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

Complaint management

De­fi­ni­ti­on of the term („What is a com­p­laint?“) A com­p­laint ma­nage­ment in­clu­des all mea­su­res ta­ken by a com­pa­ny to pro­cess cus­to­mer com­p­laints about the company’s

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