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

ISO certification

De­fi­ni­ti­on of the term („What does ISO cer­ti­fi­ca­ti­on mean?“) The ISO cer­ti­fi­ca­ti­on is a pro­cess de­si­gned to pro­ve the com­pli­an­ce with cer­tain re­qui­re­ments. For example,

Device Master Record (DMR)

De­fi­ni­ti­on of the term („Was is a De­vice Mas­ter Re­cord?“) A De­vice Mas­ter Re­cord is a tech­ni­cal pro­duct file with com­pi­la­ti­on of re­cords which includes