LIST OF STANDARD OPERATING PROCEDURES

ORDER CODE PROCEDURE

1 POES 001 DEVELOPMENT OF THE STANDARD OPERATING PROCEDURE

2 POES 002 TRAINING FOR PHARMACY STAFF

3 POES 003 RECEPTION AND ENTRY OF PHARMACEUTICAL PRODUCTS,

MEDICAL DEVICES AND HEALTHCARE PRODUCTS

4 POES 004 STORAGE OF PHARMACEUTICAL PRODUCTS

MEDICAL DEVICES AND SANITARY PRODUCTS

5 POES 005 DISPENSING OF PHARMACEUTICAL PRODUCTS

Medical devices and sanitary products

6 POES 006 SALE OF PHARMACEUTICAL PRODUCTS, D.M. AND P.S.

7 POES 007 EVALUATION OF A MEDICAL PRESCRIPTION

8 POES 008 MANAGEMENT OF RETURNS AND PRODUCT EXCHANGES:

REGISTERS AND CAUSES

llamaa9 POES 009 WITHDRAWAL OF EXPIRED MEDICATIONS,

DETERIORATED AND THEIR DESTRUCTION

10 POES 010 INVENTORY CONTROL AND STOCK MANAGEMENT PRODUCTS

PHARMACEUTICALS, MEDICAL DEVICES, AND OTHERS

11 POES 011 CLEANING OF THE PHARMACEUTICAL ESTABLISHMENT - DISPENSARY

12 POES 012 SANITIZATION AND FUMIGATION OF THE ESTABLISHMENT

PHARMACEUTICAL-BOTIQUE

13 POES 013 WORKPLACE SAFETY OF STAFF IN THE

PHARMACEUTICAL ESTABLISHMENT - DISPENSARY

14 POES 014 CONTROL OF AMBIENT TEMPERATURE AND HUMIDITY

RELATIVE

15 POES 015 OFFICIAL OCCURRENCES BOOK REGISTRATION

16 POES 016 NOTIFICATION OF SUSPECTED RAM PHARMACOVIGILANCE

17 POES 017 NOTIFICATION OF SUSPICION OF ADVERSE INCIDENT TO

MEDICAL DEVICES

18 POES 018 MANAGEMENT OF PSYCHOTROPIC PRODUCTS - LIST IV B

ANNEXES
 POES N-1

PAGE: 1 of 6

GENERAL ASPECTS:

This document must be easy to read and understand for all staff working.
in the box.

Any questions and/or non-conformities observed during its application must be consulted and
communicated to the immediate superior.

When preparing the Poes, the guidelines specified in this procedure will be followed.

Any new poem necessarily replaces the previous one.

It is the responsibility of the Technical Director of the botca to maintain and keep an orderly control.
of the corresponding Poes and that remain in the area of application.

The Poes will be reviewed and/or updated when there is any modification within the deadline.
in force by the Technical Director of the botca, and approved by the owner of the
establishment.

1-OBJECTIVE

Establish the necessary guidelines to standardize and unify the directives to follow.
in the preparation of a regulatory document called Standard Operating Procedure
(hereinafter Poes). Likewise, establish the mechanism

Of coding, distribution, correction, modification, and annulment of obsolete POEs at the level
of the entire establishment.

2. Scope

Applies to all staff working at the Botca.

3.Frequency

This procedure applies beforehand to the preparation, control, and updating of everything
standard operating procedure, the frequency will depend on its validity, update of
norms, modifications or others.

4. Responsibility
The Pharmaceutical Chemist - Technical Director of the pharmacy, is responsible for preparing,
distribute, train, and supervise compliance with the Standard Operating Procedures
(Poems)

The owner is responsible for approving such procedures and providing all the material.
necessary logistics.

5. DEFINITIONS.

Standard Operating Procedure (SOP). It is a sequential, detailed description in the form of

simple and brief, on how a specific operation of any process must be carried out to
cabo.
 POES N02 PAGE: 2of6

6. PROCEDURE:

6.1 ELABORATION, REVIEW AND APPROVAL

The development of a standard operating procedure (SOP) is within the competence of

Technical Director of the botca.

