In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
News|Videos|June 26, 2024
Quality Considerations in Changing Excipient Providers
Author(s)Felicity Thomas, Susan Haigney
In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.
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Changing excipient providers is not as simple as it may seem. The surge of complex therapeutics makes it even more complicated, according to Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. “I would go visit them and look at their culture and what they're doing in the way of change control and how their QMS is handled, because that is going to be critical to securing your supply chain with this new excipient provider,” Schniepp says.
According to Siegfried Schmitt, vice president, Technical at Parexel, excipient providers are inspected by regulators and require audits to be performed by the company purchasing the ingredients. “And there are various ways of performing an audit. Of course, it doesn't always have to be on site, in person. It can also be, for example, [a] questionnaire [sent to the supplier], and you hope you get something filled in truthfully. You can perform online searches. Many excipient providers have very good reputations and standings in industry, and some also provide audit reports or certifications from independent companies like EXCiPACT,” Schmitt adds.
Click the video above to watch Sue and Siegfried answer the question: “My company is looking at changing our excipient provider for our therapeutic pipeline, what quality issues should we consider when choosing the grade of our excipients and what should we ask of our new provider?”
Important terms and acronyms
DMFs – drug master files
GMP – good manufacturing practice
QMS – quality management system
Ask the Expert video series
Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. We hope you enjoy the discussion!
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