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West is committed to delivering safe and efficient drug packaging products to our customers. Part of that commitment involves keeping the industry abreast of the latest regulatory and technology developments/challenges in packaging and delivery. West recently hosted, at its Exton headquarters, an installment of the ongoing Educational Series, titled: Managing Risk in Injectable Drug Delivery: Regulatory and Technical Challenges and Solutions.
Topics and speakers included:
More than 30 scientists and engineers from pharmaceutical companies learned about the latest changes in regulations, as well as the challenges in managing particles, container closure integrity, extractables and leachables, and device performance. The presentations included case studies of how critical analyses of these areas enabled control of risk, as well as successful drug product packaging and delivery.
Attendees also took a tour of West’s Analytical Laboratory Services facilities. West's scientific experts and excellent experimental capabilities can help customers understand regulatory and technical issues, and design and execute studies to address them.
Visit the West Knowledge Center to gain insight on industry trends and guidance. If interested in the next Educational Series or how West can support you – contact a Technical Customer Support representative.
Ensuring the safe containment of sensitive drug formulations requires a thorough evaluation of the container closure system. Selecting the packaging components requires knowledge about not only the drug formulation's requirements, but also the components’ material properties. Chemical compatibility of components with the drug formulation is key. Proper selection of components will provide the right closure design, assist with handling and help ensure container closure integrity throughout a drug product’s shelf life. Managing these factors well is critical, and West can help.
Since the Technical Guideline on Compatibility Study of Chemicals and Elastomeric Closures was published by the National Medical Products Administration (NMPA, previously known as CFDA) in April 2018, it is essential for pharmaceutical companies to perform compatibility studies. However, for some domestic pharmaceutical companies that lack experience, it is unclear how to perform such a study. To address this, a series of trainings was planned by China National Pharmaceutical Packaging Association (CNPPA) – with the first held in December 2018. There were over 100 attendees from pharmaceutical companies, pharmaceutical packaging companies, NMPA-affiliated labs, and the third-party labs. The training received positive feedback from the participants.
Extractables and leachables (E&L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&L, which has led the <em>Center for Drug Evaluation</em> under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): <em>Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures.</em> The compatibility study discussed therein focused on E&L.
At West, our focus is on supporting the biopharmaceutical industry in qualification and commercialization of containment and delivery systems for injectable medicines. <span></span>Selecting high-quality drug packaging that meets regulatory standards is essential to a drug manufacturer’s success. <span></span>West’s top priority is delivering high-quality packaging products that meet the exacting quality standards and product specifications customers require.
Earlier this year, we held a free 3-day virtual workshop (4 hours per day) bringing together industry experts and thought leaders in a unique forum to address a series of challenges and practical strategies to de-risk their injectable combination product development and commercialization.
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