flow check the flow of
of medicines? the medicines

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 9.5. Are the beginning and ending stock balances accurately  Review sample
recorded? medicine
9.6. Are the medicines available traceable to their source,  Check the legality
and legality of the medicine and the source of the of Medicine
medicine? against invoices
9.7. Is medicines purchased with appropriate professionals?  Check for non-
pharmacist
engagement in the
pharmacy
9.8. Is availability of any program medicine and non-  Take sample
confirmation of its source? program medicine
9.9. Should daily medicine sales be recorded?  Check sales
records
9.10. Are suppliers, wholesalers, or distributors licensed in  Trace back to the
Ethiopia? Suppliers or
wholesalers or
distributors
10. Recording and report

10.1. Shall all records be kept?  Review records

10.2. Should prescriptions be kept in the pharmacy for at  Review records
least two years?
10.3. Should any order, storage, preparation, sale, delivery,  Review records
and disposal be recorded and maintained?
10.4. Should all unfit-for-use medicines, including damaged  Review records
or expired medicines, be recorded?
11. Narcotic and psychotropic medicines (controlled
substances)
11.1. Should stock on hand and dispensed controlled  Check records
substances be recorded and maintained?
11.2. Should there be a separate locked room or cabinet,  Ask for the key
with the key kept by the head pharmacist? and check
11.3. Should controlled substance storage cabinets be  Check it
permanently affixed?
11.4. NPS prescription should not be used to prescribe other
medicines
11.5. Should NPS and other medicines not be prescribed  Check NPS
together, and should a single prescription be issued for prescription paper
a single NPS drug?
11.6. Should prescription paper for NPS be maintained in  Check NPS
the pharmacy for at least five years? prescription paper

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 11.7. Should a filled and officially signed prescription be  Evaluate the
used? Should the patient details, medication details, and prescription
professional details of the prescription be checked?  Check the stamp
Should the legibility, completeness, and correctness of of facility from
the prescription, as well as the serial number, be where the
verified? prescription came
11.8. Should regular reports be submitted to the appropriate  Evaluate report
regulatory organ regarding the consumption and stock  Current written
of controlled drugs? controlled drugs
report
11.9. Should all records of NPS be stored securely?  Evaluate Records
12. Staff appearance and credentials

12.1. Are licensed pharmacists available in the pharmacy?  Check human

resource file
12.2. Do all the pharmacy personnel on duty have name tags  Check content of
with clear responsibility and profession? the name tag
12.3. Does the head pharmacist have at least three years of  Check it
work experience?
12.4. Do all staff have a job description?  Check JD
12.5. Should pharmacy personnel wear appropriate and neat
gowns, and should they be distinguishable from other
staff?
12.6. Is training information of the staff available? Check HR file
13. Reference materials

13.1. Is the current edition of the dispensing manual,  Check

national treatment guideline, and national formulary availability
available?
13.2. Is the availability of other reputable reference books  Check
ensured? availability
13.3. Is a telephone available for providing medicines  Check
information? availability
14. Medicine Storage area

14.1. Are all medicines stored correctly under conditions  Check room
not affected by moisture, temperature, and light? temperature
 Check patterns of
the recorded To
and RH
 Valid availability

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 Termohygrometer
14.2. Are proper temperature control measures in place?  Check the
availability
14.3. Should medicines be stored unpacked?  Check it with
pyshical
inspection
14.4. Are no medicines stored on floors, stairs, and  Check adequacy
passageways? of storage
14.5. Is the storage area maintained in a good state of
repair and with washable walls?
14.6. Should damaged or expired stocks be stored  Check the record
separately from the usable stock? and place of the
storage
14.7. Should liquid products be placed on the lower or  Check the
bottom shelves? arrangement
14.8. Should flammable liquids be stored in their original  Check it
container and separately ?
15. Equipment and materials

15.1. Is the refrigerator equipped with a suitable  Check records

thermometer?
15.2. Are functional blood pressure, height & weight  Check calibration
measurement, and blood glucose devices available? and sample
records
15.3. Is there a suitable and hygienic means of counting  Check the
tablets and capsules? instruments and
observe
15.4. Should a dispensing balance be regularly checked  Check calibration
for accuracy? If applicable.
15.5. Should dispensing labels and envelopes contain  Check the
appropriate information? appropriateness of
the information
on the label and
envelop
16. Safety and Security

16.1. Are fire exit routes clearly indicated?  Check indications

16.2. Is a calibrated and functional fire extinguisher  record ofregular
available in the pharmacy? firealarm and
extinguisherchec
ks if any

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 16.3. Is a first aid package available?
16.4. Is the smoking policy in essential places of the pharmacy  Check any no
available? smoking label
16.5.Is waste appropriately recorded and disposed of?  Check disposal
certificate
17. Internal audit

17.1. Should self-assessment be conducted quarterly, with  Check the filled

reporting on scoring, identifying strengths and gaps, checklist
preparation of an action plan for the identified gaps, document
and reporting to the ZHD/Woreda/Town regulatory  Check the
body? remainder of
quarterly
reporting sent
17.2. Does the pharmacy service provision comply with the  Check the score
standards? & verification
feedback by the
regulatory body

Inspection findings
summary:__________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Audit inspectors
comment:__________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Other steps to be investigated by the regulatory/ should be filled secretly:
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

I confirm that the above filled information/data is true about the pharmacy.
Name of pharmacy head
_________________________________________________________

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Signature _________________ Date ________________stamp___________
Rank from 100%_______________________

Categoraization of the facility: Red Yellow Green

Name of auditors:

S.N Name Title Signature Date

1.

2.

3.

At the end of the Audit, thank the management body and all staff of the pharmacy who
participated in the Auditingprocess and cooperation. Present warm greetings.

Use the following Tracer Medicine for sampling

 Artemether + Lumifantrin 20/120/ Coartum
 Chloroqine tablet and suspension
 Premaquine tablet
 Qunine tablet and injection
 Artemether injection
 Artusunate injection
 Malaria Rapid Test Kit(RDT)
 Azytromycine tablet and suspension
 Antibiotics(Ceftriaxone inj, Tetracycle 250mg cap, Vancomycine, etc)
 Tetanus vaccine(TAT)
 NPS Drugs (morphine, pethidine, diazepam)
 Insulin injection
 Sildenafil Citrate with different brands
 Mannitol IV fluid
 Anti-D
 Anticancer (Cisplatin, Methotrexate, 5-flourouracil)
 PTU
 Warfarin

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 Glucose 40%
 Metronidazole injection
 Hepatitis B injection

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