Department | Quality Management | Document no | QMS-010 | ||
Title | Classification, Definition and Approval Matrix of GMP Documents | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
All Site 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. A 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
1. Classification of Documents
The following table list all types all documents used in Site Quality management system which includes Quality Documents,
Technical Documents, Master file Documents.
Quality Documents | Prefix ID |
SOP | Area specific e.g QMS |
Forms | Form |
Policies | POL |
Visual Display | VD |
Audit Reports | AUD |
Quality Manual | MAN |
Training | TRN |
QA (GMP) Agreements | GMP |
Investigation/Incident Meeting Minutes | INV/INI |
Position Paper | POS |
Quality Template | TEM |
Vendor Audit Report | AUD-vendor no |
TPM (Third Party Manufacture) Dispatch Report | TPM |
Technical Files | TF |
Project File | PF |
Maintenance and Operation Manual | MAN |
Procedural Manual | MAN |
Presentation | PPT |
Regulatory Standards | STD |
Compendia | – |
Master File Documents | Prefix ID |
Control Method | CM |
Specification (Raw Material/Finished Product/Packaging) | SPC |
Formulation | FLN |
Packaging Material Specifications and Test Report | PMS |
Manufacturing Formula | MF |
Manufacturing Instruction | MI |
Bill of Materials | BOM |
Stability Specification | SS |
Finished Goods Specification and Test Report | FGS |
Raw Material Specification and Test Report | RMS |
2. Definition of all types of Quality Documents
(This table does not include Master file documents).
Document Type | Definition |
Standard Operating Procedure (SOP) | Standard Operating Procedures (SOPs) are issued to specifically instruct employees in 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 (GMP) Agreement | An Agreement is written to outline the basic GMP responsibilities and actions undertaken by Site and any contracted party who has direct impact in the manufacturing stages of product (including contract manufacture, secondary packaging, storage and distribution). |
Investigation/Incident Meeting Minutes | A report where an investigation or incident causalities and findings are documented in systematic order. |
Position Paper | A Position Paper is created when Site 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 Site 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 site |
Technical File | An in-house holding file kept as a record. Technical files may include: – Laboratory Logbooks – Production Logbooks – Videos – Course Manuals – Conference Papers – Collections of papers/reports (e.g. Incident Reports) – Presentations |
Project File | An in-house holding file kept as a record. Project files are in-house documentation relating to a specific project, usually relating to production equipment or systems. |
Maintenance and Operational/Procedural Manual | Instructions supplied from EXTERNAL vendors to be followed for the use of equipment, systems or processes. |
Compendia | BP/USP and Other internationally recognised guides. |
Regulatory Standards | Standards listed in compendia or other local and international guidelines e.g. ISO |
3. Approval Matrix and Review Period of Quality Documents
Document Type | Prepared By: | Checked By: | Approved By: | Review Period |
SOP | Required | Required | QA Manager | 3 yrs |
General Forms | Required | Required | QA Manager | 3 yrs |
Policies | N/A | Required | QA Manager | 3 yrs |
Visual Display | Required | N/A | QA Manager | 3 yrs |
Audit Reports | Required | N/A | QA Manager | N/A |
Training | Required | Lab/Mfg. Representative | Area Mgr/GMP Training Officer | 3 yrs |
QA (GMP) Agreements | Required | N/A | QA Manager | 5 years from signing |
Investigation/Incident Meeting Minutes | Required | Lab/Mfg. Representative | QA Manager | Retain with the batch documents |
Position Papers | N/A | Required | QA Manager | 3 yrs |
Quality Template | Required | Required | QA Manager | 3 yrs |
Vendor Audit Report | Required | Required | QA Manager | 1 year until the contact ends |
TPM Dispatch Report | N/A | Laboratory Manager | QA Manager | N/A |
Technical Files | N/A | N/A | Technical Service Manager | N/A |
Maintenance & Operational Manuals, Procedural Manuals | N/A | Verified by | Confirmed by, Functional Manager | N/A |
Project Files | N/A | Verified by | Confirmed by, Functional Manager | N/A |
External Documents, i.e. Regulatory Standards | N/A | N/A | QA Manager | N/A |
Packaging Specifications | Packaging Development | Procurement | Technical Service Manager | N/A |
4. Approval Matrix for Master File Documents
NOTE: Not all documents may be required for the Master File.
