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GMP/GDP and GCP

EMA updates guidance in forms of questions and answers (Q&A) on Good manufacturing practice / Good distribution practice and Good Clinical practise

The European Medicines Agency’s (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP), good distribution practice (GDP) and good clinical practise (GCP) as discussed and agreed by the GMP/GDP and GCP Inspectors Working Group. The guidance provided by the working groups in the form of questions and answers (Q&As) provides additional interpretation of the European Union (EU) guidelines published by the European Commission. The working group prepares these Q&As as the need arises.

Recently, EMA has updated its list of questions and answers on Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) and Good Clinical practise (GCP):

  • newly added chapter from February 2022 deals with the requirements for active substances used as starting materials in veterinary medicinal products. There are altogether 6 questions and answers available on the EMA website and question two explains the new obligations of the Veterinary Medicines Regulation that now requires manufacturers and importers of veterinary medicinal products to verify that manufacturers, importers and distributors within the Union from whom they source the active substances have registered their activities in the territory of the Member State where they are established and perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.
  • newly added chapter from March 2022 deals with Good Clinical Practice as discussed and agreed by the GCP Inspectors Working Group. All together eight questions were updated on the investigational medicinal products (IMP’s) in bioavailability and bioequivalence trials, GCP Matters and Records of Subject Study Data relating to Clinical Trials.