Intermediates
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Annex 2 W HO good manufacturing practices for active ...
www.who.int17.2 Traceability of distributed APIs and intermediates 17.3 Quality management 17.4 Repackaging, relabelling and holding of APIs and intermediates 17.5 Stability 17.6 Transfer of information 17.7 Handling of complaints and recalls 17.8 Handling of returns 18. Specifi c guidance for APIs manufactured by cell culture/fermentation 18.1 General
Dear Prof. Daugulis - University of Houston
olafs.chem.uh.eduintermediates and protecting intellectual property. I am confident that the valuable experience and the insight gained so far will enable me to contribute to the research interests of your group and provide the necessary impetus to establish myself in …
Assessment report on the annual renewal of the conditional ...
www.ema.europa.euInformation and justification on critical steps and intermediates (including specifications) should be provided. July 2021 . 26/07/2021 . Ongoing . SO4 (e) Specified impurities should be further evaluated and appropriate specification limits for individual imp urities should be included when more data are available.
Guideline on the requirements for the chemical and ...
www.ema.europa.euGuideline on the requirements for the chemical and p harmaceutical quality documentation concerning investigational medicinal products in clinical trials