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. Actual process of manufacturing, sampling procedure and test method must be written in validation protocol.
3. 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 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 equipments, 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 quality assurance to get the authentic validation results.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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