Validation

Validation of an activity is the provision of

documented evidence that the activity function in
accordance with its design and will continuously
produce the intended result with in the predefined
specification.

Goals of Process Validation.

The goals of are to determine the

Suitability of the process.

Uniformity of the process
Reproducibility of the process

Types of Validations

Prospective Validation:

The documented evidence, prior to a process

implementation, that a process does what it purports to
do based on a validation master plan.

All new facilities or operations must be validated before

release of product.

Retrospective Validation:

The documented evidence that a process does what

it purports to do based on review and analysis of
historical information.

Existing facilities and operations that have not been

prospectively validated must be assessed against an
approved Validation Master Plan and appropriate action
initiated.

Concurrent Validation:

The documented evidence that a process does what

its purports to do based on information generated
during actual implementation of the system.

Out line of Validation Activity

1. Validation Master Plan

2. Validation Plans
3. Responsibility
4. Validation Protocols
5. Equipment Qualifications
6. Equipment Calibration
7. Documentation
8. Standards Operating Procedures
9. Deviations
10. Change Control
11. Validation Report
12. Documents Retention & Retrieval

Benefits of Validation

Most common deficiencies cited during Quality

Audit/Inspections are:

Laboratory Controls 15%

Equipment Cleaning 14%

Process Controls 13%

Decimation 11%

9%
 Water System 9%

Others 25%

Validation helps in reducing the number of batch

rejected/recalls.

Reduce cost by reducing cycle time.

Supports in gaining market reputation and leadership.

It gives a higher quality, more uniform and reproducible

products.

Develops confidence among the patients and health

profession.

Boosts employee morale and motivation.

Conclusion

The concept of Validation is of vital importance in cGMP.

Variations due to materials, machines, methods and men
should be properly evaluated and controlled so as to produce
products of consistent quality.

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