Standard Operating Procedure

Title: Quality Documentation Management and Change Control

Department Quality Management Document no QMS-015

Prepared by: Date: Supersedes:

Checked by: Date: Date Issued:

Approved by: Date: Review Date:

Document Owner
Quality Assurance Manager
Affected Parties
All Manufacturing Employees
Purpose
To define the procedures for Sydco 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
Quality SOPs, Forms, Policies, Manuals, Visual Display, Audit Reports, Training Session Plans,
Documents GMP agreements. (See SOP QMS-010 for listing)
Technical Documents controlled by the Technical Service Department e.g. Control Method, Raw
Documents Material Specification and Test Report.
Packaging Packaging Material Specifications created and maintained in the Database by Technical
Documents Service Department.
Document A central database to prepare, control and update of Quality Documents, Te chnical
Database documents and Master file documents.
File Administrator The team member who has been nominated to administer the area Satellite Document
Files.
Prepared By The person who has written the document. This may be an employee who has current
charge of the system/process as described by position description or training.
Checked By The Team Specialist, Supervisor or Manager who has direct charge of the
system/process.
Approved By The position or department noted in the Approval Matrix in SOP QMS-010.
Verified By This applies to external documents. Person who acknowledges the receipt of
documentation in full to Sydco. i.e. Maintenance & Operation Manuals, Manuals
General, Procedural Manuals, Project Files.
Confirmed By Person who confirms the d ocuments provided are consistent with specifications and
accurately reflects the project to date. Applies to External Documents. i.e. Maintenance &
Operation Manuals, Manuals General, Procedural Manuals, Project Files.
Revision History Brief summary i n point form of changes made to a Document during update. Includes
references to specific changes to other cross -referenced documentation.
Master Document A signed, white, hardcopy of the document.
Soft Copy The electronic copy of the Master Document fi led in the applicable, secured directory.
Soft copy has the signatory s names and required dates typed into the file prior to issue.
Authorised Copy A printed hardcopy photocopied version of the Master Document, which is authorised by a
signed, dated and stamped in red .

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control

4. Cancelling Quality Documentation ................................ ................................ ................................ ..... 7

5. Review of Quality Documentation ................................ ................................ ................................ ...... 7
6. SOP Reading Compliance ................................ ................................ ................................ ................. 7
7. Satellite Document Files See Appendix 3................................ ................................ ........................ 7
8. Technical Files, Project Files and External Manuals ................................ ................................ ........... 8
9. Obsolete Quality Documentation ................................ ................................ ................................ ....... 9
10. Audit Reports and Quality Assurance Agreement ................................ ................................ ............... 9
11. Appendix 1 - Category Selection & Numbering Procedure ................................ ................................ . 9
12. Appendix 2 Templates for creation of new documents................................ ................................ ....11
13. Appendix 3 - Administration of Satellite Documentation Files ................................ ............................ 12
14. Summery of Changes ................................ ................................ ................................ ....................... 13

Procedure
1. Quality Documentation

Quality Documentation refers to the following document types :

i In-House Quality Documents, e.g. Policies, Manuals, SOPs, Forms, Visual Display (VD), Audit
reports, Manuals, Training Session Plans.
i External Quality Documents, e.g. Regulatory Standards, TPM Dispatch Records; Technical Files.
Quality Assurance (GMP) Agreements.
i 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:
i 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).
i 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)
i 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).
i See SOP QMS-010 for the structure of the Document Database.
The Quality Documents and Quality Audi t 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

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control

i 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.
i The Header and Foo ters 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. Flowchart - Creation or Modification of Quality Documentation

New Document Existing Document

to be created requiring updating

Make hand written

Contact DCO for issue of Request DCO to put changes to a
New Document No. document in Printed copy of the
Draft folder for document marked
editing "For Review only" &
send to DCO.
DCO raises new
Document No. in
Document Database Update Revision DCO amends
History electronic copy

Author may then open DCO will create the

appropriate Document document in
Type template & Draft folder and
"SAVE AS" into advise author of
Draft folder Doc.No.

Advise DCO when editing of

document is complete

DCO will transfer document to Circulation folder

DCO prints and forwards hardcopy (Master) for

signing by Author, Manager and final Approval.

Handwrite changes and

DCO =
return document to DCO
Document Control Officer Additional
Changes
Yes
required? Return document to DCO and
request document moved to
No DRAFT folder

Return document
to DCO

DCO issues the document in live

folder
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Standard Operating Procedure
Title: Quality Documentation Management and Change Control

3.5.6. If the document is corre ct 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, signatorie s 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 m ust 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

i A document can only be cancelled by an Area Specialist, a Supervisor, or a Manager.
i Notification in writing is to be sent to the DCO to cancel a document.
i The person cancelling the document must ensure all relevant people are informed before
cancellation.
i 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.
i An Advice of Cancellation report is sent to the file administrators.

