SOP for Preparation of Validation Master Plan (VMP)

1.0 OBJECTIVE:

To lay down the procedure for preparation of Validation Master Plan (VMP).

The intent is to provides a road map for validation to establish FDA requirements master validation procedures, validation program, execution protocols, and resources planning and scheduling.

2.0 SCOPE:

This standard Operating Procedure (SOP) applies for the preparation of validation master plan covering all the validation aspects implemented and planned at [company name].

3.0 RESPONSIBILITY:

QA Personnel: To prepare the Validation Master Plan, ensure and control of schedule.                         

All HODs: To ensure validation / calibration schedule is followed. To contribute as a member in Validation Core Committee

Head QA:

To contribute as a member in Validation Core Committee.

To approve the validation master plan

Built the validation Task force in coordination with other Department heads.

4.0 PROCEDURE:

4.1 The content of validation master plan shall include but not limited to following:

4.1.1 Approval Page

4.1.2 Introduction to [Company]

4.1.3 Introduction to Validation Master Plan (VMP)

4.1.4 Purpose

4.1.5 Scope

4.1.6 Definitions

4.1.7 Manufacturing Facility

 Quality Control / Quality Assurance Facility

 Warehouse

 Production Capacity

4.1.8 Facility Design (General Design)

 Civil structure, Design and Finishing

4.1.9 Plant Utilities

 Chilled Water Generation and Distribution System

 Steam Generation and Distribution system

 Raw water Generation and Distribution System

 Drainage System

 Diesel Generator (D.G.) Set

 Dust Collector

 Door Interlock

 Flames Fumes Detector system

4.1.10 Process Utilities

 HVAC System

 Purified water Generation and Distribution system

 Compressed Air Generation and Distribution system

4.1.11 Manufacturing

 Gowning

 Personnel Entry and Exit in Manufacturing facility

 Staff Entry to the Process area

 Staff Exit from the Process area

 Material Entry and Material Handling

 Equipment Maintenance

 Calibration

 Equipment Cleaning

 Garment Washing

4.1.12 Personnel

 Recruitment

 Training

 Hygiene

4.1.13 Change Control

4.1.14 Standard Operating Procedure and Documentation

4.1.15 Validation

 Validation Overview

 cGMP / cGLP Review

 Documentation

 Validation Policy

 Machines

 Identification of Vendors

 Pre-qualification Acceptance Test

4.1.16 Design Qualification (DQ)

4.1.17 Protocol Preparation and Approval, Calibration Programme.

4.1.18 Installation Qualification (IQ)

4.1.19 Operational Qualification (OQ)

4.1.20 Performance Qualification (PQ)

4.1.21 Final Report

4.1.22 Re-validation

4.1.23 Analytical Method Validation

4.1.24 Materials

4.1.25 Responsibility

4.1.26 Qualification Summary

 Steam Generation and Distribution system

 HVAC System

 Purified Water System

 Compressed Air circulation and Distribution System

 Equipment / Instruments in Raw Material / Packaging material Warehouse and Finished Goods

 Equipment / Instruments in Tablet / Capsule Processing Facility

 Equipment / Instruments in Quality Control Facility

4.1.27 Cleaning Validation

4.1.28 Optimization Batches

4.1.29 Qualification / Exhibit batches

4.1.30 Process Validation

4.1.31 Prospective Validation

4.1.32 Concurrent Validation

4.1.33 Retrospective Validation

4.1.34 Computer System Validation

4.1.35 Validation Aspect

4.1.36 Abbreviations

4.1.37 Schedules and Flow Charts

4.2 The details content of validation master plan shall include following:

4.2.1 Approval Page: The approval page shall include the signature and date of the personnel from engineering, quality control, production and Quality Assurance department. VMP is shall be authorized by Unit Head.

4.2.2 Introduction to [Company]: This part shall include the brief detail information on the organization describing the regulatory credential available at each location along with other related information.

4.2.3 Introduction to Validation Master Plan (VMP): This shall includes the definition of validation and validation master plan with brief description.

4.2.4 Purpose: This part shall provide the reasons why the VMP is intended to be prepared and followed.

4.2.5 Scope: This part shall provide the information on the area of application of VMP to give assurance that system and equipment are in compliance with cGMP requirement.

