GMP Audit Checklist provide the guidance and checkpoint for conducting the GMP audit of the manufacturing facility. The Main areas are covered:-

1.0 Building and Facilities 

2.0 Materials Management

3.0 Quality Control Systems

4.0 Manufacturing

5.0 Packaging and Identification Labelling

6.0 Quality Management Systems

7.0 . Personnel and Training

8.0 Purchasing and Customer Service

9.0 . Retained Samples

10. Non-conforming products management

11.0 Complaints vigilance

12.0 Distribution

13.0 Sub-contractors

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1.0 OBJECTIVE

This Validation Master Plan is written to describe [Site Name, Location] intention and approach towards validation in achieving the objective of providing quality product. This Validation Master Plan shall serve as a summary of the overall strategy for the validations to be executed in the facility to demonstrate that the critical equipment, systems and processes perform as designed and intended.

2.0 SCOPE

This VMP addresses the all-validation activities related to equipment, utilities, processes, systems and procedures that may impact the product quality at the manufacturing blocks of [Site Name, Location], Goa. Specific systems, equipment, utilities and procedures to be qualified and processes (listed below) to be validated shall be exercised on basis of approved qualification / validation protocol. 

• Utilities (HVAC, Compressed Air, Water)

• Equipment / Instrument

• Product Manufacturing Process

• Cleaning Process

• Sterilization Process

• Computer and Computerized Systems (PLC, SCADA, LIMS, SAP etc.)

5.0 VALIDATION APPROACH

This Validation Master Plan shall follow lifecycle validation approach to validate product manufacturing and other auxiliary processes. This approach shall ensure quality from the very first step. This Validation Master Plan shall provide guidance and directions for development of requirements, specifications and actions to qualify and finally accept and release the equipment, system, facilities and validated process for use. The VMP shall also provide guidance on life cycle management of equipment, system and process.

The life cycle approach involves a series of activities taking place over the life cycle of the equipment, system, product and process. The VMP describes the activities in three basic stages:

Stage 1 - Design: The equipment, system and process are defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2 – Qualification / Validation: During this stage, the design is evaluated to determine if it is capable of reproducible performance.

Stage 3 – Continued Verification: Ongoing assurance is gained during this phase that the equipment, system and process remain in a state of control.

A brief flow of product and equipment / facility / utility lifecycle is as below:

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