Company Name:

Document No: SOP/QAC/ HO-01

የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ
Ethiopian Pharmaceuticals Supply Agency
Title:
Effective date : 13/09/19
SOP for Control of Documents
Rev. No.: 0 Page 1 of 15

CONTENTS PAGE FOR DOCUMENT CONTROL USE

ONLY
1. INTRODUCTION 2
2. PURPOSE 2
3. SCOPE 2

4. RESPONSIBILITY 2

5. PROCEDURE 3

6. FORMS 15

7. AMENDMENT HISTORY 15

PREPARED BY APPROVED BY

Name: QA team Name:

Signature: Date: Signature: Date:

 Page 2 of 15

1. INTRODUCTION

Good Documentation is an essential part of the quality management system and should
also exist for all aspects of GSP and GDP. This document control procedure provides a
road map in establishing all types of documents at EPSA including the medium in which
it is contained.
For the purpose of this document in addition to the definitions given in ISO 9000:2015,
the following definitions apply.

 Document: A Series of instructions or requirements that provides guidance/

directions for performing work. A document can be in the form of hard copy,
film, sample drawing, and computer program (soft copy).
 Standard Operating Procedure; An authorized written procedure giving
instructions for performing operations not necessarily specific to a given
product or material.

Note: Forms are documents.

Abbreviations

FLW: Flowchart
DG: Director General
DDGS፡ Deputy Director General for System strengthening
DC: Documentation Center
DO: Document Officer
OF: Operational Forms
QMS: Quality Management System
DD: Directorate Director
SOP: Standard Operating Procedure
DM: Department Managers
EPSA: Ethiopian Pharmaceutical Supply Agency
GSP: Good Storage Practice
GDP: Good Distribution Practice

2. PURPOSE
The purpose of this procedure is to define the methods in preparing and introducing
new documents, to make changes on the existing documents and to control documents
of external origin.

3. SCOPE
This procedure is applicable to all documents of EPSA including those of external
origins.

4. Responsibility
QA head is responsible for effective implementation of this SOP across all functions
and directorates of EPSA
እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ
SOP for Control of Documents,
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 Page 3 of 15

5. PROCEDURE

5.1 Process flowchart

INPUT PROCESS OUTPUT RESPONSIBILTY
1, Requests 1. Registered Request for 1, Any EPSA employee
document
creation/change

2, Registered request for 2, Approved request/ 2, DDGS for documents

document Rejected request applicable to more than one
creation/change, 3a, Document rejection function, DD’s accountable
Master list of documents notification notes to DG in their area of
responsibilities

3b. Approved request, 3b, Registered document 3a,3b, DDGS for

Employee skill register request, Assigned documents more than one
Matrix document writer function, DD’s in their
area of responsibilities

4, Registered document 4, Verified work 4, assigned document

request category writer

5, Assigned document 5, DO
5, Verified work category
number

6, Draft Document 6, Assigned document

6, Document and forms writer
template

7, Review notes 7, DDGS for documents

7, Draft document more than one function,
DD’s in their area of
responsibilities

8, Documents and Forms 8, Approved 8, DDGS for documents

Template document/Re-work order more than one function,
DD’s in their area of
responsibilities

9, Approved document 9, Registered document 9, DO

10, Document receipt 10, DO

10, Registered document
acknowledgement

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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5.2 Description of process steps

