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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 guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections” (21 October 2020), which indicates the beginning of injection consistency evaluation. This guidance 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.
Container Closure Integrity (CCI) is one of the key factors for the quality and safety of the entire product lifecycle of pharmaceuticals. To better address this topic, NMPA issued “Technical Guide for Research on Package Integrity of Chemical Injections (Trial)” on 21 October 2020. And 4 years later, “9650 Guidelines for Research on Pharmaceutical Package Integrity” is published as Chinese Pharmacopoeia (ChP) 2025 chapter on 19 Feb 2024. This new publicity helps to guide the implementation of CCI of pharmaceutical packaging materials and provides effective ways to comprehensively assure the quality of drugs.
One of the references of ChP <9650> is USP <1207>. Both chapters mention the below requirements on CCI:
With 100 years of elastomeric closure manufacturing experience, West also has extensive knowledge of the associated regulations affecting pharmaceutical drug manufacturers. Anticipating publication of this ChP chapter, West evaluated CCI of stoppers in elastomer 4031/45 Gray with various ISO-compliant vials. USP<1207> endorsed methods were used – 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).
Stoppers in elastomer 4031/45 Gray within the AccelTRA® offer deliver packaging quality, speed, and simplicity to affordable medicine manufacturers. These stoppers should be the first choice for affordable medicine manufacturers because:
These stoppers were developed based upon West’s extensive knowledge and experience in drug packaging systems. Stoppers within the AccelTRA offer facilitate risk mitigation and enable reduction in testing, which can help get your product to market faster.
To learn more, visit The AccelTRA Offer 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.
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.
Selection of the appropriate primary packaging system is essential to delivering a high quality, safe, and stable drug product to patients. The primary packaging components which make up the containment system are selected on a range of factors, from chemical compatibility with the drug product ingredients to dimensional fit when mating packaging components. Optimized fit among mating packaging components is essential for flawless fill-finish processing.
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 />
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.
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.
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