A survey conducted by the International Society of Pharmaceutical Engineering (ISPE) including both large and small pharma firms in the UK and Ireland indicates that while the cost and quality benefits of using quality by design (QbD) in development and manufacturing are beginning to be realized, the filing requirements for a QbD application are unclear.
The survey contained eleven questions that were focused on actual experience by the survey participants with QbD and the impact that its use has had on financial, quality, regulatory and staffing metrics.
At the ISPE Annual Meeting in early November in Dallas, Texas, industry consultant and former AstraZeneca official Bruce Davis provided a “snapshot” of the survey output. Davis was part of the ISPE community of practice (CoP) group that created and conducted the survey.
Survey results were divided to show the differing experiences with QbD by large vs. smaller companies. The big pharma participants told “a fairly consistent story” pointing to inventory reductions, better relationships between manufacturing and development, and more integrated business processes, Davis commented. Smaller firms – those with less than 500 employees – touted reduced batch failures.
He stressed there was a “universal ‘yes’ from all firms in response to a question asking if benefits had been realized in terms of product and process understanding.
Regarding staffing, the survey result from one of the smaller firms indicated that the use of QbD did not require additional resources. The firm commented that “we believe a more appropriate view is that quality by design is a transfer of resources from a downstream corrective mode to an upstream proactive mode.”
While some firms noted that they have seen reduced approval times, others said a QbD submission “requires a huge amount of data to be communicated to regulators and there is a lack of clarity in some requirements for what is actually needed when it comes to submission,” Davis pointed out.
ISPE plans to publish the full survey results and communicate them in a webinar format in the not-too-distant future, Davis said.[/membership]