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Interesting Facts and Explanations of Terms

6 Results found
Blog
Media Fills

Validation of sterile process control The EU GMP (good manufacturing practice) Guideline Part IV “GMP Requirements for ATMP (advanced therapy ...

Blog
Document and data archiving

All types of documents, master documents and those related to processes, plants and devices, must be either in digital form or paper-based and must ...

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National Exemption: Authorization according to § 4b Abs. 3 AMG

Advanced therapy medicinal products (ATMPs) are subject to centralized approval by the European Medicines Agency (EMA) in accordance with Regulation ...

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Technology transfer

Technology transfer describes the transfer of processes or even analytical methods from one environment to another. This can involve the transfer ...

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Supplier qualification

The good manufacturing practice (GMP) environment requires qualification of suppliers to ensure drug quality and safety. The EU GMP Guidelines as ...

Blog
Explanation of terms for biological indicators

D-value/decimal reduction time: Quantity used to describe the resistance of microoranisms. Corresponds to the time in minutes required under certain ...