6 Results found
03.04.2024
Media Fills
Validation of sterile process control The EU GMP (good manufacturing practice) Guideline Part IV “GMP Requirements for ATMP (advanced therapy ...
02.04.2024
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 ...
02.04.2024
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 ...
02.04.2024
Technology transfer
Technology transfer describes the transfer of processes or even analytical methods from one environment to another. This can involve the transfer ...
02.04.2024
Supplier qualification
The good manufacturing practice (GMP) environment requires qualification of suppliers to ensure drug quality and safety. The EU GMP Guidelines as ...
02.04.2024
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 ...