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.
The scheme was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. PIC/S states that, as of November 2026, it has 57 participating authorities from Europe, Africa, the Americas, Asia and Australasia. Its stated mission is to lead the international development, implementation and maintenance of harmonised 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 → standards and quality systems of inspectorates in the field of medicinal products.
Two of its guidance documents come up throughout this glossary. PI 011-3, 'Good Practices for Computerised Systems in Regulated GxP 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). Read in the glossary → Environments', is intended as a reference for regulated users, including their suppliers, as well as for regulatory inspectors and investigators. PI 041-1, 'Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments', is addressed to inspectorates: it aims to guide them in interpreting GMP/GDP requirements on good data management and in conducting inspections. PI 041-1 states that it is not mandatory or enforceable under law and is not intended to replace national legislation.
The suppliers PI 011-3 mentions include companies like ours: as a software supplier to pharma companies, we are among the readers it addresses. In our case studies we list the guideline sections relevant to the system in a further-reading section. These references are a signpost to the sources, not a summary, and say nothing about the software described.
Where the term appears
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
Sources
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Introduction (opens in a new tab)
PIC/S accessed
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Mission, Vision and Values (opens in a new tab)
PIC/S accessed