EU GMP Guideline Annex 11

An­nex 11 of EU GMP gui­de­li­ne. It de­scri­bes re­qui­re­ments for all kinds of com­pu­te­ri­zed sys­tems used as part of GMP-re­gu­la­ted ac­ti­vi­ties.
A com­pu­ter-ba­sed sys­tem is a com­bi­na­ti­on of soft­ware and hard­ware com­pon­ents which tog­e­ther ful­fill cer­tain func­tions. The ap­p­li­ca­ti­on should be va­li­da­ted, the IT in­fra­st­ruc­tu­re should be qualified.

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Process audit

De­fi­ni­ti­on of the term (“What is a pro­cess au­dit?”)  The term pro­cess au­dit de­scri­bes the eva­lua­ti­on of the qua­li­ty ca­pa­bi­li­ty for pro­ducts, pro­duct groups and

GxP

All gui­de­li­nes for good working prac­ti­ce, which are par­ti­cu­lar­ly im­portant in me­di­ci­ne, phar­ma­cy and phar­maceu­ti­cal che­mi­stry, are sum­ma­ri­sed by the ab­bre­via­ti­on GxP. The “G” stands for