Standard Operating Procedure

Title: All Documents – Classification, Definition and Approval Matrix

Department Quality Management Document no QMS-010

Prepared by: Date: Supersedes:

Checked by: Date: Date Issued:

Approved by: Date: Review Date:

Document Owner
Quality Assurance Manager

Affected Parties
All Sydco colleagues working in Technical/QA/Regulatory Departments

Purpose
This procedure classifies and defines all types of Quality, Technical/Master file documents. It provides
an integrated list of Responsibilities of Authorities, Approval Matrix and Retention times of all quality
and Technical/Mater file documents. An schematic diagram of documentation database to have clear
understanding of how document is managed.

Scope
The document lists used in this SOP is explained elaborately in other documentation SOPs with
appropriate reference to content of this SOP.

Definition
N/A

Related Documents
QMS-015 Quality Documentation Management and Change Control
QMS-030 Preparation, Maintenance and Change Control of Master Documents
QMS-080 Audits

EHS Statement
No EHS impact found in this procedure

Table of Contents

1. Classification of Documents......................................................................................................2
2. Definition of all types of Quality Documents .............................................................................3
3. Approval Matrix and Review Period of Quality Documents ......................................................5
4. Approval Matrix for Master File Documents..............................................................................6
5. Review Period for Master File Documents ...............................................................................6
6. Responsibilities for Authorising Master File Documents ..........................................................7
7. Document Retention Times and Responsible Persons (All Documents) .................................9
8. Document Database for Quality Document ............................................................................10
9. Document Database for Master File Document......................................................................11
10. Document Database for Audit Document ...............................................................................12
11. Summery of Changes .............................................................................................................12

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 Standard Operating Procedure
Title: All Documents – Classification, Definition and Approval Matrix

2. Definition of all types of Quality Documents

(This table does not include Master file documents).

Document Type Definition

Standard Operating Standard Operating Procedures (SOPs) are issued to specifically instruct employees in
Procedure (SOP) areas of responsibility, work instructions, appropriate specifications and required records
SOPs outline procedures, which must be followed to claim compliance with GMP
principles or other Statutory rules and regulations.
Procedures can take the form of a narrative, a flow chart, a process map, or any other
suitable form, however must be written in appropriate, effective grammatical style.
Form A document which is to be printed at the time of use and filled out for the purpose of
becoming a record (e.g. Line Opening Form), or for the purpose of becoming Visual aid.
Policy Statement from Management on the use and application of certain activities and
processes within the organization.
Visual Display A form requiring no additional data to be added (i.e. written information) which provides
visual information to instruct in the process, e.g. Tablets visual Defects. The information
can be in the form of pictures or photographs; flowchart; operating instructions; or a
notice. The Visual Display is usually located in a permanent position, however maybe in
use for a specific period of time, e.g. for a single batch. Pages from a single Visual
Display must be located together in a specified location. A location form (FM-0194)
must be placed in the Satellite File so the VD can be located if superseded or cancelled.
(See SOP A.8.1)
Audit Report An audit is a systematic and independent review to verify compliance, suitability and/or
data integrity.
Audits report may assess: systems, processes, procedures, facilities, products, records
and/or data for compliance with policies, standards, procedures, guidelines, regulations
or regulatory submissions
Quality Manual Instructions written in-house to be followed for the use of equipment, systems or
processes.
Training Session Plan The aim of the Training Session Plan is to overview and describes the rationale behind a
process. Training Session Plans cross-reference relevant SOPs and Production
Documentation.
Quality Assurance An Agreement is written to outline the basic GMP responsibilities and actions
(GMP) Agreement undertaken by Sydco and any contracted party who has direct impact in the
manufacturing stages of product (including contract manufacture, secondary packaging,
storage and distribution).
Investigation/Incident A report where an investigation or incident causalities and findings are documented in
Meeting Minutes systematic order.
Position Paper A Position Paper is created when Sydco reviews its current manufacturing products and
processes against the code of GMP and decides to perform in excess of the stated
requirements or to not perform them.
The Position Paper should outline the actual requirement stated in the relevant
document, the rational as to why Sydco is doing something different to the requirement
and a risk assessment which identifies why this is acceptable.
Quality Template A template is for creating a particular documentation.
Vendor Audit Report Audit report prepared after vendor evaluation.
TPM Dispatch Record This is a delivery docket created and issued by a company contracted to supply products
manufactured for sydco

