validation master plan | Scope of validation master plan

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The intent of this Validation Master Plan (VMP) is to provide a written plan for establishing documented evidence of the suitability of the facilities, reliability and consistency of the equipment, and validity of the manufacturing process.

This VMP shall be used during the design and commissioning of a plant. The VMP is a framework for gathering documentation and conducting qualification studies necessary to fulfill fundamental philosophies of Good Manufacturing Practices in pharmaceutical manufacturing, such as:

VALIDATION MASTER PLAN

FIG: VALIDATION

The layouts must:

Ø  Facilitate operations
Ø  Provide appropriate space
Ø  Provide proper flow of materials, people, and waste
Ø  Prevent mix-ups
Ø  Prevent contamination


The materials of construction and environment must:

Ø  Provide ease of cleaning and maintenance
Ø  Prevent bacterial growth or infestation
Ø  Provide temperature, humidity, and particulate control
Ø  Not be a source of contamination

The utilities and equipment operations must:

Ø  Perform within specified tolerances and limits
Ø  Demonstrate control and reliability
Ø  Be easily and thoroughly cleaned
Ø  Prevent contamination
Ø  Have instrumentation, controls, and procedures for proper operation and records

The packaging equipment and operations must:

Ø  Not deteriorate or contaminate drug product
Ø  Prevent mix-ups
Ø  Maintain integrity of containers
Ø  Provide tampers evident packing where appropriate

The warehouse and materials handling systems must:

Ø  Keep all materials under strict control
Ø  Provide ability to identify and track any ingredient, material, in-process drug, or finished product
Ø  Provide temperature, humidity, and lighting control suitable for all materials and products
Ø  Provide secure transit and quarantine of in-process or finished drug products waiting for QC release
Ø  Provide facilities for incoming material sampling



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