New WHO TRS 992 (May 2015) having guidance on Hold time study, Process validationand stirage & transport of products
14/06/2015 15:58
WHO TRS (T e c h n i c a l R e p o r t S e r i e s) 992 was released in May-2015 by WHO.
This TRS has someuseful guidelines on the following topics as annexure.
Out of these annexure,annex 3 (Guidelines on good manufacturing practices: validation, Appendix 7: non‑sterile process validation), annex 4 (General guidance on hold-time studies) and annex 5 (Technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products) are more useful to industry at this moment.
Forfurther details, please refer: WHO TRS 992