QMS-015 GMP Quality Documentation Management and Change Control

Document Owner

Quality Assurance Manager

Affected Parties

All Manufacturing Employees

Purpose

To define the procedures for Site personnel to Create, Modify, Review and Cancel Quality Documents and to be in compliance with requirements for Quality Documentation.

Scope

This procedure describes the role of manufacturing personnel in creating and reviewing/updating Quality Documentation, Document Control Officers, File Administrators.

All personnel involve in the manufacturing activities required to read Quality Documentation and responsible for creating and updating procedures when required.

Definition

Related Documents

EHS Statement

This SOP covers documentation systems only – there is no EHS impact.

Procedure

1.            Quality Documentation

Quality Documentation refers to the following document types:

– In-House Quality Documents, ie. Policies, Manuals, SOPs, Forms, Visual Display (VD), Audit reports, Manuals, Training Session Plans.

– External Quality Documents ie. Regulatory Standards, TPM Dispatch Records; Technical Files. Quality Assurance (GMP) Agreements.

– Packaging Specifications

See SOP QMS-010 for detailed listing of quality documents and their definition

2.            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:

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

– “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)

– “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 (See SOP QMS-030).

– 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 Technical and/or Master file documents sections are maintained by Technical Service Departments.

3.            Creation or Modification of Quality Documentation

3.1.         Creation – New Documents

3.1.1.     Determine the type of document to be created. Contact the Document Control Officer (DCO) if clarification is required.

3.1.2.     For SOPs, determine the area category of the SOP. See Appendix 1.

3.1.3.     Send a Request to Create or Change Control Form (Form-505) to DCO. Request a document number from the DCO.

3.1.4.     Create a new document using the appropriate template, or request the DCO to create a new document. See Appendix 2 for templates to be used.

Templates can be located in “Template” folder in the Documentation Database.

3.1.5.     All Forms must have a cross reference to documentation, e.g. SOPs, MI Sheets, Manuals, TRN – this information is to be added in the header of the Form.

3.1.6.     Save the document as the document number (excluding version) in “Draft” folder in the Documentation Database

3.1.7.     No format styles are to be changed in the template. The body layout may be modified to suit the purpose of the document, i.e. flowcharts, visual aids, tables, etc., may be added.

3.1.8.     The Header and Footers are not to be changed as they control the document’s conformance to Site’s documented Quality System. If required, the DCO will amend.

3.1.9.     Complete the file Properties data as follows:

3.2.         Modification

Documents can be modified in two ways:

3.2.1.     Print an “Uncontrolled copy” with required changes marked “Review Only” in red ink to the DCO.

Do not mark the original “authorized copy” – it remains in Satellite File.

OR

3.2.2.     Notify the DCO of the document to be modified. The DCO will create a copy of the document in the “Draft” folder and adjust entered in the “Under Review” folder of the Document Database to indicate the document is under review.

– Make changes to the document as required.

– Note changes in the Revision History section at the end of the document.

– No format styles are to be changed in the template. The body layout may be modified to suit the purpose of the document, i.e. flowcharts, visual aids, tables, etc. may be added.

– The Header and Footers are not to be changed as they control the document’s conformance to company’s documented Quality System. If required, the DCO will amend.

Note: If the document is printed at any stage without the red stamp on it, it must be identified as an “Uncontrolled Copy” and must be destroyed within one day.

3.3.        Figure 1: Flowchart – Creation or Modification of Quality Documentation

3.4.         Document Approval

3.4.1.     When the document is completed, inform the DCO.
The following data must be provided to the DCO:

– Document Title

– Document Type

– Document Owner

– Signing – the signatories of the document (prepared, checked, authorized) (see SOP QMS-010)

– Cross References – to other Controlled Documents

– Distribution

3.4.2.     The signatories of the document can be determined using the Approval Matrix, see SOP QMS-010. The ‘Prepared by’ signature is the document author.

The ‘Checked by’ signature is the author’s manager, or a person with relevant technical knowledge.

3.4.3.     The DCO will circulate the document for appropriate approval.

3.4.4.     The DCO will issue the document by:

– Placing the document in the appropriate “Live” folder in the database

– Sending required “Authorized Copy” with red stamp, sign and date to the Satellite file locations for Teams to use.

– Satellite File Administrator removes superseded copy (if applicable) for return to DCO and files new document.

