OMS-Bonnes pratiques de fabrication: eau pour préparations pharmaceutiques

Filename GMPWatePharmaceuticalUseTRS970Annex2.pdf
Filesize 322 KB
Version 2012
Date added 4 avril 2014
Downloaded 158 times
Category Bonnes pratiques de fabrication, Fabrication et contrôle qualité
Tags bonnes pratiques, BPF, fabrication, GMP, production

The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU),guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on good manufacturing practices (GMP) regarding the design, installation and operation of pharmaceutical water systems. Although the focus of this document is on water for pharmaceutical applications, the guidelines may also be relevant to other industrial or specific uses where the specifications  and practices can be applied.

Note: this document does not cover water for administration to patients in the formulated state or the use of small quantities of water in pharmacies to compound individually prescribed medicines.

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