Medicines

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.

Policy on oseltamivir shelf-life expiry
pdf, 145kb

Pharmaceutical development of multisource (generic) finished pharmaceutical products – points to consider
pdf, 828kb

Provision by health-care professionals of patient-specific preparations for children that are not available as authorized products - points to consider
pdf, 486kb

Development of paediatric medicines: points to consider in pharmaceutical development
pdf, 695kb

Report for WHO on findings of a review of existing guidance/advisory documents on how medicines should be administered to children, including general instructions on compounding preparations and manipulation of adult dosage forms
pdf, 1.19Mb

Monograph development for The International Pharmacopoeia
pdf, 146kb

Definition of active pharmaceutical ingredient
pdf, 116kb

WHO Good Manufacturing Practices: Water for pharmaceutical use
pdf, 545kb

WHO guideline on quality risk management
pdf, 583kb

Frequently asked questions about collaborative trials to characterize International Chemical Reference Substances (ICRS)
pdf, 173kb

Guidance on variations to a prequalified product
pdf, 1.36Mb

Monographs and general tests under review/revision for inclusion in the International Pharmacopoeia

2.3 Sulfated ash (revision of the published method)
pdf, 100kb

3.2 Test for sterility (revision of the published method)
pdf, 380kb

5.3 Disintegration test for tablets and capsules (revision of the published method)
pdf, 229kb

5.5 Dissolution test for solid oral dosage forms (revision of the published method)
pdf, 2.28Mb

5.6 Extractable volume for parenteral preparations (revision of the published method)
pdf, 123kb

5.7 Tests for particulate contamination (revision of the published method)
pdf, 288kb

Mefloquine hydrochloride
pdf, 283kb

Paediatric retinol oral solution
pdf, 242kb

Chewable albendazole tablets
pdf, 158kb

Medroxyprogesterone injection
pdf, 177kb

Levonorgestrel and ethinylestradiol tablets
pdf, 188kb

Quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients (APIs)
pdf, 314kb

Tablet friability (revision of the published method)
pdf, 140kb

Daft proposal for inclusion of a general method in the fourth edition of the international pharmacopoeia bulk density and tapped density of powders
pdf, 230kb

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