Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency …

Oct 8, 2003 · Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing …

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 …

The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution …

The EU has MRAs on GMP with Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States. All these agreements cover human/veterinary medicines; however the …

Increase efficiency on reporting inspections data and create a better overview of scientific/regulatory data by managing your inspections for GMP, GCP and GVP processes via …

Mar 11, 2025 · The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until …

Principles and guidelines of good manufacturing practice for medicinal products for human use should be set out in relation to quality management, personnel, premises and equipment, …

Feb 19, 2025 · On January 26, 2024, the European Medicines Agency (EMA) published the new ICH Q14 Guideline "Analytical Procedure Development" as Step 5. It has been in force since …

The EMA validates submissions to the centralised system and determines whether or not an inspection of the manufacturing, control, batch release and importation site(s) concerned is …