Good manufacturing practice (GMP) is the part of quality assurance ensuring that medicinal products are consistently produced, imported and controlled to standards appropriate to their intended use.
Commission Directive (EU) 2017/1572 sets out this definition. It covers medicinal products for human use whose manufacture or import requires an authorisation under Article 40 of Directive 2001/83/EC. The European Commission collects its GMP guidelines in EudraLex Volume 4, the EU GMP Guide, which contains references to the applicable legislation and guidance for interpreting GMP for human and veterinary medicinal products. Chapter 1 of the guide says GMP applies across the lifecycle: from the manufacture of investigational medicinal products, via technology transfer and commercial manufacturing, through to product discontinuation.
For software, the relevant part of the guide is Annex 11, which applies to all forms of computerised systems used as part of GMP-regulated activities. For data, the PIC/S guidance PIC/S PIC/S, the Pharmaceutical Inspection Co-operation Scheme, describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicines. Read in the glossary → document PI 041-1 is meant to help inspectorates interpret GMP and GDP GDP Good distribution practice (GDP) is the part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain. Read in the glossary → requirements on good data management. It expects the operator's inventory of computerised systems to include an assessment of each system's function and criticality, with direct GMP/GDP impact, indirect impact and no impact as example levels (see Non-GxP Non-GxP Non-GxP describes a system that its operator does not classify as GxP-relevant; PIC/S guidance uses the term without defining it formally. Read in the glossary → ).
What we build for the pharma sector ranges from an ordering platform for promotional material Promotional material Promotional material is our term for a pharma manufacturer's brochures, pens, posters, displays and other items to promote or inform, requested by its sales staff, medical practices or pharmacies. Read in the glossary → to software with which a logistics provider collects proofs of delivery from carriers and sorts them by client.
Where the term appears
See also
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GxP
GxP is an umbrella term for the good practice guides and requirements of the regulated pharmaceutical sector, such as good manufacturing practice (GMP) and good distribution practice (GDP).
Pharma
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GDP
Good distribution practice (GDP) is the part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain.
Pharma
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Validation
In the EU GMP and GDP glossaries, validation is the action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results.
Pharma
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PIC/S
PIC/S, the Pharmaceutical Inspection Co-operation Scheme, describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicines.
Pharma
Sources
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Richtlinie (EU) 2017/1572 der Kommission vom 15. September 2017 (Grundsätze und Leitlinien der Guten Herstellungspraxis für Humanarzneimittel) (opens in a new tab)
Amt für Veröffentlichungen der EU (EUR-Lex) accessed
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EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines (opens in a new tab)
Europäische Kommission, Generaldirektion Gesundheit accessed
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EudraLex Volume 4, Chapter 1: Pharmaceutical Quality System (in Kraft seit 31. Januar 2013) (opens in a new tab)
Europäische Kommission, Generaldirektion Gesundheit accessed
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EudraLex Volume 4, Annex 11: Computerised Systems (Revision 1, in Kraft seit 30. Juni 2011) (opens in a new tab)
Europäische Kommission, Generaldirektion Gesundheit accessed