Since the CPV team published its seminal 100-page case study in 2014 (Continued Process Verification: An Industry Position Paper with Example Plan), they’ve been working hard to socialize and encourage a wide industry take-up of the practices.
The team has been working on a number of white papers covering some of the practical considerations of implementation. They divided these challenges into a series of subtopics, and team members have set about writing a range of papers tackling these more focused issues. For example, the initial case study work was more aligned to CPV as applied to new products and APIs. One of the subgroups is now looking at CPV with legacy products, and there are three other publications in preparation: A Roadmap to the Implementation of CPV; Responses to Signals and; the Validation of Informatics Systems for CPV.
The subtopic papers aren’t yet ready for publication yet, but team members are keen to socialize their messages ahead of appearing in print, and are looking to spark discussion to hone their ideas further.
A great opportunity to exploit their work and explore their ideas further came about in July at the CMC Summer Forum of the California Separation Science Society (CASSS) in Gaithersburg, MD, where CPV was the specific focus of the meeting. The CPV team took the decision to attend the CASSS forum en masse, to share their messages through specific examples, and to an audience that regularly includes a strong regulatory presence.
The team’s presence and messages were well received by industry and regulatory representatives. Copies of the CPV Case Study were taken away and delegates at the meeting expressed strong interest in the four papers the team has in draft. It is also becoming clear that the industry is developing consistent approaches to implementing CPV and that the BPOG team is playing a real part in this process. The team is picking up signals that educational materials might be welcomed by regulators and other members of the industry, and they are very willing to prepare resources as the pull strengthens.
In the longer term, the team is exploring data interface standards that will enable more efficient and effective aggregation of data from different source systems and advanced analytics. Advanced analytics are expected to link to automated process control and real-time batch release with the associated cost and time savings. This could be transformational for the industry and work has started on this aspirational goal, with representatives looking for benchmarking opportunities and seeking input from vendors and suppliers.
Continued Process Verification: An Industry Position Paper with Example Plan is available on BioPhorum’s website: Click Here to view