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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Enterprise Content Management System (ECM)

De­fi­ni­ti­on of the term (“What is ECM?”)  ECM is the ab­bre­via­ti­on of En­ter­pri­se Con­tent Ma­nage­ment. This is the ma­nage­ment of all data and in­for­ma­ti­on ge­ne­ra­ted in

Preventive Actions

De­fi­ni­ti­on of the term („What are pre­ven­ti­ve ac­tions?“) The ISO 9000 de­scri­bes a pre­ven­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a detected