Category: Questions & Answers QC

Question & Answer on Quality Control Part -III AS PER EU Guidelines (EudraLex) Question: What is the purpose of the ongoing stability programme for medicinal products according to the EU GMP? Answer: The purpose of the ongoing stability programme is to monitor the product over its shelf life and ensure that it remains, and can…

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Question & Answer on Quality Control Part II AS PER EU Guidelines (EudraLex) Question: What validation is required for testing methods according to the EU GMP? Answer: Testing methods should be validated. If a laboratory is using a testing method for which it did not perform the original validation, it should verify the appropriateness of…

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Question & Answer on Quality Control AS PER EU Guidelines (EudraLex) Question: What does Quality Control involve, and why is its independence from Production considered fundamental? Answer: Quality Control encompasses sampling, specifications, testing, organization, documentation, and release procedures to ensure that necessary tests are conducted, and materials or products are not released until their quality…

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