Excipient resellers (distributors and other non-manufacturing suppliers) are key and often essential players not only in providing excipients to the various developers and manufacturers of drug products, but also in improving security of the overall supply chain for drug products. Many excipient AND drug product manufacturers are both confused and confounded by the complexity of the excipient distributor / reseller world. This webinar is designed to facilitate the who, what, where, how and why of excipient resale, including a discussion of the application of the NSF/IPEC/ANSI 363-2014 Excipient GMPs to distributors of various types.
- Name some excipient supply chain "events" and why product quality for excipients is important
- Recognize and distinguish between the various types of excipient suppliers, and what standards they should demonstrate adherence to based upon their scope
- Recognize and name the various Good Manufacturing Practices documents currently available for excipients and their corresponding relationships to excipient Good Distribution Practices
- Given the NSF/IPEC/ANSI 363-2014 Excipient GMP standard, discern which requirements apply to the various distributor types
- Understand and list steps to help assess excipient distribution supply chain steps and integrity whether you are a supplier or user
Linda joined IPEC-Americas in 2015 as a training, technical and membership operations specialist. She is a key part of the IPEC-Americas Learning Laboratory Staff and Team, helping to provide valuable excipient training and education for excipient makers, users, distributors, regulators, and other stakeholders.
In her over 20 year career overseeing Quality in manufacturing and distribution of food and pharmaceutical products, Pam has focused on implementing highly conservative product safety systems and coaching for those adopting and continually improving to key standards.
Since joining Univar in 2013, Pam Malcontento has been focused on creating strong quality systems and a quality culture to differentiate Univar as a key partner to their Pharmaceutical as well as all other industry customers.