Malik Belattar, chair of the ISPE Disposables Steering Committee and Pharma Biot’Expert’s representative, invites you to join the discussion about several important topics related to disposables. The ISPE Communities of Practice (CoP) has highlighted critical issues to improve the overall awareness on best practices, technology and regulatory approaches to Single-Use technology in the industry and how to consolidate and align good practice guides with other ISPE communities’ efforts. The ISPE Disposables Steering Committee believes it is important to open discussions to the pharmaceutical community to raise up technical recommendations with respect to a consensual approach from both end-users and suppliers’ expectations. This year, the two main discussion points of the ISPE Disposables CoP are:
- Qualification of Single-Use technology components
- Are multiple qualifications required for different applications?
- Single-Use connections and tubing
- What standardization is really needed?
We want your input! Visit the ISPE Disposables CoP to comment. The next Committee meeting will be on 26 May 2016. Not a member of the ISPE Disposables CoP? Update your profile or join ISPE today! As part of the ISPE Good Practice Guide project that will be developed, taking into account input from the upcoming discussions, the Committee will develop articles and presentations that support these topics and several other topics covered by the guide, such as:
- Implementation of E&L studies based on a standardized risk assessment
- Determination of integrity testing methodology
- Scope and set up of a biocompatibility study
- Critical attributes of Supply Chain Management
- Implementation of a change control procedure for Single-Use components and assemblies
These topics will be reviewed throughout the ISPE CoPs and during the guide review. If you would like to participate in these workshop discussions, please comment in the blog post below.
