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Expert Committee on Specifications for Pharmaceutical Preparations
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printable version
44th Expert Committee on Specifications for Pharmaceutical Preparations
Geneva, 12-16 October
Working documents
For submissions of comments please use the following forms...
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Example form [pdf 48kb]
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Submission form [doc 54kb]
Quality Assurance
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Proposal for revision of WHO good distribution practices for pharmaceutical products [pdf 595kb]
(including measures against penetration of counterfeits into the legitimate supply chain)
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WHO guideline on transfer of technology [pdf 529kb]
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Guidelines for the preparation of a contract research organization master file (CROMF) [pdf 140kb]
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Guideline on the requalification of prequalified dossiers [pdf 182kb]
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WHO good practices for pharmaceutical quality control laboratories [pdf 840kb]
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WHO good manufacturing practices for sterile pharmaceutical products proposal for revision [pdf 578kb]
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Good manufacturing practices for pharmaceutical products containing hazardous substances [pdf 404kb]
The International Pharmacopoeia
ARVs
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Indinavir capsules [pdf 168kb]
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Lopinavir and ritonavir tablets [pdf 151kb]
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Saquinavir tablets [pdf 190kb]
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Tenofovir tablets [pdf 198kb]
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Tenofovir disoproxil fumarate [pdf 200kb]
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Lopinavir [pdf 211kb]
General monographs
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Capsules [pdf 219kb]
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Tablets [pdf 290kb]
Malaria
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Amodiaquine tablets [pdf 141kb]
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Artesunate [pdf 219kb]
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Artesunate tablets [pdf 215kb]
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Quinine bisulfate tablets [pdf 221kb]
Tuberculosis
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Amikacin sulfate injection [pdf 168kb]
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Amikacin sulfate [pdf 257kb]
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Amikacin [pdf 213kb]
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Kanamycin acid sulfate [pdf 194kb]
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Kanamycin monosulfate [pdf 240kb]
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Kanamycin sulfate injection [pdf 120kb]
Radiopharmaceuticals
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Fludeoxyglucose (18f) injection [pdf 90kb]
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Gallium (67ga) citrate injection [pdf 53kb]
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Iobenguane (123i) injection [pdf 60kb]
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Iobenguane (131i) injection [pdf 121kb]
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Samarium (153sm) ethylenediamine tetramethylene phosphonate (edtmp) complex injection [pdf 98kb]
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Sodium iodide (131i) capsules [pdf 115kb]
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Sodium iodide (131i) injection [pdf 54kb]
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Sodium iodide (131i) solution [pdf 46kb]
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Sodium (125i) iothalamate injection [pdf 132kb]
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Sodium pertechnetate (99mtc) injection (fission) [pdf 81kb]
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Sodium pertechnetate (99mtc) injection (non-fission) [pdf 59kb]
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Sodium phosphate (32p) injection [pdf 120kb]
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Strontium (89sr) chloride injection [pdf 126kb]
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Technetium (99mtc) bicisate complex injection [pdf 391kb]
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Technetium (99mtc) succimer complex injection [pdf 151kb]
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Technetium (99mtc) exametazime complex injection [pdf 312kb]
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Technetium (99mtc) mebrofenin injection [pdf 157kb]
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Technetium (99mtc) medronate complex injection [pdf 129kb]
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Technetium (99mtc) mertiatide complex injection [pdf 160kb]
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Technetium (99mtc) pentetate complex injection [pdf 62kb]
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Technetium (99mtc) tin pyrophosphate complex injection [pdf 129kb]
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Technetium (99mtc) sestamibi complex injection [pdf 175kb]
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Technetium (99mtc) colloidal sulfur injection [pdf 126kb]
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Technetium (99mtc) tetrofosmin complex injection [pdf 172kb]
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Technetium (99mtc) colloidal tin injection [pdf 127kb]
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Thallous (201tl) chloride injection [pdf 58kb]
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Yttrium (90y) silicate injection [pdf 112kb]
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