5. Review of Quality Documentati on

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 au thor 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 r eading 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

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control

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, Presentat ions, 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 Sydco 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:
= Number allocated to specific organisations (as listed in the table below)
= The number of GMP agreements with a specific organ isation, 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 Sydco and contractor)

Check the existing GMP agreements for this company in th e 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

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control

QA Agreement GMP GMP-XXX.Y.Z

Investigation/Incident Meeting INI/INV -INI-XXX or YY-INV-
Minutes
Position Paper POS POS-000
Quality Template TEM TEM-000
TPM Dispatch Report TPM File Name = CODE NO. e.g. 00145
Technical Files TF TF-000
Project Files PF PF-000
Presentation PPT PPT-000
Standards, Compendia STD STD-000

11.7. Numbering of External Documents

The externally derived document number is used for external documents. These include:
i Regulatory Standards
i Compendia

12. Appendix 2 Templates for creation of new documents

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

Audit Reports TEM-080

Forms and Visual Display TEM -090
Investigation/Incident Meeting Minutes Form-455
Training Report TEM -085
Quality Manuals (in-house) TEM -110
Position Paper TEM -130
Quality Assurance (GMP) Agreement TEM -100
SOP template TEM -095
TPM Dispatch Report TEM -105
Vendor Audit Reports TEM -120
Note: Policies and Manuals may utilise a customised format relevant to the purpose of the
document but must still comply with Corporate Guidelines.

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control

14. Summery of Changes

Version # Revision History
QMS-015 New

End of Procedure

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 Form-410
Issue date:
Document Location In Satellite File
(Ref. SOP QMS -005)

This form is to be used if a document (e.g. SOP) is not filed in the Satellite File but is located elsewhere
in the Team Area , e.g. placed on a machine .

Please fill in this form so that the File Administrator can locate the document if it is
superseded/cancelled.

File this form in the sleeve where the document (e.g. SOP) would normally be filed in the Satellite
Documentation File .

Satellite File No.

Doc. No. Version No.

Title

is located

at

File Location: Date Printed: Page 15 of 25

 Form-455
Issue date:
Incident / Investigation Report / (Ref. SOP QMS120)
Report No. YY-INI-XXX or YY-INV-
DR Number:

Investigation Type
This should list the type of investigation
(eg. Process Failure, Operator Error, etc.).

Executive Summary
The executive summary should contain a brief description of the event, root cause found during the investigation
and a final summary on product disposi tion.

Name (Position) Signature Date

Prepared by:

Checked by:

Authorised by:

Approved by:

File Location: Date Printed: Page 17 of 25

 Form-455
Issue date:
Incident / Investigation Report / (Ref. SOP QMS120)
Report No. YY-INI-XXX or YY-INV-
DR Number:

Here is where you outline whether this event could have an impact on any other equipment or processes and
your rational as to why you have made this conclusion.

You should also explore whether this is a repeat event or the first time this has occurred.

6. Product Disposition

6.1. Product made prior to the event

Here is where you outline the risk assessment and impact to product made prior to the event and
rationale as to why it is either accept able or not.

6.2. Product made during the event

Here is where you outline the risk assessment and impact to product made during the event and
rationale as to why it is either acceptable or not.

6.3. Product made after the event

Here is where you outline the risk assessment and impact to product made after the event and
rationale as to why it is either acceptable or not.

7. Summary

Here is where you write your conclusion to the investigation, you must summarise the overall root cause found
during the investigation, the impact on this batch and any other batches and the overall batch disposition.

7.1. Root Cause

State the root cause or suspect cause if root cause was not determined.

7.2. Repeat Event

State if a similar event occurred in the last 12 months and DR reference.

7.3. Batch Disposition

State final batch disposition and reasoning behind the decision.

7.4. Impact on other batches / processes

State if other batches/processes are impacted and reasoning behind the decision.

8. List of Attachments

Brief list of attachments to be a dded here

8.1. Attachment Summary of Investigation Tasks

File Location: Date Printed: Page 19 of 25

 Form-455
Issue date:
Incident / Investigation Report / (Ref. SOP QMS120)
Report No. YY-INI-XXX or YY-INV-
DR Number:

Copies of Analytical data associated with this event.

8.10. Attachment Validation Data

Copies of Validation data associated with this event.

8.11. Attachment - Evidence of actions completed

8.12. Attachment - Employee Awareness Forms

Employees counselled as a result of this event should sign a form to say that they
understand the nature of their involvement and be filed be hind this attachment.

8.13. Attachment - SOP Updates

Evidence of critical updates to SOPs to be filed behind this attachment.

8.14. Attachment - Training / Assessment Updates

Evidence of critical updates to training and assessment be filed behind this attachment.

File Location: Date Printed: Page 21 of 25

 Form-495 & 505
Issue date:
Form Ready for Signing an d Document Creation or Change Request
(Ref. SOP QMS -015)
Document Change Control Form

1. To complete this form :

i Print a copy of this form.
i Add details in section 2 and in relevant section 3. or 4. ( Create or Cancel).
i Add details of Line Manager in section 5.
i Send to the Line Manager for approval to proceed.
i Line Manager is to obtain appropriate approval from Quality Assurance.
i On approval/rejection, send this form to Document Management Department who will advise Form
Initiator of outcome of request, or request further information, if required.

2. Form Initiator
Date Area
Initiator Name Position
Line Manager s Name

3. Create New Document

Document Type (SOP, Form, VD etc.): (if VD/Form incl. SOP Cross Ref.) .
Title
Reason for Creation
(new machinery; new process, etc.)

4. Cancel Document
Document Type (SOP, Form, VD etc.)
Document No
Reason for Cancellation (obsolete
machinery, process or procedure; covered
in other SOP, etc.)
Comments:

5. Approval: Line Manager

Print Name
Sign for approval Date:

6. Approval (Quality Assurance Dept. Managers)

Note: Cannot be Manager of Stakeholder Area / Dept.
Print Name Position
Sign for Date
approval

If this is a QA area document, ONLY the QA Manager can approve. Send printed, signed form to DCO

7. DCO
Initiator informed?
Date

File Location: Date Printed: Page 23 of 25