FLW Process Steps Description
1 Document creation or change request may be raised by any EPSA employee using OF/QA/HO-01.
2 Documents creation or change request shall be reviewed against master list of documents.
The request shall be reviewed and approved by the designated authorized body before a document is
created or changed.
3a The main reasons for rejection of document creation request may include;
- When there is an existing document for the job in question
- When there is no existing process/ activity to be defined by the proposed document.
- When training is sufficient for the job in question.
Document creation or change request is rejected when the requester fails to provide adequate
justification for the creation or change.
When requests are rejected the reasons for rejection shall be recorded and maintained and notified to
the requester.
3b A Competent person or group of persons shall be assigned to write new documents or make changes
on the existing ones.
4 Additional description is not required
5 The Documentation Officer shall assign document number and shall record the assigned number on
Controlled Documents Master List, OF/QA/HO-05.
6 a) The document writer shall prepare the document considering the level of education of the
employees who will be using the document and the risks and criticality of the process to be
defined by the document.
b) Document language shall be determined in advance.
c) The document writer shall organize the document in accordance with Documents Template,
OF/QA/HO-04.
7 The document review shall include:
a) Clarity
b) Completeness
c) Complying with the documents and form templates
d) Legibility
e) ISO 9001 requirements
8 Additional description is not required
9 The Documentation Officer:
a) Shall make required copies of document for issuing;
b) Shall retain and file the original copy of documents (approved but without stamp);
c) Using a rubber stump shall indicate on all copied documents to be distributed ( except
forms), " Registration Number" and " Copy Number";
d) Shall register:
 Documents created or changed by EPSA on “Controlled Documents Master List, OF/QA/HO-
05”.
 Documents of External Origin on “ External Documents Master List, OF/QA/HO-07”;
10  The Document Officer shall issue documents to the locations where they are needed using
Documents Release Note Form, OF/QA/HO-03.
 In the case of documents change, the old (obsolete) documents shall be returned to the

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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 Page 5 of 15

Documentation Center, and the DO shall register on obsolete documents master list.
 Recipient of the document shall acknowledge by signing on the Documents Release Note Form
returning it to the DC.

5.3 Additional description to the process steps

5.3.1 Document coding system
The sequence of document coding runs as follow.
1st: DD: Two or three letters for Document Code
2nd: XX: Two or three letters code for directorates identification
3rd:YY: Location of the document; HO for Head Office and BR for Branch
4th : ZZ: Document Serial number with two digits

Example;

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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5.3.2 Contents of SOP’s

The general format for standard operating procedures is as follows.
5.3.2.1 Contents
Main contents of the documents with its page number shall be described.

5.3.2.1 Introduction
Gives a brief overview of the document including definitions and any abbreviations
associated with the document

5.3.2.2 Purpose
Describe the main purpose of the procedure.
5.3.2.3 Scope
Describe the area or subject where the procedure is applicable.
5.3.2.4 Responsibility
Describe the overall owner of the process.
5.3.2.5 Procedure
Describe the process steps clearly and adequately.
5.3.2.6 Forms
List the records that must be generated and retained to demonstrate that the requirements of
the procedure have been fulfilled.

5.3.2.7 Amendment history

Describes major changes during revision of documents, person/s involved in the revision
process as well as effective date of the document

5.3.3 General page layout

Format typographical specifications
The following specifications are all typographical matter:
Fonts:
a) Font style – Times New Roman
b) Font size
 Document Title - 14 point, Title case and bold
 Document number - 11 point, and normal;
 Issue number – 10 point, and normal;
 Effective date-10 point, and numerical (date/month/year)
 Body Text-font size as appropriate but not less than 7 points, and normal or
bold.
c) General format for developing SOP’s, forms and work instructions are presented
in the template below.

5.3.4 SOP’s template

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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 Page 7 of 15

Company Name:
Document No: SOP/XX/ YY-ZZ
የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ
Ethiopian Pharmaceuticals Supply
Agency
Title: Effective date :

Rev. No.: 0 Page x of y

CONTENTS PAGE
1. INTRODUCTION
2. PURPOSE
3. SCOPE
4. RESPONSIBILITY
5. PROCEDURE
6. FORMS
7. AMENDMENT HISTORY
FOR DOCUMENT CONTROL USE
ONLY

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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 Page 8 of 15

1. INTRODUCTION

2. PURPOSE

3. SCOPE

4. RESPONSIBILITY

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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 Page 9 of 15

