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).
GxP means the compliance requirements for all good practice disciplines in the regulated pharmaceutical supply chain, from discovery to post-marketing. PIC/S 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 → , an informal co-operative arrangement between regulatory authorities, defines it this way in the list of abbreviations of its guidance document PI 011-3. The WHO guideline on data integrity calls GxP an acronym for a group of good practice guides for regulated pharmaceuticals, biologicals and medical devices. Its examples show what the 'x' stands for: good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice 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 → (GMP), good pharmacovigilance practices (GVP) and good distribution practice 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 → (GDP).
GxP is not confined to production. PI 011-3 names procurement, inventory control, storage and distribution among the activities that might be GxP-related, and says the list is not exhaustive.
When commissioning software, it pays to establish early whether the system will touch GxP-regulated processes. Another PIC/S guidance document, PI 041-1, expects the regulated user, the company operating the system, to keep an inventory of its computerised systems including an assessment of each system's function and criticality. Direct, indirect and no GMP/GDP impact are example levels, not a yes-or-no record.
That assessment is not ours to make: our business applications Business application In general terms, a business application is software used to perform or support business functions. Read in the glossary → are intended for settings that the operator has classified as 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 → (see Non-GxP). We do not issue certificates of GxP compliance.
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
- Blog Straight to the patient, without ever touching their data
- Blog Ordering promotional material without losing control
- Blog Stock alerts in pharma logistics: the customer asked for a web shop. We thought it through.
- Blog Out of the inbox: a knowledge platform for a pharma logistics provider
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- Page total10 - software for e-commerce and pharma
See also
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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.
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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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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Introduction (opens in a new tab)
PIC/S accessed
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WHO Technical Report Series No. 1033, Annex 4: Guideline on data integrity (2021) (opens in a new tab)
World Health Organization (WHO) 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