Trending Validation Discussions

How do you process validation on a pharmaceutical project? ‎

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Answer added by  ABDALLA EMADALDEEN ALOLABI, Coordinator for ‎Technical ‎Affairs, CityPharm Pharmaceutical Industry
6 years ago

I advice you to start from  Euorpean medicins health giudeline 29 March 2012 (Guideline on Process Validation) then biuld your master plan then protocols then reports Fol ... See More

 

Answer added by  Mohamed Elhibishy, QA Manager, Pioneer Co. For Pharmaceuitical Industry
6 years ago

First you need to issue Master validation plan , according to PIC/S and then proceed in issueing protocols for every validation / calibration process , Implement the vali ... See More

 

Answer added by  Mahmoud Abdel Aal Ahmed, QA manager, Organo Pharma
6 years ago

Make Risk assesment for process, follow HACCP to detect critical points and then detect critical control points, set up the parameters and specifications of CCPs and vali ... See More

 

Answer added by  ashfaq ali, Regulatory Affairs Specialist/Quality Assurance Supervisor , Alrazi Pharma Industries
6 years ago

Follow risk based approch (by Failure Effect Mode Analysis) to find out the process critical parameters and validate these parameters and conclude routine control measure ... See More