A3P

Connexion

The current guideline needs to be updated to reflect imminent changes in European Pharmacopoeia. The text of guideline needs to be updated to take into account manufacturing practices using methods other than distillation for producing water of injectable quality and the consequent deletion of the monograph Water, highly purified. A new Ph. Eur. monograph “Water for preparation of extracts” (2249) is also published. 

The objective of the Guideline is to provide guidance to the Industry on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products for human and veterinary use. 

The intention of the revision is to be in line with the revised Ph. Eur. monograph for Water for Injections (0169) and the consequent future deletion of the monograph Water, highly purified (1927). 

The monograph (0169) revision is the result of extensive consultations with stakeholders. 

 

→ Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)

 

logo a3p-100pxhaut

 fren

S'engager pour partager
Transmettre et progresser ensemble
Promouvoir l'innovation

L’Association A3P est un acteur incontournable de l’industrie pharmaceutique et biotechnologique. 
Créée en 1986, elle contribue au bon développement de la production de médicaments et de matériels propres et stériles, elle anime un réseau de 21 000 professionnels, fabricants et fournisseurs, dans le cadre de Congrès internationaux et de journées techniques.

Elle regroupe aujourd’hui plus de 1700 adhérents qui partagent leurs expériences techniques, scientifiques et réglementaires.

 + d'infos en vidéo ( version gb ici )


  group    Administrateurs A3P
    
& Chargés de missions

letter   Newsletter A3P