QMS-030 Preparation, Maintenance and Change Control of Master Documents

Document Owner

Technical Service Manager

Affected Parties

All Technical/QA/Laboratory/Regulatory Department personnel involve in creating, updating and approving Master files documents.

Purpose

To describe the preparation and responsibilities pertaining to Master Files, Technical SOP’s, Specifications, Control Methods and Production Documents.

Scope

This SOP is to provide instruction for the preparation and authorization of Technical documentation residing in the Master Files.

Definition

Related Documents

EHS Statement

There is no EHS impact.

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.

2.            List of Documents in the Master file:

3.            Key Personnel and Responsibilities

The Master File documents are normally prepared by the Technical Service Department with the assistance given for Control Methods, Raw Material Specifications-Test Report, Finished goods Specification-Test Report and Stability Specifications from the Laboratory. The Technical Service Department is responsible for ensuring that testing methods have been properly validated, and that the associated report has been approved, before being incorporated into respective control methods and specifications. The documents are then authorized by responsible persons as listed in the SOP QMS-010.

4.            Documentation Database

The Documentation Database is used to facilitate creation, control, maintenance and tracking of Quality, External, and Master file documents. These are also referred to as “Controlled Documents.”

The Documentation Database is divided into three (3) of areas of control:

a. “Quality Documents-In-house and external” – the area of the Documentation Database which stores data for controlling and maintaining Quality Documentation (SOP QMS-015 and SOP QMS-025).

b. “Quality Audits” – the area of the Documentation Database, which facilitates control of the Quality Audit program including scheduling and auditor assignment.  (See SOP QMS-080)

c. “Master File Documents” – the area of the Documentation Database which stores data for controlling and maintaining Master file which is comprised of both Technical and quality documents needed for manufacturing a product (covered in this SOP).

See SOP QMS-010 for the structure of the Document Database.

The Quality Documents and Quality Audit section of the database is maintained by QA and EHS and accessible by all employees.

The Master file documents sections are maintained by Technical Service Departments.

5.            Master File

5.1.         In addition to the documents listed in section two, Master File includes references to official standards, procedures (SOP’s) and Compendia.

5.2.         The Product Description and Product Code number is unique and is allocated by the QA.

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 authorized 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)

6.2.         Preparation of new Master Document

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

a. Validity of the request

b. Possible regulatory impact on all Markets affected by the proposed change

c. Impact to documentation policy and requirement for prior management approval.

d. 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.

6.2.4.     Open template located in the template folder of the database. Prepare new document with the history page.

6.2.5.     Circulate document for review and approval. Update in the Status Box of the Database.

6.2.6.     Print the draft document, review comments, and incorporate any additional amendments into the electronic file. Write new status in the status box. Recirculate the final document for the appropriate approval signature according to section 4 of SOP QMS-010.

6.2.7.     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 authorized copies in the satellite files of relevant departments as listed in the table below.

6.2.8.     Update master document list. File the electronic master document in the Live folder of the database.

6.2.9.     File one approved hard copy in the master document file.

6.3.         Changes to Master File Documents

6.3.1.     A request to Master Document Change Control Form (Form-365) can be initiated by anyone in the manufacturing. Technical Service Staff receives the request with all relevant information attached for the change of the document, assigned a change control number in the under review folder of the database.

6.3.2.     Change control numbers are alphanumeric figured allocated using the following format:    ID-XXYY-ZZ

Where, Prefix ID is chosen for the type of master document to be changed

XX is the last two digits of the current year

YY is the month in which the change is initiated

ZZ is the consecutive number of changes for the specified document

6.3.3.     Ensure document number and the change control number does not interchange.

6.3.4.     The request Is then evaluated for the following

a. Validity of the request

b. Possible regulatory impact on all Markets affected by the proposed change

c. Impact to documentation policy and requirement for prior management approval.

d. Impact to related master documents and Bill of materials.

6.3.5.     Once the evaluation has been completed the request is either rejected and returned to the initiator or processed for revision.

6.3.6.     Once the Technical staff has approved the revision to the master document, retrieve the master document from the existing master file and make a copy of the master document and stamped Draft.

6.3.7.     All requested changes are made to this draft copy with a red pen. The electronic version of this document is then located in the draft folder of the database. Make appropriate changes to the draft document.

6.3.8.     Record the revision date and superseded date on the document.

6.3.9.     Record the changes on the history page. The history should include

a. Date of issue of the new document

b. Date of original issue of the new document

c. Reason for revision

d. Master Document Change Control Number

6.3.10.  Circulate the draft document with a copy of the Document Change Control Form. Write the circulation details in the Status Box of the database. The draft is circulated to the signatories according to section 4 of SOP QMS-010.

6.3.11.  Open template located in the template folder of the database. Prepare new document with the history page.

6.3.12.  Circulate document for review and approval. Update in the Status Box of the Database.

6.3.13.  Upon receipt of the draft, review comments and incorporate any additional amendments into the electronic file in the Draft folder of the database.  Log the circulation details again in the Status box. Re-circulate the final document for the appropriate approval signature according to section 4 of SOP QMS-010.

6.3.14.  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 authorized copies in the satellite files of relevant departments. See section 6.2.7 for location of the satellite files.

6.3.15.  Print the draft document, review comments, and incorporate any additional amendments into the electronic file. Write new status in the status box. Recirculate the final document for the appropriate approval signature according to section 4 of SOP QMS-010.

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 authorized 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

8.            Master Document Review Frequency

8.1.         All master documents are to be reviewed every 3 years from the date of issue or as deemed appropriate by the compendia requirement.

8.2.         If the requirement is no longer required then archive the document.

8.3.         If changes are to be made on the document, then revise the document.

8.4.         If no changes are needed during the review period, the evidence must be shown on the document indicating it has been reviewed by the due date. Evidence can be in the form if using ‘Reviewed by and date’ stamp with certified signatures to demonstrate that the reviewing process has been carried out.

9.            Satellite Document Files

9.1.         Satellite File Administration

9.1.1.     Satellite File

The Technical Service Staff oversees the Satellite File Locations Directory.
Satellite Files contain “Authorized” copies of all Master Documents indicated for that specific Satellite File location.

9.1.2.     File Administrator

Each Satellite Document Location File has a local File Administrator who liaises with the Technical Service Staff to ensure the file is up to date.

9.1.3.     New Documents/New Versions

New documents are to be filed in the Satellite File in numerical order.  When new versions of Documents are received, replace the previous version in the file and return the superseded version to the Technical Service Staff.

9.1.4.     Cancelled Documents

On notification from Technical Service Staff that a document is cancelled, remove the document from the Satellite file and return it to the Technical Service Staff.

9.1.5.     Library Log form (Form-415)

This form is to be filled out for removal or borrowing of documentation.  This form is placed at the front of the Satellite File, or in a prominent position if the Satellite Document Location is temporarily changed. 

10.         Appendix 1 – Flowchart for Preparation and Change of Master Documents

11.         Appendix 2 – Flowchart for Distribution of Master Documents

Summary of Changes