The original of all POES will be called matrix POES. The matrix POES will be in charge of
Technical Director of the botca.

The preparation and review of the original POES or matrix for its application must be carried out by
the Technical Director of the botca, and the approval must be by the owner of the establishment
pharmacist.

This Review and approval of the POES and with a pen of blue or black color.

6.2 CONTENT IN THE HEADER

NAME OF THE PHARMACY will be located in the top left corner of the POES header.

TITLE AND SUBTITLE:

The title must always be STANDARD OPERATING PROCEDURES (SOPs), it must be used.
font: Arial, size 10 and bold.

The subtitle must clearly indicate which process, directive, or instruction the POES refers to.
It should use Arial font, size 12, and in bold.

POES N- BMX-YYY

WHERE:
BMX: Acronym for MAXI PHARMACY

SOP: Standard Operating Procedure

YYY: 3-digit numerical sequence

Page numbering of each POES

. Code (Bxxxx). It will be made up of 3 folders:

 POES N001 PAGE: 3 of 6

-First: The first two letters indicate the initials of the commercial name of the Botca: BMX

Second: Following a hyphen are three letters that identify the document. Yes, it is
procedure "POES" if it is a "REG" record.

Third: it is a number of 03 digits referring to the identification that increases

consecutively as the procedures of Botca increase, starting with 001.
The version of the POES is also recorded, and it is recorded on the right side.

b) Date of Issue, preparation and review: indicates the date on which the POES was created and
Reviewed. The approval of the POES must be obtained sufficiently in advance so that the
The document has been transmitted and read by all personnel working in the establishment.
before the POES comes into effect.

Dates are expressed: Day-Month-Year. >Example: 26-03-2017

Issue Date (I. D): The month and year of the document's issuance is indicated.

Date of Preparation (D. Prep.): in case of new POES.

From the first review carried out on the >POES. Version 001

-Number of pages: The page number is placed indicating the corresponding number
about the total number of pages of procedure 1 of 5

c) Edition: Refers to the authors of the preparation and approval of the POES. To the change of a
D.T. and/or owner, corresponds to Edition N-002.

D) Validity: Refers to the useful life time, which begins from its approval. All POES
it is valid for a maximum of 2 years.

E) Version. Correlational numbering (three digits) that indicates the number of revisions made.
to the POES from its preparation. Reviews are mandatory once every two
years, however, it also applies a review before this period, if it is necessary to carry out
a modification in the content of the POES. A new POES corresponds to Version N-002. The
Revisions do not necessarily mean modifications in the POES.

F) PAG_: Indicates the current page number and the total number of pages of the POES.

Example on the first page: Page 1 of 3

Example on following pages: 2 of 3; 3 of 3.

g) Header of subsequent pages: Indicates the POES number and page number.
Example:
 POES001 PAGE 4 of 6

DEVELOPMENT OF STANDARD OPERATING PROCEDURES (SOPs)

TRAINING OF THE STAFF OF THE MAXI PHARMACY

h) Footer of the POES: They will be signed by the personnel responsible for the preparation,
Review and Approval; these signatures will be placed at the end of each page of the POES (according to design)
attached

Prepared and reviewed by: Approved by:

Technical Director Owner.

i) Prepared by: person, position, and signature of the person who prepared the POES. Applies only
in new POES.

j) Reviewed by: Applicable from the second revision and replaces "Prepared by"
indicating the name and position of the person who reviewed the POES.

k) Approved by: Record the name of the person who approves the document, their position, and signature.

The procedures will be reviewed 30 days before the due date.

validity; for its modification or ratification of its content

6.3 CONTENT:

The text of a POES must be written on A-4 bond paper. The design of the header and footer
The page must be in accordance with what is established in the points mentioned above.

Regarding the content of the procedure: When it is necessary to highlight titles and subtitles
It will be written in uppercase and bold. The content is written in ARIAL font.
size 11.

