Lecture 11 Flashcards

1
Q

What is Validation?

A

Validation is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality.

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2
Q

What are the 5 key types of validation?

A

Analytical Method Validation
Computer System Validation and Computer Software Assurance
Equipment and Instruments Qualification and Validation
Cleaning Validation
Process Validation

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3
Q

What is Qualification?

A

Qualification is the demonstration that equipment, utilities, and systems are suitable for their intended use. It is a mandatory requirement in the pharmaceutical industry and is considered part of validation.

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4
Q

What is a Validation Master Plan (VMP)?

A

The Validation Master Plan is a document that outlines the extent of validation work, responsibilities, and the approach to be taken. It provides information on how validation work is organized and may relate to a new product or system.

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5
Q

What are the typical approaches to Validation?

A

Evidence obtained through testing: This includes prospective and concurrent validation.
Analysis of accumulated data: Known as retrospective validation.

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6
Q

What is Concurrent Validation?

A

Concurrent validation is part of prospective validation, where products are distributed during the validation study. For new or modified processes, products should not be distributed until the validation data is reviewed.

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7
Q

What is Retrospective Validation?

A

Retrospective validation involves analyzing historical data. It is rarely used today and mainly for auditing processes, as most products have already undergone prospective validation.

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8
Q

What is Prospective Validation?

A

Prospective validation is performed before a new test or product is released for use or distribution.

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