How to Effectively Execute a Validation Protocol?

Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.

Following tips will help in a smooth execution of a validation protocol:

1. Specifications and the limits in the protocol should be correct and should meet the real process results. The actual process of manufacturing, sampling procedure and test method must be written in validation protocol.

2. Protocols should be written in easy to understand language and training to the concerned departments should be given before the execution of the validation protocol.

3. The protocol should be written by the qualified person and should have the complete knowledge of the process being validated.

4. A trial run should be executed before the actual validation run. This trial run should be treated as an actual validation run. This shall help all persons to be familiar with the validation process before the actual validation process.

5. Trial run results should be calculated and documented to find the errors in the implementation of the validation protocol, those shall help in the actual implementation of the validation protocol.

6. Results of the trial run should be reviewed by the qualified person of the concerned department.

7. Availability of the all required equipment, instruments and accessories should be ensured before starting the validation activity.

8. All critical processes like dispensing, sifting, blending, drying, sampling and calculations etc. must be cross-checked by the quality assurance.

9. Any deviation or abnormal thing should be documented immediately otherwise you can forget the details of the incidence.

10. Observation on every step should be written by the quality assurance to get the authentic validation results.

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