Performance of AccelTRA® Components
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and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)” (15 October 2019).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:
- CCI should be validated with proper methodologies in the process validation;
- CCI can replace sterility testing at other time points excluding the beginning and final stages during stability study – physical testing methods are encouraged to be applied with methodology validation West has launched the AccelTRA® 4031/45 component program to deliver packaging quality, speed, and simplicity to generics customers.
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.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.