Eudralex volume 4 good manufacturing practice gmp guidelines. Unter gute herstellungspraxis englisch good manufacturing practice, abgekurzt gmp versteht man richtlinien zur. With news, trainings and conferences, a comprehensive guidelines database, publications and more the eca is the leading european training and information services provider in the gmp and gdp environment. Good distribution practices for pharmaceutical products trs no. Gmp training, gmp guidelines, gmp trends eca academy. Replacement of commission directive 956ec of june 1991 to cover good manufacturing practice of investigational medicinal products. Volume 4 of the rules governing medicinal products in the european union contains guidance for the interpretation of the principles and guidelines of good. These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.
The most wellknown is the good automated manufacturing practice gamp guide for validation of automated systems in pharmaceutical manufacture. Ispe has published a series of good practice guides for the industry on several topics involved in drug manufacturing. Good manufacturing practice for medicinal products for human and veterinary use commission europeenne. Ecma good manufacturing practice guide ecma gmp leitlinie deutsche ubersetzung 1. Kapitel 4 dokumentation bundesgesundheitsministerium.
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