Current projects
The following list of items represents the work that is currently underway within the Quality Assurance team:
New texts under review for medicines quality assurance
Should you have any comments thereon please send these as requested in the box on the first page of each document. You will need to use a downloaded/copied version of the table for comments.
-
Draft working document: Proposal for revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation (QAS/13.527)
pdf, 344kb -
FIP-WHO Technical guidelines: Provision by health-care professionals of children-specific preparations that are not available as authorized products - points to consider (QAS/13.525)
pdf, 562kb -
guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part (QAS/13.522)
pdf, 1.35Mb -
General guidance for inspectors on "hold-time" studies (QAS/13.521)
pdf, 197kb -
Good pharmacopoeial practices concept paper on purpose and benefits (working document QAS/13.518/Rev.1)
pdf, 187kb
-
FIP-WHO technical guidelines: Considerations on the provision by health-care professionals of patient-specific enteral compounding for special populations (for example, paediatric and geriatric patients) when no suitable authorized products are available (QAS/12.509)
pdf, 536kb -
Model quality assurance system for procurement agencies (MQAS) (QAS/12.508)
pdf, 1.12Mb