Every POES must always contain the following points in chronological order:

A) Objective: Describe the purpose or define the reasons for developing a procedure.
B) Scope: Determines who executes the POES.
C) Frequency: Indicates the periodicity or number of times that it should be applied or executed.
POES. This frequency can be defined and is expressed in time (daily, monthly,
annual, etc.) or indefinite (for example: when required).
 POES001 PAGE 5 of 6

D) Legal Basis and/or References: It refers to the current regulations that are taken as
regulatory support for the development of activities.
E) Definitions: Clearly and precisely describe the meaning of some words or
abbreviations used in the development of the procedure.
F) Procedure or Development: Describe sequentially and logically the steps to follow.
a defined process.
Precautions and Recommendations (optional): Describe auxiliary information
necessary for the understanding and/or execution of the POES.
H) Annexes (optional): List the necessary documents for the execution of a POES.
These annexes may be referred to within the different points that are part of
from the POES or place them at the end as a separate point. Example: formats, records,
forms, or other complementary documents to the procedure.

6.4 DISTRIBUTION OF POEMS

The original POES and its distribution control sheet will be filed with the signatures of
the receivers, under the responsibility of the Technical Director of the Botca.
A controlled copy will be provided that will be available for the staff working in
the Botca.

6.5 MODIFICATION OF THE POES

A procedure is modified when any point of its content changes.

name, objective, place of application, responsibility, description, etc.) and can
to be carried out at the end of the validity period or earlier if the case requires it, with the
purpose of updating and improving it.
Any modification to the POES implies a new review.
The paragraph or paragraphs of the POES that have been modified will be indicated in the POES.
modified with a vertical line on the right side (l).
The modified POES is reviewed and approved following the indicated guidelines.
previously.

6.6 INVALID POES

They are presented in the following cases:

The POES that have reached two years of validity and have been subjected to mandatory
a biannual review by the D.T, as established in this POES.
POES that have been modified before the expiration of their validity date.
POEs that have been canceled and not replaced due to having lost applicability in the
Botca.
 POES001 PAGE 6 of 6

POEs that have been canceled and replaced by other POEs due to the changes
operational and functional in the Botca.
These inactive POES are immediately withdrawn and filed, labeled as
OBSOLETE, and the inclusion of the new POES is given.

7. PRECAUTIONS AND RECOMMENDATIONS

The Technical Director of the Botcatene is responsible for enforcing the POES.
sensitizing and socializing the POES with the personnel involved in the execution of the
procedure.
The review is relative, depending on the absence of internal modifications of the
Before the promulgation of a new regulation by the National Authority
Medications (ANM), which implies the modification of some procedure.

8. DISTRIBUTION
Owner
Technical Director
Pharmacy Technical Staff

9. CHANGE CONTROL:

No. Version Approval Date Description of the Change

10. CERTIFICATE OF DISTRIBUTION AND ACCEPTABILITY OF THE POES

It must be included at the end of each POES, in order to provide evidence on the
knowledge and acceptance of the procedure by the responsible personnel of
execute the activities.
You must indicate the following. With my signature, I confirm that, on the indicated date,
I have received, read, and understood the present POES.

Names and Surnames Company Date

1.

2.

3.

4.
 POES 002 PAGE 1 of 3

STAFF TRAINING

1. OBJECTIVES

The present procedure aims to establish the training criteria for

new or old staff, who works at the Botca, to ensure that the staff is provided
with the optimal skills to perform their duties.

2. SCOPE

This procedure applies to all new and old staff working at the Botca.

3.LEGAL BASIS

Law No. 26842-General Health Law.

