Transcription of EN - gmp-compliance.org
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EUROPEAN. COMMISSION. Brussels, C(2022) 5938 final GUIDELINES. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use EN EN. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 1. Manufacture of Sterile Medicinal Products Legal context for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC. on the Community code relating to medicinal products for human use and Regulation 2019/6. on the Community code relating to veterinary medicinal products.
Aug 25, 2022 · Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommend that the current version of annex 1, on the manufacture of sterile medicinal products, is revised to reflect changes in regulatory and manufacturing environments.
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