WHO／最近改訂等されたガイドライン

6/16付GMP Platformトピック「WHO／Guidance on Good Data and Record Management Practices(最終版)を発出」並びに6/8付更新トピック「WHO／各種ガイドラインのウェブサイト」で、WHOのガイドラインについてお伝えしました。
古くは、昨年6/26付「WHOの発出による輸送・保管に関するレポート・ガイドライン」としてもお伝えしました。
 
いくつかのガイドラインについては、最近改訂等が行われたようですので列記します。
興味のあるガイドラインがあればご参照ください。
 
●  WHO good manufacturing practices for biological products
Annex 3, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex03.pdf?ua=1
 
●  Guidance on good manufacturing practices: inspection report, including Appendix 1: Model certificate of good manufacturing practices (revision)
Annex 4, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex04.pdf?ua=1
 
●  Good trade and distribution practices for starting materials (revision)
Annex 6, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex06.pdf?ua=1
 
●  Current projects（進捗中のガイドライン等です）
http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/
 
以下は必ずしも“品質関係”のものではありませんが、2016年改訂のものを列記しておきます。
 
● Collaborative procedure between the World Health Organization (WHO) prequalification team and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines (revision)
Annex 8, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex08.pdf?ua=1
 
●  World Health Organization general guidance on variations to multisource pharmaceutical products Annex 10, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex10.pdf?ua=1
 
● Guidance for organizations performing in vivo bioequivalence studies (revision)
Annex 9, WHO Technical Report Series 936, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex09.pdf?ua=1
 
●  FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products
Annex 2, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex02.pdf?ua=1
 
●  Guidelines on the conduct of surveys of the quality of medicines
Annex 7, WHO Technical Report Series 996, 2016
http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex07.pdf?ua=1