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The Global Technical Customer Support (TCS) team has as its main focus engagement with customers – facilitating access to West’s expertise in pharmaceutical packaging components and delivery solutions, and providing assistance and technical information on West and Daikyo products and services.
A major element of this is TCS subject matter experts partnering with customers throughout the process of selecting packaging components. This TCS partnership is accomplished by:
Furthermore, TCS is active in the pharmaceutical industry in many regards – participation in industry groups, attending conferences and exhibitions, and delivering papers and presentations. This enables TCS to be constantly aware of the latest trends, to best support customers. Strong relationships, exceptional service, and knowledge of the industry ensure that TCS remains the scientific destination for its customers. For more information on how TCS can provide support, or to request a product recommendation, complete our product recommendation form.
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.
Where is the product catalog? What is my item number? These questions are often asked by customers new to working with West. The problem with such questions when it comes to choosing primary drug packaging is both complex and simple: <em>people don’t choose the container closure system – rather, the choice is made by the properties of the drug product. In other words, the drug <span> </span>chooses the container.</em>
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.
The FDA states: <em>Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* </em>While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
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.
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