Standard Operating Procedure

Title: Preparation, Maintenance and Change Control of Master Documents

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EHS Statement
There is no EHS impact.

Table of Contents
1. A New Product ........................................................................................................................................ 2
2. List of Documents in the Master file:....................................................................................................... 3
3. Key Personnel and Responsibilities........................................................................................................ 3
4. Documentation Database........................................................................................................................ 3
5. Master File .............................................................................................................................................. 3
6. Preparation and Change to Master Documents ..................................................................................... 4
7. Category and Examples of Changes ...................................................................................................... 7
8. Master Document Review Frequency..................................................................................................... 8
9. Satellite Document Files ......................................................................................................................... 8
10. Appendix 1 - Flow Chart for Preparation and Change of Master Documents ........................................ 9
11. Appendix 2 - Flowchart for Distribution of Master Documents.............................................................. 10
12. Summary of Changes ........................................................................................................................... 10

Procedure
1. A New Product
A new product normally originates from Supply Chain.
The first step towards the manufacture of any new product must be the preparation and provision of
a local Master File.

This Master File may be developed from Technical Documents, information from the Company from
which the data was obtained, or from Local Development work.

The information contained in the Master File is the PRIME SOURCE of information for both new
product applications to the Regulatory bodies and/or export regulatory authorities and for preparing
local manufacturing documents.

1.1. Each Master File defines critical processes and must contain information in the following
sections:
a) Product Formulation
b) Method of Manufacture,
c) Raw Material Descriptions, Specifications and Test Method
d) Product Specifications (In-process, Release, Expiry, Stability) and Test Method
e) Analytical Methods - Finished Product
f) Description and Specification of Packaging Components
g) Stability Data
h) Technical Reports and other relevant data.

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Standard Operating Procedure
Title: Preparation, Maintenance and Change Control of Master Documents
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5.3. For new components, (Packaging and Raw Materials), their descriptions and Code Numbers
are allocated by the QA Department.

5.4. Where a change needs to be made to an In-house Master File document, which is of an
urgent nature, then the change may be made directly on to the original and authorised by the
Technical Service Manager or delegate. The circumstances under which these changes can
occur are restricted to changes that do NOT affect the registered details and those which are
typographical errors. All in-house Technical documentation changes must be actioned
through the Technical Service Department.

5.5. Documents are identified using a unique number. The number consists of a prefix, a core
number and suffix, e.g. S-XXX-YY.A.
Prefix ID
The prefix ID identifies the document type as listed in SOP QMS-010
Core Number
This number is the unique number taken from the product code number. If a number of
product codes use the same document, then the core number is the lowest of the associated
code numbers.
Suffix
Suffix is alphanumerical and consists of the year and the version number. The version
number is alphabetical, e.g. Second version modified in year 2001 will be written as 01.B
Updating documents
The prefix and core number remain the same and the suffix changes in accordance with the
year it was modified and the number of times it has been modified within that year. The core
number may change where a number of product codes are represented by the document
and the lowest core number product becomes obsolete.

6. Preparation and Change to Master Documents

6.1. Reason for new or revision to Documents
New document requests usually result from the introduction of new product, new material
(ingredient/ components), and new process or procedure or where a need has been identified to a
gap with existing documents.
Revision to existing documents usually results from specification or process change or corrections.
Revision of can be initiated by way of Master Document Change Control Form (Form-365)

Preparation of new Master Document

6.2.
6.2.1. A request to Create/Cancel Controlled Document Form (Form-505) can be initiated

by anyone in the manufacturing. The Technical Service Staff receives the request
with all relevant information attached for the creation of a new document. A
document number will be assigned for the new document and place in the Draft
folder in the Master document database.

6.2.2. The request Is then evaluated for the following

▪ Validity of the request
▪ Possible regulatory impact on all Markets affected by the proposed change
▪ Impact to documentation policy and requirement for prior management
approval.
▪ Impact to related master documents and Bill of materials.

6.2.3. Once the evaluation has been completed the request is either rejected, returned to
the initiator or processed for new master file.
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Standard Operating Procedure
Title: Preparation, Maintenance and Change Control of Master Documents
______________________________________________________________________________________
6.3.16. When signed, make appropriate number of official masters as specified in the
following table and stamped with “This is an Official Master if Stamp Is in Red” sign
and date. Distribute the authorised copies in the satellite files of relevant
departments according to section 4 of SOP QMS-010.

6.3.17. Remove the original electronic version in the Superseded folder from Live folder of
the database. Replace it with the changed file with appropriate version number from
Draft folder.

6.3.18. Update master document list. Retrieve the hard superseded copy from the master
document file, stamp with “Superseded” and place it in the superseded master
document file.

6.3.19. File one changed and approved hard copy in the master document file.

7. Category and Examples of Changes

Specification change Any change to a specification, BOM or data sets. This includes but is not limited
to:
⮚ Raw materials, Packaging components, In process testing, Packaged
product and equipment specifications
⮚ BOM for bulk and finished products
⮚ Data sets for starting materials or finished products
Analytical method Any change to or deletion of a testing procedure or inclusion of a reduced testing
change schedule. This includes but not limited to:
⮚ Raw materials, packaging components, in process products, packaged
products and calibration tests
Raw materials ⮚ Any change to a raw material supplier, manufacturing site, manufacturing
change process, mode of transport or storage of containers.
Packaging Any change other than artwork to a packaging component. This includes but Is
components not limited to:
⮚ Bottles, caps, tubes, foils etc (e.g. thickness, materials, dimensions)
Manufacturing Any change to the processing procedure. This includes but is not limited to:
process change
⮚ Manufacturing process (e.g. stirring time, blending time, order of addition
drying time or temperature where variation is not specifically covered in
the manufacturing instructions)
⮚ Packaging process (e.g. cap torque, filling temperature, line set up and
shut down procedure, fill volume, blister seal temperature etc)
⮚ Cleaning process (e.g. time, temperature, method, cleaning agents etc)
⮚ Introduction of a new product to the manufacturing facility.
⮚ Transfer of an in-house manufactured product to an alternate
manufacturing site.
Equipment Any modification or alteration to equipment or the environment where the
/Computer change equipment operates, or the relocation of the equipment from one place to another
or the introduction of new equipments or consumables to existing equipments.
This include but is not limited to:
⮚ Manufacturing equipments (e.g. manufacturing and storage tanks,
blenders, stirrers, compressing machine, drying oven, granulators, fluid
bed dryers, storage hoppers, transfer lines etc)
⮚ Purified water system (e.g. Pumps, valves, dosing mechanism etc)
⮚ Packaging equipment (vision system, capper, labeller, bottle blower,
shrink wrapper, cartonner, case packer etc)
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Standard Operating Procedure
Title: Preparation, Maintenance and Change Control of Master Documents

11. Appendix 2 - Flowchart for Distribution of Master Documents

Approved
Master
Document

Update
Documentation
Database

Master File

Replace
Copies for
Superseded
Satellite Files
Original Document
with Updated Refer to table
Document 6.2.7

File Administrator
File Superseded to replace
Superseded copy
Original with new
into relevant
Superseded
Document Folder

Return
Superseded copy
to Technical
Service
Department

Technical to
Destroy
superseded copy

12. Summary of Changes

Version # Revision History
QMS-030 New

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