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AN OVERVIEW OF THE

VALIDATION, CALIBRATION AND QUALIFICATION

UNIT – 5

PART TWO

PHARMACEUTICAL QUALITY ASSURANCE

DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY

BIRLA INSTITUTE OF TECHNOLOGY, MESRA

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After watching this video lecture we are going to LEARN:
Definition of validation.
Scope of validation.

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Validation

Introduction

Validation is an integral part of quality assurance: it involves the systematic study of systems, facilities and process aimed at determining whether they perform their intended functions adequately and consistently as specified.

A validated process is one which has been demonstrated to provide a high degree of assurance that uniform batches will be produced that meet the required specifications and has therefore been formally approved.

ISO DEFINITION

Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

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Scope of validation

Validation requires an appropriate and sufficient infrastructure including:

- organization, documentation, personnel and finances

Involvement of management and quality assurance personnel
Personnel with appropriate qualification and experience
Extensive preparation and planning before validation is performed
A specific program for a validation activities in place
Validation done in a structured way according to documentation including procedure and protocols.

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Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions:

What is validation?
what is scope of validation?

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Purposes of Validation

Validation is a must process before introduction of a new method into routine use, whenever the conditions change for which a method has been validated, e.g., instrument with different characteristics.
Whenever the method is changed, and the change is outside the original scope of the method.

VALIDATION IS DONE :
To admit samples to the measurement process.
To minimize later questions on sample authenticity.
To provide an opportunity for resampling when needed.
To accept an individual sample as a member of a population under study.

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Types of Pharmaceutical Validation

PROCESS VALIDATION
EQUIPMENT VALIDATION
CLEANING VALIDATION
ANALYTICAL METHOD VALIDATION

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Prepared by-

ARTI

DR. MANIK GHOSH

PARMACEUTICAL QUALITY ASSURANCE

DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY

BIRLA INSTITUTE OF TECHNOLOGY, MESRA