The US regulator mooted the idea quality metrics reporting in 2015, arguing the data would help it target inspection resources and more accurately predict shortages. The agency also said it would encourage manufacturers to adopt robust quality management systems.
The original plan – which proposed asking manufacturers for 10 metrics – raised industry concerns. PhRMA asked the Food and Drug Administration (FDA) for more details as did IPEC Americas, while the International Society for Pharmaceutical Engineering (ISPE) called for a phased introduction.
The latest version of the draft guidelines – published in November 2016 – introduced a voluntary reporting phase and cut the number of metrics companies would be asked to report to three: lot acceptance rate; invalidated or out-of-spec rate; and production quality complaint rate.
The revisions are an improvement but more work is needed according to trade and technical organizations which wrote to the US FDA late last month.
The group – which includes PhRMA, AAM, ISPE, the Pharma & Biopharma Outsourcing Association, APIC and SOCMA’s Bulk Pharmaceutical Task Force – said the plan should be “paused” to allow the benefit, or otherwise, of collecting such information to be assessed.
“We believe that the burden of FDA metrics collection far outweighs the benefits, at least as currently proposed” it said, adding that collecting such data would “require substantial resources, present significant operational challenges and complexities, and draw resources and management attention away from other programs that drive continual quality improvement.”
IPEC Americas – which represents excipient manufacturers – also voiced concerns, arguing that the quality metrics proposed by the FDA would be hard to apply to excipients “because manufacturing processes are different.”
The organisation said “since the draft Guidance still has many unanswered questions for the finished drug product manufacturer, it is IPEC-Americas position that the Guidance should be devoted to pharmaceutical drug products and not expanded to include excipients and atypical actives.”
The US FDA has not set an implementation deadline for the revised guidelines, but did say an electronic submission platform for such data will be up and running for testing purposes sometime this year.