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To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)” (15 October 2019). This indicates that the evaluation of the consistency of injections has finally begun. This Exposure Draft clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.
As one of the most critical factors in the evaluation of drug packaging, Container Closure Integrity (CCI) is mentioned in these new technical requirements:
These new components were developed based upon West’s extensive knowledge and experience in drug packaging systems. Anticipating publication of the Exposure Draft, West evaluated CCI of AccelTRA stoppers with various ISO-compliant vials, using the USP 1207 endorsed methods – tracer gas and headspace analysis (Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods. PDA Journal of Pharmaceutical Science and Technology, 74 (1), 147-161 (2020)(https://journal.pda.org/content/74/1/147). Excellent performance was demonstrated.AccelTRA components facilitate risk mitigation and enable reduction in testing, which can help getting to market faster.
To learn more visit our AccelTRA component program page or contact an Account Manager or Technical Customer Support (TCS) representative.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Recently, the generics pharmaceutical industry in the United States has seen the average time to market decrease significantly as approvals have steadily increased thanks to the introduction of the Generic Drug User Fee Amendments (GDUFA) in October 2012. The reduction in time has led pharmaceutical companies to seek out high-quality elastomer products that provide the regulatory simplicity necessary to bring their products to market quickly, helping to increase a company’s competitiveness and their drug product’s overall sales. The AccelTRA™ elastomer program is built on these features: Quality, Speed, Simplicity.<br />
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, <em>Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft)</em> 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.<br />
West is pleased to announce that the AccelTRA™ component program has been recognized with a 2018 India Packaging Award in the category of “Packaging Design in Injectables.” The award was announced during a ceremony at the 2018 InnoPack Pharma Confex in Mumbai, India on May 24, 2018.
West’s Integrated Solutions program brings together all West’s products/services and industry knowledge into customer-focused solutions that Simplify the Journey™. One aspect of Integrated Solutions is wide-ranging analytical services, which includes state-of-the-art container closure integrity (CCI) capabilities. Understanding CCI as it relates to industry expectations, manufacturing, and regulations can be a challenge.
For any drug, selection of the appropriate primary packaging components is essential to having a containment system that ensures quality, safety, and stability. The primary packaging components are selected based on various factors, which include chemical compatibility with the drug product ingredients and dimensional fit with mating packaging components. Optimized fit among mating packaging components is essential for flawless fill-finish processing.
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