GAMP

According to 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 011-3, the Pharmaceutical Industry Systems 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 → Forum in the UK developed the GAMP Supplier Guide to help software suppliers implement an appropriate quality management system. GAMP is one of ISPE ISPE Founded in 1980, ISPE (the International Society for Pharmaceutical Engineering) describes itself as a not-for-profit association leading scientific, technical and regulatory advancement in pharma. 's Communities of Practice. The ISPE GAMP 5 Guide, Second Edition, is titled 'A Risk-Based Approach to Compliant 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 → Computerized Systems'. In ISPE's words, it maintains the principles and framework of the first edition and updates their application.

ISPE says GAMP aims to deliver a framework of good practice to ensure that computerised systems are effective and of high quality, fit for intended use and compliant with applicable regulations. It describes the approach as patient-centric and risk-based. ISPE's page 'What is GAMP?' adds that GAMP does not define a prescriptive method or a standard, but provides pragmatic guidance, approaches and tools for the practitioner. GAMP is industry guidance, not law.

For the systems 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 → ), we give the operator's QA team 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. Read in the glossary → something concrete to check: automated tests, security testing and traceability matched to the system's purpose. For traceability, for example, a change history shows each logged change, who made it and when.