Change Management of Elastomeric Packaging Components in China
Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
Per Dossier Requirements for Pharmaceutical Packaging Materials (Interim), announced by China Federal Drug Administration (CFDA) (CFDA Announcement 2016 #155), a related guideline will be published for pharmaceutical companies’ reference when they encounter any change notifications from materials suppliers. Earlier this year during the Pharmaceutical Packaging Regulation and Technical Open Symposium in China, which was co-organized by West’s Global Scientific Affairs team and CNPPA (China National Pharmaceutical Packaging Association), Fran DeGrazio, Vice President of Scientific Affairs and Technical Services, presented the West change control strategy. The presentation explained the strategy's importance in assuring product quality and consistency, and covered the following points:
- Each component formulation is developed to achieve certain chemical and physical properties to meet the end-use purpose and application. The final critical product attributes of the formulation result from the raw materials and relative quantities.
- The West control strategy covers raw materials through manufacturing process to final products.
- West uses a variety of criteria to address changes based on USP 1195 guidance.
- Ash value was used as an illustration wherein the specification is established when the formulation is developed – upper and lower limits take into consideration production capability and controls.
Proper change control procedures, coupled with a robust control strategy, are necessary to assure adequate packaging component quality. Tests and specifications should be based on scientific understanding of formulation and product requirements. Fran’s presentation demonstrated that the West change control strategy is based on robust scientific understanding of elastomeric packaging components.