1.0 PURPOSE:
To lay down the procedure for the Preparation, Review and Approval of Validation Master Plan.
2.0 SCOPE:
This procedure applicable for preparation of Validation Master Plan at Pharmaceutical Manufacturing Facilities of (Company name).
3.0 DEFINITIONS:
3.1 Validation Master Plan:
The documented plan for qualification of a facility or part of a facility that identifies the layout of the operation, the associated utilities and systems, equipment, and the processes to be validated. Validation Master Plan also provides information as to the extent of the qualification and validation (IQ, OQ& PQ) required documentation, SOPs, acceptance criteria and responsibilities.
3.2 Validation Protocol:
3.3 Validation Report:
3.4 User Requirement Specification:
3.5 Design Qualification:
3.6 Installation Qualification:
3.7 Operational Qualification:
3.8 Performance Qualification:
3.9 Process Validation:
3.10 Calibration:
3.11 Revalidation:
4.0 RESPONSIBILITY:
4.1 QA Personnel:
4.1.1 Shall prepare the validation master plan.
4.2 Head QC/ Designee:
4.2.1 Shall Review the Validation Master Plan.
4.3 Head Production/ Designee:
4.3.1 Shall Review the Validation Master Plan
4.4 Head Engineering/ Designee:
4.4.1 Shall Review the Validation Master Plan
4.5 QA Head/ Designee:
4.5.1 Shall Approve the Validation Master Plan.
4.5.2 Shall responsible for the implementation / compliance of this procedure.
5.0 PROCEDURE:
5.1 The Validation Master Plan should provide an overview of the entire validation operations, including its organizational structure, content, and planning
5.2 Validation Master Plan shall be a summary document, which is brief and clear.
5.3 Validation Master Plan shall be prepared for an existing facility, when an existing facility undergoes renovation or for a new facility.
5.4 VMP shall identify the layout of the operations, the associated utilities and systems, the equipment, and the processes to be validated along with the information as to extent of the qualification and validation, required documentation, SOPs, acceptance criteria and responsibilities.
5.5 Validation Master Plan shall consist of following:
5.5.1 The first page contains details of document, Document Name, Document Number, Organization Name and Logo.
5.5.2 Table of contents:
This page contains list of sections of the Validation Master Plan and the page number on which they start.
5.5.3 Prepared By:
This column shall bare the signature of the persons who have prepared the VMP along with the date. QA Personnel shall prepare the VMP.
5.5.4 Reviewed By:
This column shall bear the signatures of the persons who have reviewed the VMP along with the date. Head Production, Head Engineering Head QA and Head QC/ Designee shall review the VMP.
5.5.5 Approved By:
This column should include the signatures and dates of the individuals who have approved the VMP. QA must approve the VMP.
5.5.6 Objective:
This section outlines the purpose of the Validation Master Plan and the objectives it aims to achieve through its implementation.
5.5.7 Scope:
This section describes the extent to which Validation Master Plan is applicable.
5.5.8 Validation Policy:
This section elucidates the overarching approach and intentions guiding all validation activities to be undertaken by the firm.
5.5.9 Validation Committee:
This section describes about people / team responsible for activities based on the type of validation/ qualification activities undertaken.
5.5.10 Facility and utility qualification:
This section describes about description and approach about utilities available i.e. water system, HVAC, compressed air etc.
5.5.11 Equipment qualification:
This section describes the activities to be covered under qualification/validation, which includes equipment/ instrument with description of activities to be carried out.
5.5.12 Process validation:
This section describes the activities to be covered under process validation, which includes types and brief description of activities to be carried out.
5.5.13 Cleaning validation:
This section describes about the approach of cleaning validation and selection criteria of worst case product collection.
5.5.14 Calibration of instruments:
This section describes about description and approach about of calibration of instrument available.
5.5.15 Analytical method validation:
This section describes about the approach for analytical method to be performed.
5.5.16 Computer and software validations:
This section describes about the approach for computer and software validations to be performed.
5.5.17 Risk analysis:
This section describes about the approach and their methodology for risk analysis to be performed
5.5.18 Vendor qualification:
This section describes about the overall approach for vendor or provisional vendor qualification to be performed.
5.5.19 Personnel qualification:
This section describes about the overall approach for Personnel qualification, person who are working in sterile area and handling of sophisticated equipments
i.e. HPLC, GC etc.
5.5.20 Transit Validation:
This section describes about the overall approach for Transit Validation to be performed.
5.5.21 Maintenance Qualification:
This section describes about the overall approach for preventive maintenance to be performed for Equipments and Instruments.
5.5.22 Validation / Qualification documentation:
This section describes documentation requirements to prepare protocols and reports.
5.5.23 Planning and Scheduling:
This section describes about planning and scheduling of validation activities.
5.5.24 Personnel Training programs:
This section describes about training programme applicable for personnel working in organization.
5.5.25 Change Control and Approvals:
This section describes the actions to be taken if a change is proposed.
5.5.26 Routine / Periodic qualification or validation:
This section describes about approach for Routine / Periodic qualification or validation to be performed.
5.5.27 Re-qualification and Re-validation:
This section describes about Re-qualification and Re-validation approach for equipment, processes, cleaning etc.
5.5.28 Review of validation mater plan:
This section describes about review period of validation master plan.
5.5.29 References:
This section describes about the reference documents related to the Validation master plan.
5.5.30 Annexure:
List the annexure, which are enclosed to VMP.
5.6 Numbering system:
5.6.1 Validation master plan shall be numbered as
VMP/XXX/YYY-ZZ
Where,
VMP- represents validation master plan.
XXX- represents first three digit of the company name.
YYY- represents serial number, which starts from 001.
ZZ- represents version number.
5.7 Review and Revision of Validation Master Plan:
5.7.1 The Validation Master Plan shall be reviewed once in two year or whenever there is a modification, expansion or addition in the existing facility. The same shall be captured through change control.
5.7.2 All the changes made shall be entered in brief in the ‘Change History’ and attached at the end of the VMP. Change history shall indicate all the changes associated with each of the version.
5.7.3 If there are no changes during the review, Change history shall be revised mentioning ‘Review done – No changes required’ under the column changes made and approved in a same way as VMP.
5.7.4 Revalidation of the validated equipment / system / utilities shall be carried out by the supplement qualification protocol.
6.0 ABBREVIATIONS:
VMP :Validation Master Plan.
SOP :Standard Operating Procedure
QA :Quality Assurance.
QC :Quality Control
DQ :Design Qualification
IQ :Installation Qualification
OQ :Operational Qualification
PQ :Performance Qualification
e.g. :Example.
cGMP :Current Good Manufacturing Practice
7.0 REFERENCES:
8.0 LIST OF ANNEXURES:
Nil.
Also read: SOP for management review meeting
Also read: SOP for Change control programme