Prefix ID | Document Type | Quality Assurance | Technical | Production | Regulatory |
CM | Control Method | LM | TSM/TPM | – | – |
SPC | Specification | LM | TSM /TPM | – | RAM |
FLN | Formulation | QAM | TSM /TPM | PM | RAM |
PMS | Packaging Material Specification-Test Report | QAM | TSM /TPM | PM | RAM |
MF | Manufacturing Formula | QAM | TSM /TPM | PM | RAM |
MI | Manufacturing Instruction | QAM | TSM /TPM | PM | – |
BOM | Bill Of Materials | QAM | TSM /TPM | PM | – |
SS | Stability Specification | LM | TSM /TPM | – | – |
FGS | Finished Goods Specification and Test Report | LM | TSM/ TPM | – | – |
RMS | Raw Materials Specification and Test Report | LM | TSM /TPM | – | – |
Keys:
QAM Quality Assurance Manager | TSM Technical Service Manager |
PM Production Manager | TPM Technical Project Manager |
RAM Regulatory Affairs Manager | LM Laboratory Manager |
A delegate may be authorised to sign on behalf of the nominated, responsible person.
5. Review Period for Master File Documents
Prefix ID | Document Type | Review Period |
CM | Control Method | 3 years unless change initiated |
SPC | Specification | 3 years unless change initiated |
FLN | Formulation | 3 years unless change initiated |
PMS | Packaging Material Specification and Test Report | 3 years unless change initiated |
MF | Manufacturing Formula | 3 years unless change initiated |
MI | Manufacturing Instruction | 3 years unless change initiated |
BOM | Bill Of Materials | 3 years unless change initiated |
SS | Stability Specification | 3 years unless change initiated |
FGS | Finished Goods Specification and Test Report | 3 years unless change initiated |
RMS | Raw Materials Specification and Test Report | 3 years unless change initiated |
6. Responsibilities for Authorising Master File Documents
Document | Technical | QA Dept Checks | Regulatory Checks |
Control Method(CM) | · Complies with registered Product Details and other registered details · Reflects current pharmacopoeial or validated in-house methods · Complies with validated methods (where applicable) | Analytical · Complies with registered Product Details and other registered details · Reflects current pharmacopoeial or validated in-house methods · Complies with validated methods (where applicable) | · Complies with registered Product Details and other registered details |
Specifications(SPC) | · Compliance with registered Product Details and other registered details (existing products) · Updated to current pharmacopoeia | Analytical · Updated to current pharmacopoeia | · Updated to current pharmacopoeia · Complies with registered Product Details and other registered details |
Formulation (FLN) | · Complies with registered Product Details and other registered details · Updated in line with development studies | · Reflects bulk formulations used in production | · Complies with registered Product Details and other registered details |
Packaging Materials Specifications and Test Report(PMS) | · Complies with registered Product Details based on artwork specification and other registered details · Based on local production knowledge and validation | Analytical · Reflects current pharmacopoeia · Reflects current in-house specification (where applicable) | · Complies with registered Product Details and other registered details |
Manufacturing Formula (MF) | · Complies with registered Product Details and other registered details · Batch size stated in line with machine capability and registered details | · Reflects bulk formulations used in production · Batch size stated in line with machine capability and registered details | · Complies with registered Product Details and other registered details |
Manufacturing Instruction(MI) | · Complies with registered Product Details and other registered details · Based on local production knowledge and validation | · Based on local production knowledge and validation | |
Bill of Materials(BOM) | · Complies with registered Product Details and other registered details · Batch size stated in line with machine capability and registered details | · Based on local production knowledge and validation | |
Stability Specification (SS) | · Compliance with registered Product Details or other registered details · Updated to current pharmacopoeia· Reflects stability of product | Analytical · Updated to current pharmacopoeia· Reflects stability of product | Not applicable |
Raw Material Specification and Test Report(RMS) | · Complies with registered Product Details · Reflects current pharmacopoeia· Reflects current in-house specification (where applicable) | Analytical · Reflects current pharmacopoeia · Reflects current in-house specification (where applicable) | Not applicable |
Finished Goods Specification and Test Report(FGS) | · Complies with registered Product Details · Reflects current pharmacopoeia· Reflects current in-house specification (where applicable) | Analytical · Reflects current pharmacopoeia· Reflects current in-house specification (where applicable) | Not applicable |
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 of materials | 7 years | Technical Service Manager |
Raw material Specification and Test Report. | 13 years from the date of receipt (reassay report should be kept for 13 years from the date of reassay) | Laboratory Manager |
Finished Product Specification and Test Report. | 13 years from the date of production | Laboratory Manager |
Laboratory Workbook | 13 years | Laboratory Manager |
Audit Reports | Until closure of audit – must be destroyed on completion | QA Manager |
Packaging Material Specification and Test Report | 7 years | Laboratory Manager |
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 employment | GMP training Officer |
Deviation Report (DR) | 7 years | QA Manager |
Calibration RecordsLaboratory / Production instruments | 7 years | Production manager/Engineering manager/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 |
8. Figure 1: Document Database for Quality Document
9 Figure 2: Document Database for Master File Document
10. Figure 3: Document Database for Quality Document
Summary of Changes
Version # | Revision History |
QMS-010 | New |