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.
The glossary of the EU GMP Guide adds that the proof is made in accordance with the principles of GMP GMP 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. Read in the glossary → . The 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 → glossary defines a narrower term, 'qualification', as proving that any equipment works correctly and actually leads to the expected results. It notes that 'validation' is sometimes widened to incorporate qualification.
Annex 11 of the EU GMP Guide and the GDP guidelines both address computerised systems. Annex 11 covers all forms of computerised systems used as part of GMP-regulated activities. It says the application should be validated and the IT infrastructure qualified. It adds that decisions on the extent of validation should be based on a justified and documented risk assessment. Section 3.3.1 of the GDP guidelines asks for appropriate validation or verification studies before such a system goes into use.
Annex 15 of the EU GMP Guide defines, among others, these qualification steps, each a documented verification:
- Installation Qualification (IQ) verifies that facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer's recommendations.
- Operational Qualification (OQ) verifies that they perform as intended throughout the anticipated operating ranges.
- Performance Qualification (PQ) verifies that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.
We do not offer validation for the applications we build (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 → ).
Where the term appears
- Read more Non-GxP in pharma: what we build, what we leave out and where our systems stop
- Read more Pharma IT services: Non-GxP software
- Read more Stock alerts in pharma logistics: the customer asked for a web shop. We thought it through.
- Blog Proof of delivery in pharma logistics: matched to the client, searchable in a portal
- Project rollenrampe.de
- Project FEAS Onlineshop
See also
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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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GMP
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.
Pharma
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GAMP
GAMP, short for Good Automated Manufacturing Practice, is guidance published by ISPE on a risk-based approach to computerised systems in GxP environments.
Pharma
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QA
QA is short for quality assurance; in the EU, both good manufacturing practice (GMP) and good distribution practice (GDP) are defined as part of it.
Pharma
Sources
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EudraLex Volume 4, Glossary (opens in a new tab)
Europäische Kommission, Generaldirektion Gesundheit accessed
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Leitlinien vom 5. November 2013 für die gute Vertriebspraxis von Humanarzneimitteln (2013/C 343/01) (opens in a new tab)
Amt für Veröffentlichungen der EU (EUR-Lex) 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
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EudraLex Volume 4, Annex 15: Qualification and Validation (in Kraft seit 1. Oktober 2015) (opens in a new tab)
Europäische Kommission, Generaldirektion Gesundheit accessed