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With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug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).1 The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
Compounding pharmacies need to understand that overall drug stability, safety and efficacy are contingent on the sterility of packaging, i.e., container closure systems, and downstream activities such as aseptic fill/finish rely on that packaging sterility. Historically, compounding pharmacies have purchased Ready-to-Sterilize (RS) packaging and performed sterilization at their own facilities to keep costs low. Now, if compounding pharmacies do not use pre-sterilized single-use containers and closures, the FDA guidance requires more rigorous quality assurance activities, including validation of sterilization processes and documentation demonstrating consistently effective sterilization before first use. The FDA guidance increases the operational cost and complexity of sterilization processes by requiring proof of validation and increasing documentation necessary to establish the suitability of the 503B as a sterilization facility.
To continue to meet the sterility requirements of current good manufacturing practice (cGMP), compounding pharmacies have two options: 1) undergo increasing scrutiny of their sterilization processes; or 2) purchase Ready-to-Use (RU) packaging. Previously, the lower price of RS packaging may have outweighed the benefits of RU packaging. Now, the tables have turned, and RU packaging may prove the better return on investment for the simple reason that 503Bs can pass the burden of demonstrating packaging sterility to their supplier.
Westar® Ready-to-Use (RU) components can streamline production and eliminate many sterilization processes related to component preparation. Benefits of Westar RU packaging include:
West ensures sterility of packaging systems by offering:
West is committed to the safe and efficient delivery of drug products. An element of this commitment is staying abreast of regulations and offering customers the information and testing services they need through the Integrated Solutions platform. For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
West is proud to announce that Diane Paskiet, Director, Scientific Affairs will serve as Co-chair at the upcoming PDA Packaging Conference in Baltimore, MD. In her leadership role for the meeting, Diane will moderate several sessions, including <em>Repackaging – Problems and Solutions</em> and <em>The Future Direction of Devices and Patient Adherence/Compliance</em>.
Diane Paskiet, Director, Scientific Affairs, will present at two sessions during the <strong>2012 PDA Annual Meeting. The meeting will be held from April 16-18, 2012 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.</strong>
On October 20, West and President & CEO, Eric M. Green, were recognized as a Health Care Innovator by the <em>Philadelphia Business Journal</em>.
We recently sat down with Dr. Bettine Boltres, our contact for scientific affairs and technical solutions for glass. In her role she is supporting pharmaceutical companies to address glass-related topics from a scientific perspective and to gain a deeper understanding of the material that holds their valuable drug products. Having done this for many years, we wanted to know what the most frequently asked questions are that she encounters. Please read Part 1 of our two-part series around the 10 most commonly asked questions around glass vials:
West has created a technical resource site to provide its customers with specific product information that is available whenever our customers want it – 24 hours a day, 7 days a week!