5. PROCEDURE
5.1 Process flowchart
INPUT PROCESS OUTPUT RESPONSIBILITY
1, 1,
1,

2, 2,
2,

3, 3,
3, 4a, 4a,
4a,

4b, 4b,
4b,

5,
5, 5,

6,
6, 6,

7, 7, 7,

5.2 Description of process steps

FLW Process Steps Description
1

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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4a

4b

5.3 Additional description to process steps

6. FORMS
Document Number Document Title

7. AMENDMENT HISTORY

AMENDMENT HISTORY
Issue No. Description of Change Originator Effective Date

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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5.3.5 Forms Template

Company Name:
Document No: OF/XX/ YY-ZZ
የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ
Ethiopian Pharmaceuticals Supply Agency
Title: Effective date :

Rev. No.: 0 Page x of y

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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Company Name:
Document No: WI/XX/ YY-Z
የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ
Ethiopian Pharmaceuticals Supply Agency Place:: HO or Branch
Title: Effective date :

Rev. No.: 0 Page x of y

5.3.6 Work Instructions Template

Step by step activities of a specific operation;

1.
2.
3.
4.
5.

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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5.3.7 Control of external documents

The Document Officer shall receive and register all external documents including legal
requirements and produce sufficient copies of the external documents and issue to the
locations where they are needed for implementation. The documents shall be identified with
rubber stamp labeled with "Registration Number" “Document Number“, and " Copy
Number" .

5.3.8 All Document control system shall address the following requirements

a) All documents prepared by EPSA shall contain in the footer Document Title,
Identification No., Rev. No., and Effective date and the reminder “ Please make sure that
this is the correct issue before use” including the Amharic Version.
b) New documents and changes to existing documents shall be reviewed and approved for
adequacy and completeness by the responsible authorized person before release for
implementation.
c) All documents shall be legible, dated, readily identifiable with unique numbers, titles, and
issue numbers, and maintained in an orderly manner.
d) Documents shall be readily available to all users within EPSA.
e) External documents shall be properly identified and distributed for users and removed
from all location when they become obsolete. A separate master list shall also be
prepared and maintained by the Documentation Center.
f) The latest approved manuals, policies, regulations and directives shall be properly
identified and available to users.
g) Forms associated with QMS documentation shall be controlled. Each form shall be
uniquely identified indicating the latest approved version.
h) All documents shall be reviewed every two years by process owners and updated as
necessary in accordance with document change control system.

5.3.9 Documents Control Identification Template

For Controlled Documents

(Blue Stamp)

CONTROLLED
QMS DOCUMENTS
Registration No.

Copy No.

Date of Issue

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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For documents of external origin

(Blue Stamp)

EXTERNAL ORIGIN
CONTROLLED
QMS DOCUMENTS
Registration No.
Document No.
Copy No.
Date of Issue:

For Uncontrolled Documents

(Blue Stamp)

QMS DOCUMENTS

UNCONTROLLED COPY

For Obsolete Documents

(Red Stamp)

QMS DOCUMENTS

OBSOLETE
(Font size 20)

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
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6. Forms

The following forms are used for the implementation of this SOP.

Document Document Title

Number
OF/QAC/01 Document Creation/Change and External Documents
Adoption Request Form
OF/QAC/02 Document Approval Request Form
OF/QAC/03 Document Release Note Form
OF/QAC/04 Document Template
OF/QAC/05 Controlled Documents Master List
OF/QAC/06 Controlled Documents Distribution Master List
OF/QAC/07 External Documents Master List
OF/QAC08 Obsolete Documents Master List

The Documentation Center has the responsibility to retain the following records.
 Document creation / change/external documents adoption request
 Document review and approval notes
 Documents Distribution List
 Master List of Documents, Forms and Documents of External Origin

7. AMENDMENT HISTORY

AMENDMENT HISTORY
Rev. No. Description of Change Originator Effective Date
0 Initial Release QMS Task Force 13/09/19

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

SOP for Control of Documents,
Please make sure that this is the correct issue before use SOP/QAC/ HO-01, 0, 13/09/2019