Le département "Essential medicines and health products" de l'OMS a mis à disposition des documents concernant l'Assurance Qualité qui sont des bases de discussion et les experts peuvent proposer des amendements, (cf le site).
Vous trouverez tous les textes à cette adresse :
http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
Par exemple :
Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (QAS/15.639)
pdf, 3.14Mb
Collaborative procedure between the World Health Organization (WHO) Prequalification Team-Medicines and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products1 and vaccines (QAS/15.633)
pdf, 713kb
Guidelines on the conduct of surveys of the quality of medicines (QAS/15.630)
pdf, 753kb
Guidance on good manufacturing practices: Inspection report (QAS/15.625)
pdf, 284kb
WHO certification scheme on the quality of pharmaceutical products moving in international commerce: Q&A (QAS/15.623)
pdf, 519kb
Guidance for organizations performing in vivo bioequivalence studies. Proposal for revision (QAS/15.622/Rev1))
pdf, 819kb
Proposal for revision of good trade and distribution practices for pharmaceutical starting materials (QAS/15.611)
pdf, 323kb
Recommendations on the content of a survey protocol for surveys of the quality of medicines (QAS/14.590)
pdf, 2.72Mb
WHO general guidance on variations to multisource pharmaceutical products (QAS/14.575/Rev.1)
pdf, 397kb
Good pharmacopoeial practices (QAS/13.526/Rev.6)
pdf, 685kb
FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products (QAS/14.582/Rev.1)
pdf, 714kb
Good trade and distribution practices for pharmaceutical starting materials. Revision (QAS/13.552)
pdf, 678kb
QAS/14.598 - Model guidance for the storage and transport of time & temperature-sensitive pharmaceutical products
pdf, 555kb
QAS/14.598 - Consolidated abbreviations and glossary
pdf, 1.02Mb