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The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).
Second Draft … was revised based on comments received on the first draft, which was published in February 2018. Both drafts note that the purpose of a stability study is to investigate the performance of primary plastic and rubber packaging materials with time , under defined temperature and humidity conditions. The study will provide a scientific basis for manufacturers of packaging materials to identify and recommend storage conditions and effective shelf life. The shelf life of the packaging materials from the pharmaceutical manufacturer’s perspective should start from the manufacture date of the packaging material, to the end of the drug product shelf life.
Key points of Second Draft … include:
Comments are being collected for Second Draft … – the timeline for official release is not known yet. The West Scientific Affairs team will remain vigilant on this, and other regulatory matters, in order to help customers effectively navigate the regulatory landscape.
<p><em>Part 2 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director,</em><em> Xavier University. This is the second installment in a four-part series on supply chain management.</em></p><p>In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).</p>
With the prevalence of Non-alcoholic Steatohepatitis (NASH) rapidly increasing globally, West is working with its pharmaceutical partners to support their development of new injectable treatments for this serious liver condition. However, there are many challenges associated with trying to bring new treatments to market.<br />
Diane Paskiet, Director, Scientific Affairs, serves as co-chair for the 2014 PDA Packaging Conference: Pharmaceutical Packaging Systems – <em>Current and Emerging Practices, Technologies and Materials</em>, which will be held at the Washington Marriott Wardman Park, Washington, D.C. on May 20-21, 2014.
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
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