Trends, challenges and priorities
To address these challenges, drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations are working relentlessly to continually improve the pharmaceutical quality system (PQS). BioPhorum Fill Finish has recently made progress in best practices in several key areas: sterile filtration quality risk management (SFQRM), environmental monitoring (EM), container closure integrity (CCI), visual inspection (VI) and isolator gloves management. The seminal work of the SFQRM consortium which provides a risk-based approach to the sterilization of filters has been very well-received by industry and health agencies.
In these areas, major improvements with currently available technologies are also being evaluated and the barriers to adoption being cleared. For example, the Alternative and Rapid Micro Methods (ARMM) team is working to remove settle plates in grade A areas with direct-detection systems (i.e. bio-fluorescent particle counters (BFPCs) that can detect viable and non-viable particles in real-time). The Isolator of the Future team is developing best practices for automation that will reduce the need for human beings, which is the primary contamination risk. In 2021, the Phorum’s Container Closure Integrity (CCI) team provided a user requirement specification for testing technologies. However, industry must recognize that the future is not just about implementing new technologies but introducing them in a ‘smart’ way.
The Phorum’s ethos is very much about declaring success when best practices are implemented. All workstreams are missioned to both deliver best practices and provide stewardship and support for wide-scale implementation.
An essential element to successfully meet challenges is the need for a single industry voice. The Phorum will utilize BioPhorum’s collaboration with the USP and continues to form partnerships to add value for members, which include: the SFQRM consortium with the Parenteral Drug Association (PDA); the ARMM team’s partnership with thought leaders in the PEMM group and OWBA; and discussions with EDQM’s Expert Group 1 EDQM; the EM team and the team revising the PDA’s TR13; and the Phorum’s Robotic team coordination with the ISPE–DACH’s Robotics Special Interest Group. The Secondary Packaging team are also working with experts from GS1 on ePI (electronic patient information). The Lyophilization team in October 2021 partnered with the University of Purdue’s Advanced Lyophilization Technology Hub to work on a paper on technology transfer best practices with case studies.
At the beginning of 2021 a set of manufacturing scenarios were defined by our members, that are required to address the opportunities and challenges mentioned above. The emerging goals are shown in the figure below. In the final months of 2021, we are developing a plan to work collaboratively towards a future set of priorities. Including an ambitious consortium project to accelerate progress towards commercial lines of the future. The Phorum members also want to create space to support each other with the implementation of Annex 1, a key driver for changes to filling operations.
Many of the Phorum members depend greatly for fill finish capacity on contract manufacturing companies. While several contract manufacturers are valued members of the Phorum, we continue to encourage our members to collaborate and keep pace with licence holder’s views on best practices; in turn contract manufacturers could connect with their client to eliminate variation in practices which add no value
Fill Finish deliverables 2020 – 2021
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