NSF publishes first US standard for pharmaceutical excipients
The standard comes as the US FDA now requires pharma manufacturers to verify and document that raw materials used in finished products are meeting appropriate GMPs. Included in the NSF/IPEC/ANSI 363 standard for excipient GMPs is a new set of criteria for the quality management systems used in the manufacture of excipients.
Maxine Fritz, EVP of Pharma Biotech at NSF Health Sciences, told In-Pharmatechnologist.com: “The proactive application of this standard by the pharmaceutical industry would be twofold. Firstly, requiring suppliers to be certified to NSF/IPEC/ANSI 363 standard would mitigate considerable risk from the excipient supply chain for pharma companies and complement their own rigorous quality manufacturing systems…Also, this standard was developed in a consensus-based process with balanced input from regulators, excipient and pharmaceutical industry experts. As a result, the standard reflects the latest and best collective knowledge of excipient Good Manufacturing Practices. Further, as new technologies arise and best practices evolve, there is now an accredited consensus framework in place for continual improvement of the standard.”
Developed in partnership with the International Pharmaceutical Excipients Council (IPEC) and a committee of pharmaceutical excipient experts from regulatory, industry and academia, the standard references 14 regulatory guidelines and industry standards for excipients, including US FDA regulations, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.
Fritz told us that the goal moving forward is to have pharmaceutical companies require excipient makers to meet this standard. “Excipient manufacturers certified to the NSF/IPEC/ANSI 363 standard demonstrate to buyers that their excipients are manufactured to the appropriate GMPs for pharmaceutical use, which in most cases results in fewer customer audits. Both regulators and industry benefit from the time and cost savings.”
As far as what will change moving forward, Fritz added that, “In particular, there is greater weight placed on the role and commitment of management as well as building risk management practices into routine manufacturing operations.”
Pharmaceutical companies purchasing excipients certified to the NSF/IPEC/ANSI 363 standard are provided additional assurance of excipient quality and can elect to purchase audit reports.
“Implementation of NSF/IPEC/ANSI 363 is very feasible,” she noted. “The difficulty with any new standard is that some excipient manufacturers will be in better shape for meeting the requirements than others. This standard certainly raises the quality bar for excipient manufacturing and those companies that are proactive about pursuing certification have the potential to realize significant market advantage.”
The dynamics of the excipients sector will be discussed at our upcoming event “Excipient Innovations.” Register for the free to attend online event here.
