Changing landscape of injectable packaging regulations

Dynamic changes in packaging regulations signify a crucial evolution, demanding industry adaptation for enhanced safety and compliance. Therefore, Prabhaharan Sankaran, Sr Technical Account Specialist, India, West Pharmaceutical Services India elaborated on how the evolving regulations affect the injectables packaging landscape.

Revised USP <660> chapter made official on October 01, 2023. Valor Glass Vials by West Pharma meet global pharmacopeia standards. Glass passing the test for Type I can be used for drugs that require Type I glass. Its technical advantages include the elimination of glass contamination, exhibiting a low and consistent extractables profile, resisting damage and increasing throughout on filling lines.

Other regulatory lookouts include the new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025.

Sankaran also highlighted how a Notified Body Opinion will need to be included within the Marketing Authorisation Application becoming a critical part of the approval pathway as per EU MDR.

Additionally, the revised EU GMP Annex 1 has been effective since August 25, 2023, which requires a more stringent contamination control strategy and the recommendation for use of RABS and Isolators.

The regulatory requirements need to keep up with the latest global trends and technology to further ensure patient safety. Therefore, it is in the best interest of the pharma packaging stakeholders to stay abreast and monitor major developments.