– If the document is to be placed other than in the Satellite File, a Form-405 must be printed and filled in and placed in the Satellite file so the remote document can be located in future.

– The File Administrator then advises Team of new document to read and to sign the “Reading Compliance” form attached.

3.5.         Responsibilities of Signatories

3.5.1.     Signatories will receive documents for signing with the “SOP Ready for Signing” routing sheet (Form-395), or “Form Ready for Signing” routing sheet (Form-495) and, if applicable, attached superseded version of the document.

3.5.2.     Signatories of documents are required to review the new document for:

– Correctness, effectiveness and clarity.

– Appropriateness and scope of EHS statement

– Document Revision History

3.5.3.     For new SOPs and Forms, the “Checked By” signatory, usually the line manager, is to indicate if the document will be referenced in MI Sheets.

3.5.4.     For new SOPs, if a Satellite File list is attached, the “Checked By” signatory is to indicate to which Satellite Files Authorized copies of the SOP are to be distributed.

3.5.5.     Production teams are encouraged to communicate with their team to make sure ALL required changes and additions have been made.

3.5.6.     If the document is correct for signing, signatories are to sign and date the approval table. All signatories are to forward the documents to the DCO after each signing as per Form-395 or for Forms after the “checked by” stage, as per Form-495.

3.5.7.     If changes are required, signatories are to mark any changes required and indicate on the routing sheet (Form-395 or Form-495) that changes are required.

Alternatively, signatories are to request the DCO to place the document in Draft folder, so the author can make the changes. The DCO must be notified again when the document is ready to be distributed for approval.

Signatories are to forward the documents to the DCO in either case.

4.            Cancelling Quality Documentation

– A document can only be cancelled by an Area Specialist, a Supervisor, or a Manager.

– Notification in writing is to be sent to the DCO to cancel a document.

– The person cancelling the document must ensure all relevant people are informed before cancellation.

– The DCO will place all cross referenced documents into Draft folder and inform their authors of the cancellation of the document cross referenced. The authors must determine the impact of the cancellation of the document.

– An “Advice of Cancellation” report is sent to the file administrators.

5.            Review of Quality Documentation

Documents are to be reviewed after a defined period from creation or last update. See SOP QMS-010 for different review periods for all document types. Updating of documents may occur at any time prior to required review date if necessary.

5.1.         Documents due for review

5.1.1.     The DCO will forward the “Due For Review Within The Next Three Months” report to relevant personnel. An extension of the review date or change to responsible personnel may be requested.

5.1.2.     The DCO will save the document in Draft folder. The author will Review the document and make changes as required.

5.2.         Responsibility

It is the responsibility of the assigned individual to make sure the document is reviewed and re-issued by the review date.

6.            SOP Reading Compliance

Employees are responsible for reading all relevant SOPs to maintain GMP compliance. Reading Compliance is indicated by signing of the “Reading Compliance” form (Form-530) attached to the SOPs. Teams with designated Satellite files must read all new SOPs and re-issued SOPs. The individuals indicate their compliance by signing and dating the “Reading Compliance” form attached to the SOP.

7.            Satellite Document Files – See Appendix 3

7.1.         Satellite File Administration

7.1.1.     Satellite File

The DCO oversees the Satellite File Locations Directory.
There are two types of Satellite Files:

Satellite Files, which contain “Authorized” copies of all Documents indicated for that specific Satellite File location.

Satellite Files, which only contain the Reading Compliance forms for all Documents indicated for that specific Satellite File location.

7.1.2.     File Administrator

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

7.1.3.     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 with the Reading Compliance form to the DCO.

7.1.4.     Cancelled Documents

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

7.1.5.     Documents to be located external to Satellite File

If the document is to be placed other than in the Satellite File, a Form-405 must be printed and filled in and placed in the Satellite File so the remote document can be located in future.

7.1.6.     “Reading Compliance” Forms

The file administrator is to facilitate the signing by appropriate staff of the “Reading Compliance” form held in the Satellite File. See Section 6.

7.1.7.     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 a library or compactus shelving.

8.            Technical Files, Project Files and External Manuals

All Technical and Project Files are logged into the Documentation Database and the hard copy stored for future reference. Each file is given a number for tracking purposes.

