This members only document serve as a reference document on the impact of Annex 1 on CCI for existing and new workstream members and is a collation of responses surveyed, narrative and notes made during discussions between SMEs and where applicable guest speakers.
container closure integrity
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The scope of this paper focuses on CCIT of viral vector gene therapy drug product (DP). Cell therapies are out of scope. The strategy proposed here for CCIT is applicable to all advanced therapy medicinal product (ATMP) drug products that are manufactured in small lot sizes, typically <500 vials.
Container Closure Integrity: User requirements specification (URS) for optimized container closure integrity testing equipment
The paper highlights a long-term desired view of CCIT to help develop equipment that can better meet end-user requirements. It will also provide confidence that CCIT methods can effectively demonstrate container integrity, such as microbial, headspace (gas, vacuum and moisture) and product integrity. It provides a long-term goal for companies that often use multiple CCIT technologies, with varied capabilities, to support the requirements of an expanding product portfolio. The URS will help overcome the significant inefficiencies that companies face. It will also help resolve the problem that the range of deterministic CCIT methods currently available do not represent a panacea for CCIT.