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Good Manufacturing Practices für Ausgangsstoffe

Aktuelle Entwicklungen

Frank Milek

Aug. Hedinger GmbH & Co. KG, Qualitätssicherung und GMP, Stuttgart

Good Manufacturing Practices for Starting Materials - Recent developments GMP for starting materials expands the requirement, that quality and safety of medicinal products can not only be achieved by quality control, they must be assured by specific quality management systems. The Development of pharmaceutical regulations and the activities of different organisations are showing an increasing importance of GMP principles for the manufacture and distribution of starting materials. Numerous guidelines had been published. They are more and more used by starting materials manufacturers and distributors for the implementation of GMP into their quality systems. GMP for starting materials will have more influence on supplier qualification of pharmaceutical companies in the future and will change quality assurance of these substances on a long term basis. The ongoing development of appropriate and feasible GMP requirements for active pharmaceutical ingredients, excipients and the distribution of starting materials is an important necessity in that context. GMP for starting materials will include suppliers of these products in the responsibility for safety of medicinal products.

Key Words GMP · Ausgangsstoff · Wirkstoff · Hilfsstoff · GMP-Leitfaden