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Guidelines on principles of GDP for active substances for medicinal products for human use. (link is external) The Good manufacturing practice (GMP) / GDP Inspectors Working Group provides additional interpretation of the EU GMP and GDP guidelines in the form of questions and answers (Q&As).
- Guidance on good manufacturing practice and good distribution practice ...
The European Medicines Agency's (EMA) provides answers to...
- Good manufacturing practice | European Medicines Agency (EMA)
Good manufacturing practice (GMP) describes the minimum...
- EudraLex - Volume 4 - European Commission - Public Health
Part IV - GMP requirements for Advanced Therapy Medicinal...
- Good Manufacturing and Distribution Practices
The authorisation holder must comply with the principles and...
- Guidelines of 5 November 2013 on Good Distribution Practice of ...
The Commission has published EU Guidelines on Good...
- Guidance on good manufacturing practice and good distribution practice ...
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.
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
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
The authorisation holder must comply with the principles and guidelines of good manufacturing practice and use active substances (active pharmaceutical ingredients) which were manufactured in compliance with GMP. The relevant legal requirements are outlined below.
The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 (2). Revised guidelines were published in March 2013 (3) in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive
29 paź 2024 · Due to the restrictions caused by COVID-19, the period of validity of GMP and GDP certificates issued by EEA authorities is automatically extended until the end of 2024, except where clarifying remarks in the document state otherwise.
