we are facing lots of issues whenever we are trying to validate our process either for new formulation or change formulations due to the lack of pilot scale facility. which cause many process related issues such as blending time variations, poor flow properties of granules, many other compression issues etc etc etcss.
To nullify these issue I have been suggested to my heads that we have to first optimize the initial batch with more extensive then regular validation sampling and testing procedures, that’s why my title is Process validation cum Process optimization, and then after successfully optimization on commercial scale we do validate our process.
I am attaching a drafted document for your valuable comments on it .
I am keen to read your suggestions. please comments.
My name is Tony Newcombe and I am a Principal Consultant with PAREXEL. Previously I worked as Head of Process & Product Validation at GSK and spent a nuber of years as part of the technical leadership team at Pfizer.
I’ve read your document posted on-line with interest and have a few comments that I would be happy to share, but perhaps you would prefer for me to send these on to you privately? Feel free to drop me an email if this is of interest: anthony.newcombe@parexel.com.
Best wishes
Tony
PAREXEL International
Dear Experts,
we are facing lots of issues whenever we are trying to validate our process either for new formulation or change formulations due to the lack of pilot scale facility. which cause many process related issues such as blending time variations, poor flow properties of granules, many other compression issues etc etc etcss.
To nullify these issue I have been suggested to my heads that we have to first optimize the initial batch with more extensive then regular validation sampling and testing procedures, that’s why my title is Process validation cum Process optimization, and then after successfully optimization on commercial scale we do validate our process.
I am attaching a drafted document for your valuable comments on it .
I am keen to read your suggestions. please comments.