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Eudralex -  European Communities

Eudralex

Rules Governing Medicinal Products in the European Union
Buch | Softcover
143 Seiten
1998 | 1997 ed
European Commission (Verlag)
978-92-828-2029-2 (ISBN)
CHF 26,95 inkl. MwSt
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This guide to medicinal products features chapters headed by a principle of GMP, outlining the Quality Assurance objectives of that chapter and a text which aims to provide sufficient detail for manufacturers to be made aware of essential matters to be considered when implementing the principle.

Directives. Good manufacturing practices. Basic requirements: quality management; personnnel; premises and equipment; documentation; production; quality control; contract manufacture and analysis; complaints and product recall; self inspection.

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