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(2016; 46 pages)
During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines’ manufacturing held by the World Health Organization (WHO) in Geneva in April 2014, a proposal for new guidance on good data management was discussed and its development recommended. The participants included national inspectors and specialists in the various agenda topics, as well as staff of the Prequalification Team (PQT)–Inspections.
The WHO Expert Committee on Specifications for Pharmaceutical Preparations received feedback from this informal consultation during its forty-ninth meeting in October 2014. A concept paper was received from PQT– Inspections describing the proposed structure of a new guidance document, which was discussed in detail. The concept paper consolidated existing normative principles and gave some illustrative examples of their implementation. In the Appendix to the concept paper, extracts from existing good practices and guidance documents were combined to illustrate the current relevant guidance on assuring the reliability of data and related GXP (good (anything) practice) matters...