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In January 2017, FDA's Office of Pharmaceutical Quality revised the document "MAPP 5310.7" on the acceptability of standards from alternative compendia. This important FDA document is often unknown among the pharmaceutical industry. Learn more about the most important aspects of FDA's document "Acceptability of Standards from Alternative Compendia (BP/EP/JP)".
In March the CMDh published a new Q&A document to provide further guidance on the implementation of the EU Falsified Medicines Directive. Please find more information about the "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".
Insufficient environmental monitoring as well as inexistent smoke studies on a RABS (Restricted Access Barrier System) resulted in a Warning Letter for the Japanese manufacturer Sato Pharmaceutical Co. Ltd.
It is also possible to apply for a Certificate of Suitability for API mixtures. However, a few particularities have to be considered. Here, you can read about what must be observed when applying for a CEP for an API/auxiliary substances mixture or an API/antioxidant mixture.
It its cGMP regulations for medical devices (21 CFR 820 (Quality System Regulations), the FDA also addresses the topic of validation (21 CFR 820.75). In the course of its inspections, the authority reviews the validation of the manufacturing processes. The FDA criticised according deficiencies at a Taiwanese medical devices manufacturer with a Warning Letter.