EU GMP guideline

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EU GMP guideline

The EU GMP gui­de­line sum­ma­ri­zes all re­gu­la­ti­ons and ope­ra­ting in­s­truc­tions that have ever been spe­ci­fied for phar­maceu­ti­cal com­pa­nies in the Fe­de­ral Re­pu­blic of Ger­ma­ny. This gui­de­line and all it an­ne­xes are all le­gal­ly binding.

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Glossary overview

GAMP5

GAMP stands for Good Au­to­ma­ted Ma­nu­fac­tu­ring Prac­ti­ce. The num­ber five re­pres­ents ver­si­on 5 which is curr­ent­ly the most up-to-date im­ple­men­ta­ti­on. GAMP5 of­fers a prag­ma­tic and

User Requirement Specification (URS)

De­fi­ni­ti­on of the term („What is an user re­qui­re­ment spe­ci­fi­ca­ti­on?“)  A URS or User Re­qui­re­ment Spe­ci­fi­ca­ti­on con­ta­ins a com­pre­hen­si­ve de­scrip­ti­on of the cus­to­mer re­qui­re­ments with