Trending Process Validation Discussions

What is the difference between evaluation and validation ? ‎

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How to give manufacturing process validation protocol in pharmaceutical? ‎

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How would you validate the cleaning process after producing Anthrax in a fermenter if you plan to follow it with a non spore forming product?‎

This scenario is where only one batch is produced in two to three years and building a separate facility as per GMP guidelines is not financially viable.‎

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Hi, i have a flowmeter installed at the Outlet off a lobe pump with a variation off +- 3% (jelli line).?‎

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Answer added by  Zubeir Patel, Shift Lead Engineer, Jaguar Landrover Halewood Operations
9 years ago

In terms of processes...   1). Evaluation: is determining whether the process in its entirety can yield an output that meets the desired requirements.    2). Validation: ... See More

 

Answer added by  Yasir AL Sammarraie, Field Service Engineer IV, Tokyo Electron
6 years ago

Evaluation is a process to determine if the product or could be an individualon is meeting/not meeting or within the goal/ target or specification of the project or study ... See More

 

Answer added by  Shawal Hameed
6 years ago

First of all we need to define validation for cleaning process. that is nothing but ask yourself Are we performing right clenaing process? Now we need to identify the obj ... See More

 

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

This really hard Question , for my self , I did not work in biotechnology field but if you need brainstorming , We need to agree at first that m.o not like chemicals , no ... See More

 

Answer added by  myriam kanaan, Associate Technical Director, Benta Pharma Industries
10 years ago

What is the question?