Stoppers

When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure. For the purposes of this discussion, the focus will be on the functional performance of the stopper and what key aspects should be considered during the assessment and selection process. Coring and fragmentation, container closure integrity, and machinability of the stoppers will be briefly reviewed.

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and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)” (15 October 2019).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.