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VALIDATION

 

Validation is an integral part of quality assurance; it involves the systematic study of system, facilities and process aimed at determining whether they perform their intended function 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.

 

 Validation in itself does not improve processes but confirms that

the processes have been properly developed and are under control.

• Definitions According to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adequate validation is beneficial to the manufacturer in many ways:

 

• It deepens the understanding of processes; decreases the risk of

preventing problems and thus assures the smooth running of the process.

• It decreases the risk defect costs.

• It decreases the risk of regulatory noncompliance.

• Fully validated process may require less in-process controls and end

product testing.

 

Validation should thus be considered in the following situations:

 

• Totally new process;

• New equipment;

• Process and equipment which have been altered to suit changing

priorities; and

• Process where the end-product test is poor and an unreliable indicator of

product quality

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 qualifications and experience

• Extensive preparation and planning before validation is performed

• Validation should be performed:

  for new premises, equipment, utilities and systems, and processes and procedures;

  aperiodic intervals; and

  when major changes have been made.

• Validation in accordance with written protocols.

• Validation over period of time, e.g. at least three consecutive batches (full

  production scale) to demonstrate consistency. (Worst case situations should be

  considered.)

• Significant changes (facilities, equipment, processes) - should be validated

• Risk assessment approach used to determine the scope and extent of validation

  Needed.

Importance of Validation

 

1. Assurance of quality

2. Time bound

3. Process optimization

4. Reduction of quality cost.

5. Minimal batch failures, improved efficiently and productivity.

6. Reduction in rejections.

7. Increased output.

8. Fewer complaints about process related failures.

9. Reduced testing in process and in finished goods.

10. More rapid and reliable start-up of new equipment

11. Easier maintenance of equipment.

12. Improved employee awareness of processes.

13. More rapid automation.

14. Government regulation (Compliance with validation requirements is

necessary for obtaining approval to manufacture and to introduce new

products)