Good manufacturing practices (GMP) guidelines: the rules governing medicinal products in the European Union; EudraLex volume 4 concise references/ [author/editor: Mindy J. Allport-Settle].

Overview and orientation -- Introduction -- Commission Directive 20-3/94/EC -- Part I: Basic requirements for medicinal products -- 1.Quality management -- 2.Personnel -- 3.Premises and equipment -- 4.Documentation -- 5.Production -- 6.Quality control -- 7.Contract manufacture and anlysis -- 7.Contract manufacture and analysis -- 8.Complaints and product recall -- 9.Self-inspection -- Part II.Basic requirements for active substances used as starting materials -- Annex 1.Manufacture of sterile medicinal products -- Annex 2.Manufacture of biological medicinal products for human use -- Annex 4.Manufacture of veterinary medicinal products other than immunological veterinary medicinal products -- Annex 5.Manufacture of immunological veterinary products -- Annex 6.Manufacture of medicinal gases -- Annex 7.Manufacture of herbal medicinal products -- Annex 8.Sampling of starting and packaging materials -- Annex 9.Manfuacture of liquids, creams and ointments -- Annex 10.Manufacture of pressurised metered dose aerosol preparations for inhalation -- Annex 11.Computerised systems -- Annex 12.Use of ionising radiation in the manufacture of medicinal products -- Annex 13.Manufacture of investigational medicinal products -- Annex 14.Manufacture of medicnal products derived from human blood or plasma -- Annex 15.Qualification and validation -- Annex 16.Certification by a qualified person and batch release -- Annex 17.Parametric release -- Annex 18 -- Annex 19.Reference and retention samples -- Annex 20.Quality risk management.