This has changed now with the publication of the good automated manufacturing practice gamp forums good practice guide gpg on validation of laboratory computerized systems 1 however this publication needs to be compared and contrasted with the aaps publication on qualification of analytical instruments aiq 2 both publications have . Recently updated to conform with gampr 5 concepts and terminology as well as recent regulatory and industry developments the ispe gampr good practice guide a risk based approach to gxp compliant laboratory computerized systems second edition contains steps that scientists suppliers and others involved in managing laboratory computerized . Gmp news 24 may 2005 new gamp good practice guide validation of laboratory computerized systems published the gamp forum has published the new gamp good practice guide validation of laboratory computerized systems this document which has been designed especially for computerised systems in analytical laboratories in a gmp glp or gcp regulated environment is a complement to the gamp . The gamp good practice guide on the validation of laboratory computerized systems is one such guide that was published in 2005 12 the major problem with analytical instruments that are used in a regulated laboratory is their great variety complexity and variations in intended use. Gamp guidance ispe has published a series of good practice guides for the industry on several topics involved in drug manufacturing the most well known is the good automated manufacturing practice gamp guide for validation of automated systems in pharmaceutical manufacturethe last major revision gamp5 was released in february 2008
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