my research project is on Pharmaceutical Process Validation during tablet manufacturing and I want to know the techniques, methods, ways, and materials required for it. Any papers related to it?
You have to validate material, equipment, process like granulation, compression etc. Then you have to validate the release profile i.e. dissolution procedure. By following these steps you will come to final conclusion.
Also read the Annex 15 of EU GMP
(https://www.google.hu/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwi5itC72dfZAhWFvRQKHV1wBb4QFggnMAA&url=https%3A%2F%2Fec.europa.eu%2Fhealth%2Fsites%2Fhealth%2Ffiles%2Ffiles%2Feudralex%2Fvol-4%2F2015-10_annex15.pdf&usg=AOvVaw1OKtHb2CM0vjT2wlP4tNZN)
Generally what you need is the following:
1) have a manufacturing process
2) know what the quality requirements of the product are (e.g.: weigth, size, hardness, friability, disintegration, assay, CU, dissolution, degradation products, etc.)
3) have compendial or validated analytical procedures
4) justify the quality requirements by performing (at least) 3 consecutive batch production, thorough sampling (at least 5 time points during manufacture) and testing all batches, all samples
5) write down everything, because GMP = Give More Paper :)
Hi Naheen,
I lead the process tech specialist team at an SOD manufacturing site, and we take care of all product and process related projects, including validation studies, and I can tell you that there is no one way of carrying out process validation.
If you wish to contact me for specific details, you can find me on linked-in: https://www.linkedin.com/in/mark-zammit-b2b1475a/
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