NUMBER PPL-POE-001

STANDARD OPERATING PROCEDURE

VERSION: 1.0

EFFECT DATE: 19/01/2014

END OF VALIDITY DATE 19/01/2015 NEW PAGE 1 of 8
Prepared by: Javier Rusca Reviewed by: Lisha Yangali Reviewed by: Susana Chuquillanqui Approved by: Luciano Brumel
FUNCTION: Engineering Analyst FUNCTION: Head of FUNCTION: Technical Director FUNCTION: General Manager
Engineering

Aim

Provide guidelines for the preparation of Standard Operating Procedures (SOP) to be

developed and applied both in the general warehouse, as well as in the PPL Logistics
Drugstore, taking into account the guidelines referring to the manual of Good Storage
Practices for Pharmaceutical and Related Products.

PPL Logistics Drugstore Quality Policy

The PPL Logistics Drugstore is a company dedicated to the storage of Health Products aimed
at the national market, whose policy is to provide an efficient service, through continuous
improvement in the implementation and maintenance of a system, which guarantees
compliance with Good Practices. of Storage.

Scope

Applies to the Technical Management and the operations area of both the general warehouse
and the Drug Store of PPL Logistics.

Procedure Versions

Version Date Version Prepared by Post

19/01/2014 1.0 Javier Rusca Engineering Analyst

References

 Law No. 29459 – Law on Pharmaceutical Products, Medical Devices and Health
Products.
 Supreme Decree No. 014-11-SA “Regulation of Pharmaceutical Establishments”.
 Supreme Decree No. 016-11-SA “Regulation for the Registration, Control and Health
Surveillance of Pharmaceutical Products, Medical Devices and Health Products.
 Ministerial Resolution No. 585-99-SA/DM “Manual of Good Storage Practices for
Pharmaceutical and Related Products”

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Mission

We create customized logistics solutions for our clients, exceeding their expectations and
achieving efficiency in the Supply Chain based on 4 principles:

1. Time
2. Accuracy
3. Quality
4. Cost

Vision

That clients trust PPL Logistics as a strategic partner for their logistics operation, leading the
industry in terms of quality, innovation and technology, generating added value with dynamic
solutions and highly motivated human talent.

Values:

- Our people are the most important thing.

- Constant innovation.
- Attitude and passion.
- Teamwork.
- Honesty and respect.

Responsible and Responsibilities

Engineering Analyst:

- Prepares standard operating procedures based on established criteria, client request

and information gathering.

Head of Engineering:

- Reviews the procedures developed and approves them for approval.

Technical director:

- Reviews the procedures developed based on their adaptation to the rules and
regulations required by DIGEMID.

General manager:

- Approves the procedures developed and reviewed, giving approval and requiring
compliance.

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Definition of Terms (Alphabetical Order)

- Scope: Defines what or who the procedure under development applies to.
- Approved by: Record the name and signature of the person authorizing the
implementation of the Document.
- Code: Alpha numeric notation defined according to the following example:
o PPL POE-001
 PPL is the acronym of the commercial name of the Peruvian Pacific Line
drugstore.
 SOP stands for Standard Operating Procedure.
 The 3 digits after the middle dash indicate the consecutive number of the
Standard Operating Procedure.
 For different reasons, the original POE may undergo modifications. In
that sense, when there is a need to issue a new version of the SOP, a
forward slash followed by two digits is added to the original notation that
indicate the correlative version. Example PPL POE-001/01
 Administration of procedure numbers is the responsibility of the
engineering analyst.
- Definitions of Terms: In some cases it is necessary to clearly and precisely define the
meaning of some words, acronyms or terms.
- Procedure Development: Defines in a sequential and logical manner the steps to
follow in a specific process.
- Prepared by: Record the name, position and signature of the person preparing the
document.
- Effective Date: Refers to the date on which the formatted document is issued, for
example: 09/01/2013. It indicates that the POE was issued on September 1, 2013.
- End of Effective Date: Describes the day, month and year in which the next review of
the POE will be carried out.
- Flowchart: It is the diagramming of the procedure, this applies only to direct
processes.
- Formats and/or Annexes: Formats or other registration documents, complementary
to the procedure.
- Legal Framework or References: Any document related and/or complementary to the
procedure.
- Objective: Describes the purpose or reasons why the procedure is developed.
- Page: Registers the pages of the document.
- Direct Processes: These are those processes that are operationally linked and are
part of the basic production chain of the final product or service.

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- Indirect Processes: These are those complementary processes that generate greater
value, guide and protect inputs within the production process.
- Persons in charge and Responsibilities: Lists the people in charge of applying and
ensuring that the procedure is applied.
- Reviewed by: Record the name(s) and signature(s) of the person(s) reviewing the
document.
- Historical Review: Briefly describes in chronological sequence the change in the
reason for this document.
- Replaces: Refers to the previous version of the same document, if it is the first edition,
write “New”.
- Title: Text that indicates in summary form what the document is about.
- Versions: Defines who created each existing version of the procedure.

