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44th Expert Committee on Specifications for Pharmaceutical Preparations

Geneva, 12-16 October

Working documents

For submissions of comments please use the following forms...

:: Example form [pdf 48kb]
:: Submission form [doc 54kb]

Quality Assurance

:: Proposal for revision of WHO good distribution practices for pharmaceutical products [pdf 595kb]
(including measures against penetration of counterfeits into the legitimate supply chain)
:: WHO guideline on transfer of technology [pdf 529kb]
:: Guidelines for the preparation of a contract research organization master file (CROMF) [pdf 140kb]
:: Guideline on the requalification of prequalified dossiers [pdf 182kb]
:: WHO good practices for pharmaceutical quality control laboratories [pdf 840kb]
:: WHO good manufacturing practices for sterile pharmaceutical products proposal for revision [pdf 578kb]
:: Good manufacturing practices for pharmaceutical products containing hazardous substances [pdf 404kb]

The International Pharmacopoeia

ARVs

:: Indinavir capsules [pdf 168kb]
:: Lopinavir and ritonavir tablets [pdf 151kb]
:: Saquinavir tablets [pdf 190kb]
:: Tenofovir tablets [pdf 198kb]
:: Tenofovir disoproxil fumarate [pdf 200kb]
:: Lopinavir [pdf 211kb]

General monographs

:: Capsules [pdf 219kb]
:: Tablets [pdf 290kb]

Malaria

:: Amodiaquine tablets [pdf 141kb]
:: Artesunate [pdf 219kb]
:: Artesunate tablets [pdf 215kb]
:: Quinine bisulfate tablets [pdf 221kb]

Tuberculosis

:: Amikacin sulfate injection [pdf 168kb]
:: Amikacin sulfate [pdf 257kb]
:: Amikacin [pdf 213kb]
:: Kanamycin acid sulfate [pdf 194kb]
:: Kanamycin monosulfate [pdf 240kb]
:: Kanamycin sulfate injection [pdf 120kb]

Radiopharmaceuticals

:: Fludeoxyglucose (18f) injection [pdf 90kb]
:: Gallium (67ga) citrate injection [pdf 53kb]
:: Iobenguane (123i) injection [pdf 60kb]
:: Iobenguane (131i) injection [pdf 121kb]
:: Samarium (153sm) ethylenediamine tetramethylene phosphonate (edtmp) complex injection [pdf 98kb]
:: Sodium iodide (131i) capsules [pdf 115kb]
:: Sodium iodide (131i) injection [pdf 54kb]
:: Sodium iodide (131i) solution [pdf 46kb]
:: Sodium (125i) iothalamate injection [pdf 132kb]
:: Sodium pertechnetate (99mtc) injection (fission) [pdf 81kb]
:: Sodium pertechnetate (99mtc) injection (non-fission) [pdf 59kb]
:: Sodium phosphate (32p) injection [pdf 120kb]
:: Strontium (89sr) chloride injection [pdf 126kb]
:: Technetium (99mtc) bicisate complex injection [pdf 391kb]
:: Technetium (99mtc) succimer complex injection [pdf 151kb]
:: Technetium (99mtc) exametazime complex injection [pdf 312kb]
:: Technetium (99mtc) mebrofenin injection [pdf 157kb]
:: Technetium (99mtc) medronate complex injection [pdf 129kb]
:: Technetium (99mtc) mertiatide complex injection [pdf 160kb]
:: Technetium (99mtc) pentetate complex injection [pdf 62kb]
:: Technetium (99mtc) tin pyrophosphate complex injection [pdf 129kb]
:: Technetium (99mtc) sestamibi complex injection [pdf 175kb]
:: Technetium (99mtc) colloidal sulfur injection [pdf 126kb]
:: Technetium (99mtc) tetrofosmin complex injection [pdf 172kb]
:: Technetium (99mtc) colloidal tin injection [pdf 127kb]
:: Thallous (201tl) chloride injection [pdf 58kb]
:: Yttrium (90y) silicate injection [pdf 112kb]