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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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

Corrective Actions

De­fi­ni­ti­on of the term („What is a cor­rec­ti­ve ac­tion?“)  The ISO 9000 de­scri­bes a cor­rec­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a