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West was pleased to recently attend the U.S. FDA’s first Compounding Center of Excellence Conference “Working Together for Patient Safety” on September 21st and 22nd. The virtual conference brought together current and future outsourcing facilities, state and federal regulators, experts, trade organizations and other industry stakeholders to learn and engage on key topics and best practices.
The general conference themes were shared responsibility for quality, promoting compliance and open communication and collaboration. Over the course of two full days, there were sessions on regulatory guidance, CGMP foundations, active pharmaceutical ingredient sourcing and bulk drug substances, inspections and responding to Form 483s, as well as updates on compounding during the COVID-19 pandemic. The industry has played a key role in assuring supply of needed medications to hard pressed hospitals, especially during the quarantine.
One of the most interesting sessions presented a case for automation and technology investment by STAQ Pharma, a brand new 503B outsourcing facility. The company representative not only shared the content of their business case, user requirement specifications and the process by which they evaluated automation options but also a video of the equipment in action. This included robotic vial filling.
West was interested to hear about upcoming Center of Excellence activities including additional training, research and analysis and regulatory science, as well as further engagement with the compounding community. We welcome the opportunity for West’s world class laboratory to assist in obtaining meaningful scientific evidence that supports regulatory decision making and provides informed guidance to outsourcers facing quality issues. We look forward to further interaction with FDA as well as our compounding pharmacy customers at next year’s conference.
West will be exhibiting and presenting at the Informa Connect Compounding Pharmacy Compliance conference.
On August 6 and 7, 2019, USP hosted the Second Annual Workshop to explore current trends, initiatives and regulations for quality compounding. Members of the West Pharmaceutical Services, Inc. (West) Scientific Affairs and Strategic Marketing departments participated in the USP workshop and gained valuable insight into the key elements of the FDA’s efforts to improve the quality of compounded drugs.
The pharmaceutical supply chain is more complex than ever, with the pricing of critical drugs a subject for hot debate in the media and, most recently, in U.S. Congressional hearings.
Automation is quickly becoming a major part of the world in which we live. From consumer applications like microwaves and automobiles, to use in large-scale factories that produce everything from dollar-store hair accessories to autopilot-driven aircrafts, automation surrounds us. This is a good thing – the products we use benefit from the increased quality, consistency, and productivity provided by automated systems.
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
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