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FDA Compliance Program 7356.002M, Inspections of Licensed Biological Therapeutic Drug Products, 09/06 2021-09-21T07:17:56+00:00January 17th, 2020|
ICH Guideline, Development and Manufacture of Drug Substances, Q11, Questions and Answers, 02/18 2020-02-18T11:32:20+00:00November 20th, 2019|
EMA Guidance for the template for the qualified person’s declaration concerning GMP compliance The QP declaration template, 05/14 2020-02-04T10:16:17+00:00November 20th, 2019|
ICH Guideline: GMP Guide for API – Q7 – Questions and answers 06/15 2019-11-20T11:11:04+00:00November 20th, 2019|