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Procedure Development

Creation of New POE:

1. The engineering analyst will write a first draft of the SOP considering the steps that must
be carried out to meet the objective of the procedure.

2. The engineering analyst will call a meeting with those responsible for the area to which the
procedure in question refers (at least the senior position of the respective area and the
head of engineering must attend).

3. The engineering analyst reads the entire procedure aloud at the meeting.
3.1. If those responsible for the area have doubts, the engineering analyst with the
support of the engineering manager will resolve them.
3.2. If there are observations or suggestions for the inclusion/exclusion of any step,
after discussing these observations, the result will be noted by the engineering
analyst in the minutes of the meeting.

4. The engineering analyst will generate a training record where all meeting participants must
sign, which will serve as support for reading the second draft.

5. The engineering analyst will edit the first draft with the observations of the area,
generating a second draft, which will be delivered to the Technical Director for review.

6. The Technical Director will review that the procedure complies with the rules and
regulations required by DIGEMID.
6.1. If there is a step that violates a rule or regulation, it must be corrected or, if
unnecessary, excluded.
6.2. If a step is necessary to comply with a rule or regulation, it must be included.

7. The engineering analyst will edit the second draft with the Technical Director's
observations, generating a third and final draft.

8. The engineering analyst will call a final meeting where the head of engineering, the
Technical Director, those responsible for the area will attend (at least the highest position
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in the respective area), a final review of the modified points will be given and a report will
be issued. reading record of the latest draft, serving as support for approval of the
procedure, which will finally be delivered to the General Manager to obtain his approval
signature and make the procedure official.

Distribution of copies of the SOP:

1. The engineering analyst is responsible for maintaining the original copy of the SOP;
any copy that is distributed must have a “CONTROLLED COPY” seal.

SOP Review:

1. Thirty (30) days before the end of validity date, the engineering analyst will call the
procedure review meeting, this will serve so that those who will attend can be prepared for
the meeting.
1.1. If the date falls on a non-working day or holiday, the meeting will be called for
the next working day.
1.2. At a minimum, the head of engineering, the Technical Director and the highest
position in the respective area must attend.

2. On the day of the procedure review meeting, the engineering analyst will read the
procedure aloud.
2.1. In the event of doubts or observations of changes or new requests from the
client, these will be resolved and/or discussed, and the procedure will be
modified at that very moment.
2.2. In the event that the modification cannot be made at that same moment because
it requires coordination with areas or positions not present, a new procedure
review date will be given.

3. Once the review of the document is completed, a procedure review record will be
delivered where all participants in the meeting must sign, which will serve as support for
approval of the procedure. On this same sheet “REVISED” will be stamped and the new
effective date will be written.

4. The engineering analyst will then give the procedure to the General to obtain his signature
of approval and make the procedure official.

Modification and Withdrawal:

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1. The modification of the procedure can occur for 2 reasons:

1.1. There is a notification of the inclusion, exclusion or modification of a new step that will
affect the respective process.
1.2. The review date is reached and modification is found necessary.

2. When it is modified and/or canceled, the engineering analyst must place a “REPLACED”
and/or “VOID” stamp (both in red), as appropriate, and transfer it to the historical file.

3. The controlled copies will be collected and destroyed by the engineering analyst and
exchanged for the controlled copy of the new version of the SOP.

POE format:

1. As an engineering analyst, when preparing/reviewing/modifying the SOP, you must ensure

that the format includes the following:
1.1. Font Type: Arial
1.2. Font Size: 12 points for general text, 8 points for header data.
1.3. Line spacing: Single (simple), 1 space (0.48cm)
1.4. The procedure header must present the following fields:
1.4.1. Number: PPL-POE-000.
1.4.2. Version: AB
1.4.2.1. Each change in A represents a version with creation or elimination of
steps in the development of the procedure.
1.4.2.2. Each change in B represents an ordering of steps or change of words
(terms) in the development of the procedure, as well as general
changes (including creation or elimination of steps) in the other fields.
1.4.3. Effective Date: The date the procedure was approved.
1.4.4. End of Validity Date: The date on which the annual review must be done.
1.4.5. Title: The title of the procedure.
1.4.6. Replaces: The code and version of the procedure it replaces.
1.4.7. Page: X/Y, where “X” is the current page and “Y” is the total pages.

1.4.8. Signatures of those responsible for the preparation, review and approval.
Considering that this part is only necessary on the first page of the SOP.
1.4.8.1. Prepared by: The name, position and signature of the person who
prepared it.
1.4.8.2. Reviewed by: The name, position and signature of the person(s) who
reviewed it.

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1.4.8.3. Approved by: The name, position and signature of the person who
approved it.

2. The text sequence will be as follows, as applicable.

2.1. Aim
2.2. Scope
2.3. Versions
2.4. Legal Framework or References
2.5. Responsible and Responsibilities
2.6. Definition of Terms (If any)
2.7. Process Diagram (If it is a continuous procedure)
2.8. Procedure Development
2.9. Historical Review (If any)
2.10. Formats and/or Annexes (If any)

Formats and/or Annexes

None.

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