WHOのガイドラインについて、12/4現在として2020年に制改訂されたものをピックアップしてみました。
ちみに、パブコメ中のもの、ドラフト作成中のものは含めていません。
また、一部については、別トピックとしてお伝えしたものもあります。
【Production】
l「IAEA - WHO good manufacturing practices for radiopharmaceutical products」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex2.pdf?sfvrsn=7aceb0c1_6
l「Production of water for injection by means other than distillation」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex3.pdf?sfvrsn=caebed51_4
l「Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex6.pdf?sfvrsn=c947184b_2
【Distribution】
l「WHO good storage and distribution practices for medical products」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex7.pdf?sfvrsn=9b8f538c_2
l「Points to consider for setting the remaining shelf-life of medical products upon delivery」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex8.pdf?sfvrsn=dfb3eca3_2
【Inspections】
l「Quality system requirements for national good manufacturing practice inspectorates」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex5.pdf?sfvrsn=910c5942_2
l「WHO guidelines on pre-approval inspections」
https://www.who.int/docs/default-source/medicines/norms-and-standards/current-projects/trs902-annex7-preapprovalinspections.pdf?sfvrsn=64a91595_2
【Quality control】
l「WHO good chromatography practices」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex4.pdf?sfvrsn=53f56dbc_4
l「The International Pharmacopoeia: Procedure for the development of monographs and other texts」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/quality-control/trs1025-annex1-in-pha-procedure-development-monographs.pdf?sfvrsn=1d63e73c_0
l「UNFPA-WHO technical specifications for male latex condoms」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex10.pdf?sfvrsn=e9a028d1_2
l「UNFPA-WHO specifications for plain lubricants」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex11.pdf?sfvrsn=3dd1e3bb_2
l「WHO guidelines for sampling of pharmaceutical products and related materials」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/quality-control/trs929-annex4-guidelinessamplingpharmproducts.pdf?sfvrsn=f6273f30_2
【Regulatory standards】
l「UNFPA-WHO technical specifications for male latex condoms」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex10.pdf?sfvrsn=e9a028d1_2
l「UNFPA-WHO specifications for plain lubricants」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex11.pdf?sfvrsn=3dd1e3bb_2
l「IAEA - WHO good manufacturing practices for radiopharmaceutical products」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex2.pdf?sfvrsn=7aceb0c1_6
l「WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex12.pdf?sfvrsn=f875ed4b_2
l「WHO guidelines on the implementation of quality management systems for national regulatory authorities」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/prequalification/trs1025-annex13.pdf?sfvrsn=2fe3b8d_2
【Prequalification guidance texts】
l「WHO guidelines on the implementation of quality management systems for national regulatory authorities」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex13.pdf?sfvrsn=8e6a17ee_2
l「UNFPA-WHO prequalification programme guidance for contraceptive devices: Male latex condoms, female condoms and intrauterine devices」
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/trs1025/trs1025-annex9.pdf?sfvrsn=bddf6763_2
ちみに、パブコメ中のもの、
また、一部については、
【Production】
l「IAEA - WHO good manufacturing practices for radiopharmaceutical products」
https://www.who.int/docs/
l「Production of water for injection by means other than distillation」
https://www.who.int/docs/
l「Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance」
https://www.who.int/docs/
【Distribution】
l「WHO good storage and distribution practices for medical products」
https://www.who.int/docs/
l「Points to consider for setting the remaining shelf-life of medical products upon delivery」
https://www.who.int/docs/
【Inspections】
l「Quality system requirements for national good manufacturing practice inspectorates」
https://www.who.int/docs/
l「WHO guidelines on pre-approval inspections」
https://www.who.int/docs/
【Quality control】
l「WHO good chromatography practices」
https://www.who.int/docs/
l「The International Pharmacopoeia: Procedure for the development of monographs and other texts」
https://www.who.int/docs/
l「UNFPA-WHO technical specifications for male latex condoms」
https://www.who.int/docs/
l「UNFPA-WHO specifications for plain lubricants」
https://www.who.int/docs/
l「WHO guidelines for sampling of pharmaceutical products and related materials」
https://www.who.int/docs/
【Regulatory standards】
l「UNFPA-WHO technical specifications for male latex condoms」
https://www.who.int/docs/
l「UNFPA-WHO specifications for plain lubricants」
https://www.who.int/docs/
l「IAEA - WHO good manufacturing practices for radiopharmaceutical products」
https://www.who.int/docs/
l「WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms」
https://www.who.int/docs/
l「WHO guidelines on the implementation of quality management systems for national regulatory authorities」
https://www.who.int/docs/
【Prequalification guidance texts】
l「WHO guidelines on the implementation of quality management systems for national regulatory authorities」
https://www.who.int/docs/
l「UNFPA-WHO prequalification programme guidance for contraceptive devices: Male latex condoms, female condoms and intrauterine devices」
https://www.who.int/docs/
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