QC
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USFDA
Sathyanarayana M.Sc.
November 14, 2022
What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products?
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![Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhyr9bvNFF5_P3_nApDEsXqmH6fjZ_DH8z_enteilYCF6UduqfoPWFbwrrEIxhCsXkERFtUvSVzrRUJ3DeTGEgOpD-oD00Q9rZJ7tIQXG__eLSKIUQS5tcM2PUtzq6t44umH1rc8rXxt96158_E0k5e-BtD1oVeOmEYxFDk9Z499kr2h9worFcIAYW6/w72-h72-p-k-no-nu/process%20validation%20batches%20(1).jpg)
USFDA
Sathyanarayana M.Sc.
November 04, 2022
Does CGMP regulations require three successful process validation batches before a new API or a finished drug product is released for distribution?
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![FDA Process Validation Guidance 2011: General Principles and Practices](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNkC7IWRMuCe4IhtZCfRuLmA4mJG6yTgY83VMqZXs3un834DsXQG2nMoGqUHxR2jQmTlR7ZF4z4Y0iT67nVP5b6nujUhTl9Ah-0T4243oxvJ5H-rXlDwyG-WZ9VSoXhfpwLNawhZQPNQdHBz5zn2AshD87sXrzLX9vdlP5bK_Nojr1bh_hVc4hsRcz/w72-h72-p-k-no-nu/FDA%20(2)%20(1).jpg)
USFDA
Sathyanarayana M.Sc.
November 04, 2022
FDA Process Validation Guidance 2011: General Principles and Practices
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![Should acceptance criteria for residues be defined for dedicated equipment?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhJJnoYoe0hEhKCoPpXUv0gdu2urUXVeZiwo_AOJ4bDScMhRips69iBQg2sC9m6WQ5DhKi12XRSwFo8doEt2d30hvM8NlOza4UziwqHzCo_BVuiSF-fpbwIl1O9GCfTWlwkGxLQqM8qss19Kc4fNjs8ez_cqiFwKc37obZsEk95YYPAmAgU6ZCoHTHf/w72-h72-p-k-no-nu/Dedicated%20equipment%20(1)%20(1).jpg)
QC
Sathyanarayana M.Sc.
October 31, 2022
Should acceptance criteria for residues be defined for dedicated equipment?
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![Does ICH Q7 expect that the quality unit performs API release testing?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjNLGetRbSNqcQE4O0w4ZhUUWXlxMnznCLHMZtg2o1WpYnrYBgRHToIzbhZxusHE-8vg2CGFSUmd75777eWJ5hsBd8NPR32OHzBKgYcAOyV3cMGS6ByONEHCPy6ocAMOGzAe_y6ed8Sk017WPhSJBMSvin8uPMi4gJEW9xgLqoAxAwDGnCO7b6X2EMH/w72-h72-p-k-no-nu/API%20Testing%20(1).jpg)
QC
Sathyanarayana M.Sc.
October 21, 2022
Does ICH Q7 expect that the quality unit performs API release testing?
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![Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjv6Ts3ldzxFmtaQS9HMVXGE0nqZU8Lk3UPF47hRQ2mBzHvlYVF8hc5KZINfBh3TD8-hG9EDRUyNSXaN4mAnhbDFbQvk1d94WTwhmOfowPFQ3hOCOVLm5QlFcrv_poVBOcnYwtY622W9SN8MV1U2hH1tQS5WRb5emTWHi1YsJPCnHW_IVFT2vk03SDDkeI/w72-h72-p-k-no-nu/warehouse.jpg)
USFDA
Sathyanarayana M.Sc.
September 09, 2022
Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse?
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USFDA
Sathyanarayana M.Sc.
July 22, 2022
Why does the FDA inspect and what does an FDA inspector do?
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