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8 paź 2003 · Find the latest guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use in the European Union. Download the PDF documents for each chapter, annex and related document.
Learn about the EU standards and guidance for medicines manufacturing and distribution. Find out how EMA coordinates inspections, harmonises GMP activities and provides legal framework and Q&As.
The Guide presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of the typical requirements for various validation studies.
This document is a revision of the WHO draft text on GMP for medicines and pharmaceutical specialities, published in 1967 and 1971. It covers the general concepts of quality assurance, the subsystems of GMP, the actions to be taken by production and quality control personnel, and the certification scheme.
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 ...
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.
This document provides nonbinding recommendations for the good manufacturing practice (GMP) of APIs and intermediates. It covers topics such as quality management, personnel, buildings and facilities, equipment, documentation, materials management, production and in-process controls, packaging and labeling, and testing.