Law No. 29459 Law on Pharmaceutical Products, Medical Devices, and Products
Sanitary facilities.
Law No. 28173. Law of the Pharmaceutical Chemist's Work in Peru.
Supreme Decree No. 023-2001-SA. Regulation on Psychotropic Substances
other substances subject to Health Regulation.
Supreme Decree No. 014-2011-SA Approves Regulations for Establishments
Pharmacists and their amendment (Supreme Decree No. 002-2012/SA).
Supreme Decree No. 016-2011-SA - Approves Regulations for Registration, Control
and Health Surveillance of Pharmaceutical Products, Medical Devices and
Sanitary Products and their amendments.
Ministerial Resolution No. 720-2012/MINSA. Dated 29-08-12, Approve 'Modify the
Regulations of Pharmaceutical Establishments, approved by D.S. No. 014-2011-
SA.
Ministerial Resolution No. 1240-2004/MINSA. Approve 'The National Policy of'
Medications.
Ministerial Resolution No. 013-2009/MINSA Approves Manual of Good Practices
of Dispensation.
Ministerial Resolution No. 585-99-SA/DM DELN 27.11.99 - Manual of Good Practices
Storage Practices for Pharmaceutical and Related Products.
Mandatory Health Notification (MHN) (art.6, Decision 516., and art.2, Decision
706).
List of Pharmaceutical Products for sale without a Prescription in
Pharmaceutical Establishments.

4. DEFINITIONS

Not applicable in the present procedure.

5. GENERAL CONDITIONS

The development of staff competencies is carried out through the processes of

induction, training, and retraining.
Attendance of staff at training sessions is mandatory.
 POES002 PAGE 2 of 3

The owner and the Technical Director of the Botca identify the needs of the
staff training.
Based on the identified needs, the training plan is developed.
It will include basic and critical aspects for the performance of your functions.

6. DEVELOPMENT OF THE PROCEDURE

6.1 Staff training will be conducted based on a written program

training, prepared by the Technical Director, which must be approved by the
owner.

6.2 The training program should include topics that are related to the
technical processes of reception, storage, dispensing and/or sale of the Products
Pharmaceuticals and Sanitary Products, safety regulations and preventive maintenance.

6.3 The Technical Director must keep a record of each training conducted with the annexes.
corresponding (memory aid, slides and/or handouts, evaluation tests
properly qualified and list of attendees).

6.4 Each speaker or exhibitor must prepare the following work material:
. Slides and/or Handouts
. Evaluation sheet
. List of attendees

6.5 The evaluation will be based on a grading of the questions by assigning a score to them.
range 0 to 20.

The rating considers the following results:

From 11 to 13: Regular

From the 14th to the 16th: Good

From the 17th to the 20th: Excellent

6.6 The evaluation will be approved with a rating of Good or Excellent; otherwise,
the staff will have to review again and at a later date they will have the opportunity for a
second evaluation.

6.7 If the personnel fail, they will not be able to work in the activities involved in the
training, so your case will be communicated to General Management in written form in order to
that I took the appropriate corrective measures.

7. INDUCTION OF NEW PERSONNEL

By establishment policy, all personnel hired to perform functions in the

BOTICA JAZMIN will be required to undergo a mandatory 1-day induction process.
skilled to understand the following phases:

Knowledge of the areas of the botca:

2. Presentation of the staff of the botca and the positions they hold.
 3. Instruction on occupational safety and personal hygiene rules.

POES 002 PAGE 3 of 3

4. Delivery of functions and procedures to be executed.

Upon completion of the induction process, the staff joins as personnel
permanent and will be considered in all aspects related to training and/or
scheduled training.

8. ANNEX

ANNEX 1 Annual Training Program PROG.-001

ANNEX 2 Attendance Sheet for Training Courses REG-001

ANNEX 3 Training Format for NEW Staff FORM-002

9. CERTIFICATE OF DISTRIBUTION AND ACCEPTABILITY OF THE POES

With my signature, I attest that on the date indicated, I have received, read, and understood the
present POES.

First and Last Names Company Date

1.

2.

3.

4.

5.
POES-N-003 PAGE 1 of 7

RECEIPT OF PHARMACEUTICAL PRODUCTS

MEDICAL DEVICES AND HEALTH PRODUCTS (PF, DM AND PS)

1. OBJECTIVES:

Establish the procedure to follow for the reception of pharmaceutical products.

Medical devices and health products.

2. SCOPE

Professional and technical personnel working in the botca.

3.FREQUENCY

Each time the Pharmaceutical Products, Medical Devices, and Products are received
Sanitary facilities.

