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New Standards for Excipient GMPs: Analyzing the Impact of NSF/IPEC/ANSI 363-2014
Most drugs contain 70-90% excipients, which serve as taste-maskers, glidants, anti-oxidants, flow aids, binding agents or other purposes that facilitate the manufacturing process and improve chemical stability. The globalization of the pharma industry, combined with a regulatory focus on preventing counterfeits and adulterated products has created a need for a comprehensive excipient quality and control standard.
Now NSF International, the American National Standards Institute, and the International Pharmaceutical Excipients Council of the Americas have released the final version of NSF/IPEC/ANSI 363-2014, the first American National Standard for good manufacturing practices of pharmaceutical excipients.
Currently voluntary, the FDA was deeply involved in its development, and ANSI and NSF are trying to persuade the FDA to adopt it as official guidance or regulation.
The standard covers everything from cross-contamination to change control, recordkeeping and equipment maintenance. It advises conducting risk assessments in order to determine the need for risk mitigation strategies. Such an assessment by the quality unit should identify materials and services that could affect excipient quality and track that status from delivery to customers.
Excipient makers must also establish a process for tracing excipients to the finished drug maker. Furthermore, they need to have a documented system for selecting, approving and reapproving their suppliers, as well as defining how they will assess changes and alert clients, and creating procedures to handle customer complaints.
No matter where you are in the supply chain, the new excipient standard is crucial knowledge to make sure quality controls prevent your product from being at risk.
In this one-of-a-kind 90-minute presentation, you will learn:
This course will be of benefit:
James Morris — Executive Director, NSF Health Sciences
Jim has significant experience in plant operations and has spent over 25 years in the industry with Pfizer as well as Cilag AG and MassBiologics in the US and Europe. He has held positions as Deputy Director QA/QC and Regulatory Affairs at Mass Biologics in Boston, Director of QA/QC for the Biologics business unit of Cilag AG in Switzerland, and a number of Quality Assurance and Manufacturing roles with Pfizer, Inc. over a 16 year timeframe culminating as the head of Quality Assurance for Pfizer in Latina, Italy. Areas of focus include Aseptic Operations, Quality Management Systems, specifically in the areas of deviations / CAPA management and change control. Jim’s course and speaking engagements are in the areas of Human Error Reduction, Quality Management Systems, and Emerging Markets. Jim has been working in a consulting capacity since 2008.
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