The European Medicines Agency’s (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.

European Union (EU) GMP guidelines and GDP guidelines

The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation of the European Union (EU) GMP guidelines and GDP guidelines published by the European Commission. The working group prepares these Q&As as the need arises.

EMA may remove individual Q&As when the European Commission updates relevant guidelines.

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