4. LEGAL BASIS

Law No. 26842 - General Health Law

Law No. 29459 Law on Pharmaceutical Products, Medical Devices, and Sanitary Products.

Supreme Decree No. 023-2001-SA. Regulation on Psychotropic Drugs and others

substances subject to Health Oversight.

Supreme Decree No. 014-2011-SA Approves Regulations for Pharmaceutical Establishments

and its amendment (Supreme Decree No. 002-2012/SA).

Supreme Decree No. 016-2011-SA - Approves Regulations for Registration, Control, and Surveillance
Health Regulations for Pharmaceutical Products, Medical Devices, and Sanitary Products, and their
modification (Supreme Decree No. 002-2012/SA).
Ministerial Resolution No. 720-2012/ MINSA. Dated 29-08-12, Approve the modification of
Regulation of Pharmaceutical Establishments, approved by D.S N°014-2011-SA.

Ministerial Resolution No. 585-99-SA/DM of November 27, 1999 - Good Practices Manual
Storage of Pharmaceutical Products and Related Items.

Ministerial Resolution No. 013-2009/MINSA Approves Manual of Good Practices

Dispensation.

5. DEFINITIONS

Reception Manager: Person in charge of receiving the products.

which is under the responsibility of the Technical Director of the Botca.

-Immediate or primary packaging. - Packaging in which the product is placed directly.

the finished pharmaceutical or cosmetic form.

Intermediate or secondary packaging - Final packaging or container within which the

primary packaging.
 POES- N003 PAGE 2 of 7

Counterfeit product. - Pharmaceutical product, medical device or health product

manufactured improperly in a deliberate and fraudulent manner regarding its
identity or its origin. It can include products with the correct ingredients or with the
incorrect ingredients, without active pharmaceutical ingredients (APIs), with ingredients
active pharmaceuticals (8IFAs) insufficient or incorrect or with falsified packaging or insert.

Contaminated product or device: It is one that contains microorganisms, parasites.

strange materials, substances or others foreign to their authorized elements in the registry
sanitary, potentially harmful to health.

Altered product or device: It is one that has lost the quality and effectiveness of its effects.
due to deficiencies in its storage, transportation, preservation, or any other cause
after its elaboration.

Adulterated product or device: It is one whose composition specifications, characteristics

or others included in the respective health registration or mandatory health notification have
modified with the purpose of concealing a change, or of extracting or adding total or
partially some of the ingredients or components.

Non-conformity: Failure to comply with an officially established requirement.

Health Observation: It is the detection of an irregular fact prior to perception, analysis, and
identification, which is carried out during the evaluation process and is supported by
objective evidence of the finding.

Poor state of conservation: Products or devices whose immediate or ultimate packaging is

they are found deteriorated, mistreated, broken, or in inadequate conditions of conservation.
6. POLICIES AND REGULATIONS OF THE PHARMACEUTICAL ESTABLISHMENT.

The purchase and acquisition of products must be supported by a Shipping Guide and/or
Invoice: In the case of Guide or Invoice, it must be issued in the name of the establishment.
pharmacist BOTICA MAXI with Ruc number: 10096649733, Business Name: ATAUSINCHI
TINTAYA EFRAIN, located at av. Pedro Beltran street 23 Ventanilla Callao

7 SPECIFIC PROVISIONS:

In case of a discrepancy or non-compliance during reception, it must be noted.

certificate of the fact, for which a document will be signed detailing the observations of the
NO conformity; to make the appropriate claims to the supplier and/or rectify the
found.

The Technical Director of Botca, according to their review, will grant their approval or rejection to
the reception of pharmaceutical products, medical devices and/or sanitary products.

The Technical Director of the Botca will give the approval V °B ° to the received products, which
these meet the required specifications and characteristics.

SONG-003 PAGE 3 of 7
RECEPTION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND PRODUCTS
SANITARY (PF, DM AND PS)

If approved, the product is suitable to be placed on the shelves of the area of

storage.

If the products are REJECTED by the Technical Director of the Botca, the product must be
returned to the supplier; and/or will be received in custody by placing them in the Area of
Rejected Products - Low. Recording the fact.

