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.
The EU GDP guidelines do not define quality assurance as such. Their glossary defines the quality system: the sum of all aspects of a system that implements quality policy and ensures quality objectives are met. For manufacturers, Commission Directive (EU) 2017/1572 defines the pharmaceutical quality system as the organised arrangements to ensure medicinal products are of the quality required for their intended use. Chapter 1 of the EU GMP Guide 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 → uses that term for consistency with ICH Q10, an international guideline defining it as the management system to direct and control a pharmaceutical company with regard to quality.
Under section 1.2 of the GDP guidelines 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 → , management should appoint a responsible person for the quality system. Section 3.3.2 says evidence of satisfactory validation 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. Read in the glossary → and acceptance should be produced and approved by appropriate personnel; it names no specific department. Annex 15 of the EU GMP Guide says qualification and validation staff should report as the pharmaceutical quality system defines, not necessarily to a quality assurance function. It also calls for appropriate quality oversight of the whole validation lifecycle.
On our pages, QA means the operator's quality assurance team, which is responsible for the quality system, classifies systems and checks what we supply. Classification starts with that team talking to us; we then supply everything it needs, in the format it requires.
Where the term appears
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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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
Sources
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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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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, 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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ICH guideline Q10 on pharmaceutical quality system, Step 5 (EMA/CHMP/ICH/214732/2007, Fassung September 2015) (opens in a new tab)
European Medicines Agency (EMA) 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