本帖最后由 roadman 于 2018-8-16 16:37 编辑
http://www.pharmaguideline.com/2014/07/how-effectively-execute-validation-protocol.html
1. Specificationsand the limits in the protocol should be correct and should meet the realprocess results. The actual process of manufacturing, sampling procedure and test method mustbe written in validation protocol. 2. Protocolsshould be written in easy to understand language and training to the concerneddepartments should be given before the execution of the validationprotocol. 3. The protocolshould be written by the qualified person and should have the completeknowledge of the process being validated. 4. A trial runshould be executed before the actual validation run. This trial run should betreated as an actual validation run. This shall help all persons to be familiarwith the validation process beforethe actual validation process. 5. Trial runresults should be calculated and documented to find the errors in theimplementation of the validation protocol, those shall help in the actualimplementation of the validation protocol. 6. Results of thetrial run should be reviewed by the qualified person of theconcerned department. 7. Availability ofthe all required equipment, instruments and accessories should be ensuredbefore starting the validation activity. 8. All criticalprocesses like dispensing, sifting, blending, drying, sampling and calculationsetc. must be cross-checked by the quality assurance. 9. Any deviation or abnormalthing should be documented immediately otherwise you can forget the details ofthe incidence. 10. Observation onevery step should be written by the quality assurance to get the authenticvalidation results.
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