All packaging or received product must be placed on pallets in perfect condition.

state and in a safe place that does not obstruct the free movement of personnel inside the
local.

8. DEVELOPMENT OF THE PROCEDURE

8.1 ENTRY OF PRODUCTS

When the product arrives, the Technical Director will receive the purchase orders and verify them.
that the documentation is complete and in accordance with the shipping guide.

Record the date and time of arrival of the transporter and/or supplier.

8.2 OF DOCUMENTARY VERIFICATION

The Pharmacy Technical staff in charge of receiving will verify the quantity of the
products received with the invoice or delivery guide and the stamp as a sign of conformity.
If the document verification is not in accordance due to the absence of some or all of them
documents, the Q.F. Technical Director receives the products as custodial quality for this purpose
You should consider the reliability of the supplier.

If the receipt is approved, the pharmacy technician counts the packages and places them in the area.
of Rejected Products-Low, sign the compliance record only if it includes the number
of boxes that are delivered, but if the product and the quantity are listed, it is no longer signed.

The D.T will request the supplier to regularize the documents as soon as possible.
observed.

If the documentation is in order, it will verify that the documents submitted by the
supplier matches the document and with the requirement or purchase order of the Botca,
to verify the following information:

a- Product Name

b- Concentration and pharmaceutical form when applicable

c- Manufacturer

d- Lot number

e-Presentation
 POES003 PAGE 4 of 7

RECEPTION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES, AND SANITARY PRODUCTS (PP, MD, AND SP)

f- Expiration date

g- Quantity requested

h- Other documents and information established in the purchase order

If the documentation is not compliant, the product is not received and its regularization is requested from the supplier.

If the documentation is correct and complete, the verification of the load and quantities proceeds.
products received

8.3 OF THE VERIFICATION

The Technical Director proceeds to open the box and checks that the products match what is stated in the documents.
received, if they do not match, do not accept and inform the supplier of this fact for their return.

If it is approved, the Technical Director will supervise the unloading of the products in the reception area and review that the
packaging is in good condition, clean, not wrinkled, damp, and not opened.

-If there are missing and/or damaged items in the packaging, the product is not received and the supplier is informed of this fact.

The Technical Director reviews the external characteristics of the products and, when appropriate, the
organoleptic analysis of the same.

During the reception, the inspection to be carried out will include the external characteristics of the products, checking:

Packaging

Number of Packages

That it is not open and/or violated.

That it is clean

It should be properly labeled

That it is not wrinkled

That it is not damp

That there are no visible signs of deterioration

That it is complete

Packaging

a) Immediate and direct packaging, the following must be verified:

- That it is clean.
- To be properly labeled.
- It should not be wrinkled.
- That it is not humid.
- That it is not broken.
 POES003 PAGE 5 of 7

RECEPTION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND PRODUCTS

SANITARY (PF, DM AND PS)
That it does not show stains or signs of deterioration.

That the labeling information (product specification) can be read

in the Spanish language.

b) On the immediate packaging:

That no stains or foreign bodies are observed.
That there are no cracks, fissures, breaks, or perforations.
That the closure or seal is secure and that when there is a security band, it is present.
Intact.
That they are not deformed.
That corresponds to the product requirements in case of special conditions
(if it was requested in the order).

c) Likewise, it will confront the product information regarding:

Product name or description

Code (if applicable)

. Batch number

. Manufacturing date (if applicable)

Labeled

They must be legible and indelible; in the case of labels, they must be well adhered to the
container

And in them review:

- Product Name
- Concentration
- Pharmaceutical form
- Form of presentation
- Batch number
- Expiration date
- Health Registration
- Identification of the manufacturer and the importer when applicable
- Content of the products (when relevant). As long as there is no risk of
alteration of the same.
- Storage conditions

Organoleptic Analysis (when applicable, that is, whenever there is no risk of

alteration

Of the same.

NON-STERILE LIQUIDS (syrups, elixirs, suspensions, emulsions, solutions, and drops)

Product homogeneity;
Uniformity of content.