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  1. www.ema.europa.eu › en › human-regulatory-overviewGood manufacturing practice | European Medicines Agency (EMA)

    Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP. GMP requires that medicines: are of consistent high quality; are appropriate for their intended use; meet the requirements of the marketing authorisation or clinical trial authorisation.

  2. www.ema.europa.eu › en › human-regulatory-overviewGuidance on good manufacturing practice and good distribution...

    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. The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation ...

  3. health.ec.europa.eu › medicinal-products › eudralexEudraLex - Volume 4 - European Commission - Public Health

    8 paź 2003 · Part IV - GMP requirements for Advanced Therapy Medicinal Products. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products; Other documents related to GMP and GDP. Compilation of Union Procedures on Inspections and Exchange of Information

  4. www.ema.europa.eu › en › documentsReflection Paper on Good Manufacturing Practice and Marketing ...

    This Reflection Paper seeks to provide clarity on these. In relation to maintaining the supply of medicinal products, the EU medicines legislation, as well as the GMP Guide, place obligations upon the MAH that relate to the supply of its medicinal products and to the maintenance of such supply.

  5. health.ec.europa.eu › latest-updates › eudralex-volume-4-eu-guidelines-goodEudralex Volume 4 - EU Guidelines for Good Manufacturing Practice...

    21 lut 2022 · Eudralex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. News announcement. 21 February 2022. Directorate-General for Health and Food Safety. 1 min read.

  6. www.fda.gov › files › drugsQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical...

    This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for...

  7. health.ec.europa.eu › system › filesThe Rules Governing Medicinal Products in the European Union...

    This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (MIA) holder, when importing medicinal products (human, investigational and veterinary) from outside the EU/EEA.