8.1.         Logging of Technical Files

8.1.1.     Forward the file to the DCO who will number and log it into the database.

8.1.2.     The file is stored in the Technical File compactus.

8.2.         Project Files and External Manuals (Operation/Equipment Manuals)

8.2.1.     Fill in the Library Log for Equipment Manuals and send to the DCO who will number and log into the database.

8.2.2.     The DCO will print a “Print Approval Request” showing the details of the database record. This is to be filed in the front of the document file.

8.2.3.     A label should be generated and placed on the spine of the file stating the manual number and location. The file is then placed in the technical file compactus location. Manuals may be stored in Production locations as per Satellite File locations.

9.            Obsolete Quality Documentation

9.1.         Electronic copies of SOPs, Training Session Plans, Presentations, Forms, Policies and Visual Displays etc are retained in “Obsolete” folder of the Document Database. See SOP QMS-010 to get the retention times for quality documents.

9.2.         Obsolete documents can be burnt into a computer disc for easy storage and accessibility.

9.3.         To retrieve a copy of an obsolete document, contact the DCO.

10.         Audit Reports and Quality Assurance Agreement

10.1.      Audit Reports

Audit reports are logged in the Documentation Database according to SOP QMS-080.

10.2.      Quality Assurance (GMP) Agreements

Quality Assurance (GMP) Agreements are prepared by the Quality assurance Department and are written to outline the basic responsibilities and actions undertaken by Site and any contracted party who has direct impact in the manufacturing stages of product.

10.2.1.  GMP agreements have a specific format for their numbering system as illustrated by the following format:

GMP-XXX.Y.Z

Where:

XXX   =     Number allocated to specific organisations (as listed in the table below)

Y        =     The number of GMP agreements with a specific organisation, listed sequentially
(e.g. 1 = first, 2 = second, 3 = third Agreement etc)

Z        =     Version number of a specific GMP agreement

10.2.2.  Creating a GMP agreement (between Site and contractor)

Check the existing GMP agreements for this company in the Contracts Register to find out if any agreements already exist for this company.

Use the GMP template TEM-100 to draft the agreement.

Sign off for the agreement should be performed by the Quality Assurance Manager for both the parties.

10.2.3.  Control, Tracking and Distribution of GMP agreements

Once the agreement is fully signed, ensure that the appropriate database is updated with the new GMP agreement details as per SOP QMS-025.

 11.         Appendix 1 – Category Selection & Numbering Procedure

11.1.      A unique SOP number identifies each SOP. When the SOP is ready to be typed, DCO will ask the Quality Assurance department to provide a new number or to confirm an existing one.

11.2.      The SOP numbers are used to collect SOPs into readily identifiable groups based on the work area or function.

11.3.      Each number consists of two parts- a three or four letter prefix followed by a three digit number.

11.4.      The prefix identifies the work area or function to which the SOP belongs.

MAN     –           Manufacturing

EHS     –           Environmental Health and Safety

ENG     –           Engineering

LAB      –           Laboratory

QA       –           Quality Assurance

QMS     –           Quality Management System

TMS     –           Training Management System

TSV      –           Technical Service

WAR     –           Warehouse

SEC     –           Security

HRM     –           Human Resource Management

VAL      –           Validation

CUS     –           Customer Service

PLN      –           Planning and Purchasing

11.5.      The three digit number for each group is allocated sequentially, starting with 005 and increasing in steps of five, i.e. 005, 010, 015, 020 etc. This allows future SOPs which may be closely related to existing ones to be grouped together. Keeping similar SOP’s together makes searching for a specific easier.

11.6.      Numbering of other Quality Documentation

All Quality Documentation other than SOPs, External Documents, Audits and Technical Documentation is numbered using a prefix for document type, a sequential number within that document type, and a version number. The DCO will determine the next available number.

Note: For Technical Documentation numbering see SOP QMS-030 & for Audit numbering see SOP QMS-080.

11.7.      Numbering of External Documents

The externally derived document number is used for external documents. These include:

– Regulatory Standards

– Compendia

12.         Appendix 2 – Templates for creation of new documents

The following Templates are to be used for the applicable Quality Document type:

Note: Policies and Manuals may utilize a customized format relevant to the purpose of the document but must still comply with Corporate Guidelines.

Appendix 3: Figure 2: Administration of Satellite Documentation Files

Note: If the document is to be placed other than in the Satellite File, a Form-405 must be printed and filled in and placed in the Satellite file so the remote document can be located in future.

Summary of Changes