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QMS 015 Quality Documentation Management and Change Control Sample

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233 views4 pages

QMS 015 Quality Documentation Management and Change Control Sample

Uploaded by

Sameh Mostafa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Standard Operating Procedure

Title: Quality Documentation Management and Change Control


Soft Copy The electronic copy of the Master Document filed 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 .
Uncontrolled Any document, which is printed from the electronic copy or photocopied version without
copy having red stamp on it. Each quality document has a footer statement of “This is not an
approved copy unless stamped red”
Hardcopy Only Documents that are not maintained electronically. Documents are generally of externally
Documents derived origin but are being incorporated into Site’s Quality System.
Satellite file A set of relevant hardcopy documents remotely located to ensure ready access to the
Location documents by all employees. These locations have designated numbers that are included
in the Database record for each document.
TPM Dispatch Third Party Manufacturing Dispatch Records.
Records
GMP Good Manufacturing Practice.

Related Documents
Form-395 SOP Ready for Signing
Form-410 Document Location in Satellite File
Form-415 Library Log Form
Form-455 Incident or Investigation Report Form
Form-495 Form Ready for Signing
Form-505 Document Creation or Change Request
Form-530 Reading Compliance Form
Form-535 GMP Agreement Log
TEM-080 Internal Audit Report Template
TEM-085 Training Report Template
TEM-090 Form, VD Template
TEM-095 SOP Template
TEM-110 In-house Manual Template
TEM-100 Quality Assurance Agreement Template
TEM-105 Third Party Manufacture Dispatch Report Template
TEM-120 Vendor Audit Report Template
TEM-130 Position Paper Template
QMS-010 All Documents - Classification, Definition and Approval Matrix
QMS-030 Preparation, Maintenance and Change Control of Master Documents
QMS-020 Documentation Rule for GMP Documents
QMS-025 Quality Documentation - Control, Tracking and Distribution
QMS-080 Audits

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control
3.4. Document Approval

3.4.1. When the document is completed, inform the DCO.


The following data must be provided to the DCO:
1 Document Title
2 Document Type
3 Document Owner
4 Signing – the signatories of the document (prepared, checked,
authorised) (see SOP QMS-010)
5 Cross References – to other Controlled Documents
6 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:


1 Placing the document in the appropriate “Live” folder in the database
2 Sending required “Authorised Copy” with red stamp, sign and date to the
Satellite file locations for Teams to use.
3 Satellite File Administrator removes superseded copy (if applicable) for
return to DCO and files new document.
4 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.
5 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 Authorised copies of the SOP are to be

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

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Standard Operating Procedure
Title: Quality Documentation Management and Change Control
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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