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In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft) by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.
Container closure integrity (CCI) is critical for all pharmaceutical packages, and it has been mentioned several times in new published technical requirements, which recommend that proper methodologies should be applied in CCI testing. Packaging is becoming more complex, and more CCI test methods have been developed; however, it must be emphasized that there is no one method that works for all applications. In China, as elsewhere, many pharmaceutical companies do not yet have a full picture of CCI testing. Recent USP<1207> Packaging Integrity Evaluation-Sterile Products gives an overview; detailed information can be found in three sub-chapters: USP<1207.1> Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation, USP<1207.2>Package Integrity Leak Test Technologies, and USP<1207.3> Package Seal Quality Test Technologies. The guidance encourages the use of deterministic methods instead of probabilistic methods, for the former is much more reproducible and sensitive. A shelf-life CCI assessment is also recommended to ensure maintenance of drug quality.
West has extensive experience in CCI testing by several methods – vacuum decay, helium leak, high voltage leak detection (HVLD), and laser-based headspace analysis through Analytical Laboratory Services. Contact your Account Manager or Technical Customer Support (TCS) representative for more.
West’s team members in Germany have spent the past month on charitable activities as part of the 2013 West without Borders fundraising initiative. Donations inspired volunteers to prepare lunch, snacks and desserts for their colleagues. Other activities included a raffle, various food sales and a flea market at plants in Eschweiler, Stolberg and the European Headquarters at Kiefernweg to help raise money for local children in need. This year’s motto was “Gemeinsam erfüllen wir Herzenswünsche” (Together we make dreams come true).
According to Health Resources & Services Administration (HRSA), in the US about 110,000 people are waiting for organs right now and about 20 patients die each day waiting for a transplant<sup>1</sup>. Due to shortage of donors and requirements for matching, there is a huge demand for manufactured tissues and organs. Bioprinting has emerged as a very promising tool for solving this major unmet need in healthcare.
As the pharmaceutical industry evolves amidst changing patient needs, growing regulatory requirements and improved process understanding, West is moving forward with product improvements of its own. In addition to our continuous process and product improvements and optimizations, West is harmonizing its steam sterilizable ready-to-use (RU) product packaging material.
The PDA Annual Meeting, “Modern Sterile Product Manufacture – Exploring Best Practices and Seeking New Approaches,” will be held April 15-17, 2013, at the Peabody Orlando in Orlando, Florida. This meeting will focus on the challenges currently faced by the pharmaceutical industry, advances in modern manufacturing and look ahead to the future of the industry.
<span>Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product. Recently, PDA presented an <a href="https://www.youtube.com/watch?v=mol_X2zQeig">interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs</a>, discussing FDA’s approach to evaluating E&L information </span>
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