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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EU GMP Guidelines Chapter 7

Chap­ter 7 “Out­sour­ced Ac­ti­vi­ties” of the EU GMP Gui­de­li­nes deals with the re­spon­si­bi­li­ties of the con­trac­tor and con­trac­ting en­ti­ty in the case of out­sour­ced activities.