WHO／Technical Report Series No.1010（11点のガイドライン）発行

6/15付のGMP Publishingが「WHO: Technical Report Series No.1010 published」と題して、WHOによる「the 52nd Technical Report Series No. 1010」の発行を紹介しています。
 
具体的には、以下の11点のガイドラインが含まれています。
 
GMP関係としては、以下のものが挙げられています。

●WHO guidelines on good herbal processing practices for herbal medicines (Annex 1)
●WHO good manufacturing practices for herbal medicines (revision) (Annex 2)
●Guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems (revision) (Annex 8)
●Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions (Annex 9)
●Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (revision) (Annex 10)
●Considerations for requesting analysis of medicines samples (revision) (Annex 3)
●WHO model certificate of analysis (revision) (Annex 4)
●WHO guidance on testing of “suspect” falsified medicines (Annex 5)
●Good pharmacopoeial practices: Chapter on compounding (Annex 6)
●Good pharmacopoeial practices: Chapter on monographs on herbal medicines (Annex 7)
●Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities (Annex 11).
 
関係者及び興味のある方は、下記URLのニュース記事をご参照ください。
本ニュース記事内には、WHOの「the 52nd Technical Report Series No. 1010」もリンクされています。
https://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/who-trs-1010-2018-52-report-may-published.html