![]() GAMP4 Validation Installation Qualification Operational Qualification Performance Qualification All from GAMP4 glossary Validation – difference between ‘testing’ and ‘validation’ is that you can test without either documenting the result or verifying against pre-determined specification Installation qualification – activities such as checking equipment powers up, communicates etc Operational qualification – activities from loop testing, control of individual valves, motors, etc through to run-throughs of sequences Performance qualification – typically requires test batches to be produced in order to check quality attributes are metĦ Jargon continued… Calibration – “The set of operations which establish, under specified conditions, the relationships between values indicated by a measuring instrument, or values represented by a material measure or a reference material, and the corresponding values of a quantity realised by a reference standard.” Change Control – “A formal process by which qualified representatives of appropriate disciplines review proposed or actual changes to a computer system. Performance Qualification – “Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment. Operational Qualification - “Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges”. ![]() A set of guidelines for both users and suppliers – MORE LATER! Validation – “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes” Installation Qualification – “Documented verification that a system is installed according to written and pre-approved specifications”. GAMP4 – “Good Automated Manufacturing Practice” as defined in the GAMP4 Guide for Validation of Automated Systems. ![]() GCP Good Clinical Practice GDP Good Distribution Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice GxP All of the above!! Sometimes cGxP with ‘c’ for ‘current’ URS User Requirements Specification VMP Validation Master Plan IQ Installation Qualification OQ Operational Qualification PQ Performance Qualification SOP Standard Operating Procedure All from GAMP4 acronym list GAMP4 launched in Amsterdam 3& Re-running sessions at ISPE Birmingham conference May if anyone missed out and wants to attendĤ Lots of Nasty Acronyms GCP GDP GLP GMP GxP URS VMP IQ OQ PQ SOP The scope has been expanded to cover automated systems within Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP) in addition to the original Good Manufacturing Practice (GMP) environment. 3 GAMP Guide History 1994 – UK Pharmaceutical Industry Computer System Validation Forum set up (now known as the GAMP forum) 1994 – First draft issued 1995 – Vers– Vers– Vers– Version 4 With GAMP4, the target audience has been expanded from just pharmaceuticals to the whole healthcare industry including biotechnology and medical devices.
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