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T 14 July 2015 Tablets & Capsules excipients Understanding and implementing the new standard for excipient GMP Irwin Silverstein IBS Consulting in Quality Linda Herzog IPEC-Americas With the adoption in 2014 of a new standard governing excip- ients, IPEC-Americas has ramped up its program to educate and train excipient manufacturers, distributors, and users. Now with a new standard—"NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Standard" (NSF/IPEC/ANSI 363) —issued in December 2014, the industry is waiting to see how the FDA might use the standard to help ensure that drugs (components and drug products [1]) are manufactured in conformance with current GMP. Furthermore, in March 2015, the European Commission—acting under Article 46(f) of the European Falsified Medicines Directive (FMD) —issued a guideline "on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use" [2]. It describes how the holder of manufacturing authorization should use risk assessment to determine which GMP is required for each excipient in a drug formulation. he year 2015 could prove a challenging one for mak- ers, users, and distributors of excipients. Since mid-2012, when the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, the FDA has held public meetings, developed guidance, and implemented plans to speed up reviews and access to safe and effective drug products. The Agency continues to seek more stakeholders to help improve the safety of the drug supply chain.