Expanded Excipient Services to Help Companies Demonstrate Compliance with cGMP Regulations

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), a non-profit trade association, has agreed to sell IPEA, its wholly owned Excipient Auditing and Certification subsidiary, to NSF International. This will position NSF International as a leader in the excipient auditing arena and will enable NSF to develop new service offerings and deliver excipient, food additive and dietary supplement ingredient audits together.

The FDA continues to closely monitor drug manufacturing supply chains since there have been several public health incidents, including patient deaths, linked to tainted raw materials used in the manufacture of finished drug formulations. US and European regulations require excipients to be safe and functional and to comply with GMP requirements for their manufacture and supply. CFDA in China and Anvisa in Brazil are also issuing regulations in this area.

IPEC develops quality, safety and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEA was founded in 2000 as a wholly owned subsidiary of IPEC-Americas to provide third-party audits of the facilities and systems used to manufacture and distribute pharmaceutical excipients according to the IPEC-PQG (Pharmaceutical Quality Group) GMPs. IPEA’s Excipient GMP Conformance Certification Program is reportedly the only ANSI (American National Standards Institute) accredited provider of excipient GMP certification.

NSF International is a global independent public health organisation that writes standards, tests and certifies products, and offers training and auditing to the food, water and health sciences industries to minimise adverse health effects. As a member of IPEC, NSF International shares IPEA’s long-standing commitment to excipient safety. IPEA will become part of the NSF Health Sciences Division, which offers GMP and GLP testing and certification, and will now include additional third-party audits and certification based on the IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. The division also provides training, auditing and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product lifecycle.

Pharmaceutical manufacturers of both prescription and OTC drugs are responsible for assuring the quality, safety and supply chain of excipients. Recently adopted in the Food and Drug Administration Safety and Innovation Act (FDASIA), the new definition of cGMPs clarifies this responsibility by including requirements for the pharmaceutical drug product manufacturer to demonstrate oversight and controls to ensure quality and establish the safety of materials used in the manufacture of drugs and finished products.

NSF International is working closely with IPEC and the FDA on the development of an American National Standard for excipient GMPs (NSF/IPEC 363: Good Manufacturing Practices for Pharmaceutical Excipients), based on IPEC’s Guide. NSF International is in the process of finalising this standard that defines GMPs for excipient manufacture for use in drug products and specifies the components of a quality management system for excipient manufacture and the GMP principles in IPEC’s PQG-GMP Guide for Pharmaceutical Excipients.

NSF International, Health Sciences Division, +1 734 545 3376, excipients@nsf.org, www.nsf.org/business/health_sciences.