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Standard Operating Procedure
Title: All Documents – Classification, Definition and Approval Matrix
3. Approval Matrix and Review Period of Quality Documents
SOPs are approved by Quality Managers as per SOP QMS-015

Document Type Prepared Checked Approved Review Period

By: By: By:
SOP

QA Manager 3 yrs
General Forms

QA Manager 3 yrs
Policies N/A
QA Manager 3 yrs
Visual Display
N/A QA Manager 3 yrs
Audit Reports
N/A QA Manager N/A
Lab/Mfg. Area Mgr/GMP
Training
3 yrs
Representative Training Officer
5 years from
QA (GMP) Agreements
N/A QA Manager
signing
Investigation/Incident Lab/Mfg. Retain with the

QA Manager
Meeting Minutes Representative batch documents
Position Papers N/A
QA Manager 3 yrs
Quality Template

QA Manager 3 yrs

Vendor Audit Report

QA Manager 1 year until the

contact ends
Laboratory
TPM Dispatch Report N/A QA Manager N/A
Manager

N/A N/A Technical Service N/A

Technical Files
Manager
Maintenance & Operational
N/A Verified by Confirmed by, N/A
Manuals, Procedural
Functional Manager
Manuals
N/A Verified by Confirmed by, N/A
Project Files
Functional Manager
External Documents, i.e.
Regulatory Standards N/A N/A QA Manager N/A

Packaging
Developm Procurement Technical Service
Packaging Specifications N/A
ent Manager

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Standard Operating Procedure
Title: All Documents – Classification, Definition and Approval Matrix
6. Responsibilities for Authorising Master File Documents

Document Technical QA Dept Checks Regulatory Checks

Control Method • Complies with registered Product Details Analytical • Complies with registered Product Details
and other registered details and other registered details
(CM) • Complies with registered Product Details
• Reflects current pharmacopoeial or and other registered details
validated in-house methods
• Reflects current pharmacopoeial or
• Complies with validated methods validated in-house methods
(where applicable)
• Complies with validated methods
(where applicable)

Specifications • Compliance with registered Product Details Analytical • Updated to current pharmacopoeia
and other registered details (existing
(SPC) • Updated to current pharmacopoeia • Complies with registered Product Details
products)
and other registered details
• Updated to current pharmacopoeia
Formulation • Complies with registered Product Details • Reflects bulk formulations used in • Complies with registered Product Details
(FLN) and other registered details production and other registered details

• Updated in line with development studies

Packaging • Complies with registered Product Details Analytical • Complies with registered Product Details
Materials based on artwork specification and other and other registered details
Specifications • Reflects current pharmacopoeia
registered details
and Test Report • Reflects current in-house specification
• Based on local production knowledge and (where applicable)
(PMS) validation

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Standard Operating Procedure
Title: All Documents – Classification, Definition and Approval Matrix

7. Document Retention Times and Responsible Persons (All Documents)

Document Name Retention Time Responsible Person

Batch Documents 13 years from the date of manufacture Laboratory Manager

Specifications, Formulations, Bill 7 years Technical Service Manager

of materials

Raw material Specification and 13 years from the date of receipt (reassay Laboratory Manager

Test Report. report should be kept for 13 years from the

date of reassay)

Finished Product Specification 13 years from the date of production Laboratory Manager

and Test Report.

Laboratory Workbook 13 years Laboratory Manager

Audit Reports Until closure of audit – must be QA Manager

destroyed on completion

Packaging Material Specification 7 years Laboratory Manager

and Test Report

Product Complaint Files 13 years QA Manager

Validation Records According to master validation plan Technical Service Manager

Production Log books 7 years Production Manager

Stability Records 13 years from the date of manufacture Laboratory Manager

Training Records 6 years after staff leaves from GMP training Officer
employment

Deviation Report (DR) 7 years QA Manager

Calibration Records 7 years Production manager/

Laboratory / Production Engineering manager/

instruments Laboratory manager

Pest Control Records 7 years Maintenance manager

Returned Goods Description 7 years QA Manager

Annual Product Reviews 7 years QA Manager

Other GMP Documents At least 7 years As appropriate

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Standard Operating Procedure
Title: All Documents – Classification, Definition and Approval Matrix

9. Document Database for Master File Document

Live

Draft Control Method

Circulation Specifications

Obsolete Packaging Materials

specifications – Test
Report
Superseded

Manufacturing Formula
Under review

Manufacturing Instruction
Templates

Status box Raw Material

Specifications and Test
Report
Master Document List
Finished Goods
Live Specification and Test
Report

Bill of Materials

Stability Specification

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