4.2.6 Definitions: This section shall be provided with all the relevant definition applicable to Validation, Calibration and Qualification activity. i.e. VMP, Calibration, Qualification, etc.

4.2.7 Manufacturing Facility: This part shall provide the brief details about the layout of the plant and its major section and further description of each section.

4.2.8 Facility Design (General Design): This part shall includes the information on civil structure its construction and its designing and finishing.

4.2.9 Plant Utilities: This part shall give brief description of the various utilities provided in the plant for manufacturing the quality products. The description may include the capacity of each equipment, any identification mark for that utility and any other special performance characteristic.

4.2.10 Process Utilities: This part shall also give brief description of the various utilities (such as compressed air, Purified water system, Heating Ventilation and Air conditioning (HVAC)) provided in the plant for manufacturing the quality products. The description may include the capacity of each equipment, any identification mark for that utility and any other special performance characteristic.

4.2.11 Manufacturing: This part shall include the various aspects that is required to be covered during manufacturing process. Starting from entry into the manufacturing area to exit from the manufacturing area. This shall includes the briefs regarding the gowning applicable, entry exit route both in process area and non process area, material entry and handling, cleaning and maintenance of the equipment, and etc.

4.2.12 Personnel: This part shall include the brief description regarding recruitment criteria and procedure for new personnel, their training procedure and information on personel hygiene that is to be given to each individual.

4.2.13 Change Control: Information regarding the change monitoring system shall be given in order to ensure the assessment of the effectiveness of the changes in cGMP and product quality.

4.2.14 Standard Operating Procedure and Documentation: This part may include the list of important sop’s existing in quality assurance department and brief description on the documentation procedure.

4.2.15 Validation: This part includes validation overview giving the documented evidence that facility, equipment, process, system are in compliance with cGMP. It may cover the vendors and machine validation procedure.

4.2.16 Qualification: This part includes the brief description of various qualification study for equipment / instruments such as Design qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Final report and Revalidation. This shall enlist the minimum documentation that is required during executing the qualification study. After the completion of the qualification activity the final report shall be prepared to summarize the results. The part shall include the criteria for carrying out the Re-validation activity.

4.2.17 Analytical Method Validation: This part shall include the brief description about the analytical method validation preformed by Analytical development laboratory(ADL) in conjunction with location Quality control unit.

4.2.18 Materials: This part shall includes the information on the approved vendor providing the Raw material and Packaging material and procedure for approving the vendor.

4.2.19 Responsibility: This part shall give the information on the personnel involved in the different validation activity such as protocol preparation, report preparation, etc.

4.2.20 Qualification Summary: This part shall include the summary of qualification status i.e. Installation, Operational and Performance (Which ever applicable) of various Process and Plant utilities.

4.2.21 Cleaning Validation: This part shall provide the policy for cleaning validation activity that is to be carried out for the product manufactured in the area.

4.2.22 Optimization, Qualification and Exhibit batches: This shall include procedure followed for the validation activity to be carried out. The process parameters shall be optimized and the shall be targeted in the subsequent batch and further exhibited.

4.2.23 Process Validation: This part shall include the brief description of the validation procedure for the manufacturing procedure and various aspects of validation such as prospective validation, concurrent validation, retrospective validation and re-validation. This shall give description regarding the protocol preparation, approval, execution, and final report preparation. This shall also give the criteria for validating the procedure and re-validation.

4.2.24 Computer System Validation: This shall include the brief description regarding the computer system validation to ensure high degree of confidence, accuracy, consistency and reliability. This shall cover the various aspects of software and hardware components.

4.2.25 Abbreviation: There shall be a section describing the various abbreviation i.e. short forms that are applicable and used during preparation of VMP.

4.2.26 Schedules and Flow Charts: This part shall include the list of various attachments and drawings (if available) in conjunction with VMP. The proposed schedules for validation and calibration shall be prepared pertaining for the various equipment / Instruments available in the plant.

4.3 Based on the above-mentioned index, guidance the preparation of validation master plan shall be preceded.

4.4 Any changes in the VMP shall be addressed by preparation of Addendum (If the changes are Significant) or in the subsequent revision.

4.5 The verification of execution of the schedules for validation and calibration shall be done periodically during the Internal audits.

5.0 ANNEXURE (S):

Nil