Patel, P, Patel, NM, Patel, PM (2011) who guidelines on quality control of herbal medicines. Inter J Res Ayurveda Pharm 2: pp. 1148-1154Patel Parthik, Patel N. M and Patel P. M. WHO guidelines on quality control of herbal medicines. IJRAP2011; 2: 1148-1154....
1.7 This document should be read in conjunction with other WHO guidelines as referenced below (2-14), as well as other regulatory guidelines which include The International Council for Harmonisation of Technical Requirements for Pharmaceutical...
12.11 In the case of retention samples, it is acceptable to store information related to the final packaging as written or electronic records if such records provide sufficient information. In the case of reference samples, the system shou...
4.2.1 Thequality of drinking-water is covered by the WHO drinking-water qualityguidelines (5) and standards from the International Organization forStandardization (ISO) and other regional and national agencies. Drinking-watershould comply with the relevant regulations laid down by the competentauthority...
Risk management principles, as described by WHO and other guidelines on quality risk management (10), should be applied to assist in identifying and assessing risks. The appropriate controls should be identified and implemented to mitigate contamination and cross-contamination. ...
2.7. Other guidelines and GxP should betaken into account, where relevant and as appropriate, as to the stages ofdevelopment, production and control of the product. 在产品开发,生产和控制阶段应酌情考虑其他准则和 GxP。 2.8. Proceduresshould be flexible to provide for changes whenever necessary, as...
The WHO Supplementary guidelines on good manufacturing practice: validation were published in 2006 and were supported by seven appendices. The main text and its appendixes were revised between 2006 and 2019. Appendix 3, relating to cleaning validation , was not updated at that time. Its revision,...
_中英文_附录2 WHO药品GMP指南
2.6. The WHOdocument titled Good manufacturingpractices for investigational pharmaceutical products for clinical trials in humans (1) specifically addressesthe requirements and recommendationsfor products used in clinical trials. Other WHO guidelines address specificrequirements and recommendations including but no...
It excludes the production, storage and usage of water in qualit y-control laboratories. 本文重点 在于制药用水 的生产、储存和分配 ,不包括质量控制实验室 用水 的生产、储存和使用。 1.3 This document does not cover water for administration to patients in the formulated state or the use of ...