FDA’s revised quality metrics plan praised for offering greater flexibility

Regulatory NewsRegulatory News | 28 March 2022 |  By 

The US Food and Drug Administration’s (FDA) revised quality metrics plan is an improvement over previous iterations as it offers more flexibility to drugmakers by giving them options on what type of metrics data to submit, according to stakeholders who spoke to Focus.
FDA also showed responsiveness to industry concerns by asking how metrics data should be submitted, either by site or by product, according to a consultant and a consumer industry group, who were asked by Regulatory Focus to share their early thoughts on the revised plan. The deadline for submitting comments on the program is 7 June. (RELATED: Quality metrics: FDA wants feedback on pared-down program, Regulatory Focus 8 March 2022)
Yet the emerging program could benefit from more active collaboration between industry and the agency outside the formal notice and comment process, asserted Steve Greer, a quality consultant recently retired from Proctor & Gamble, who has been actively involved as an industry partner helping FDA shape its quality metrics program.
Another industry official acknowledged the ongoing difficulties in coming up with standardized definitions for metrics acceptable to all segments of the pharmaceutical industry.
Agency has learned from pilots
Greer said the proposal is a step in the right direction and that the agency listened to industry’s comments on how metrics should be collected through its voluntary quality metrics program and quality metrics feedback program launched in 2018. (RELATED: Quality metrics for pharmaceuticals: FDA unveils two voluntary programs, Regulatory Focus 28 June 2018)
In its latest plan, FDA requested comment on whether quality metrics data should be reported by establishments. In doing so, the agency was responding to industry feedback that metrics should be collected by sites only and not by products.
In the initial program, FDA proposed quality metrics reports be segmented by products and for these metrics to be compared from site to site, not within sites.
“I do appreciate the fact that FDA has heard and played back to us some of the key messages we tried to communicate during the site visit program as well as the feedback program,” said Greer.
“I think that was a big step forward in terms of building in flexibility and just having a site look at itself rather than compare. I think that was really the main thrust of this docket …. This speaks to the fact that industry for the most part said they would prefer to report data on a site level rather than a product level.”
Greer added that, “Breaking things down to a product [level] is very labor intensive and often you don’t get a clear picture of how a site is performing.”
CHPA supports four quality practices areas
The Consumer Products Healthcare Association (CHPA) also voiced support for the proposal for its flexibility in allowing manufacturers to select metrics from four practice areas to report to the agency. The four general practice areas are manufacturing process performance, pharmaceutical quality system effectiveness, laboratory performance and supply chain performance. Each practice area contains multiple quality metrics manufacturers can select to report on.
CHPA said in a written statement to Focus that it “welcomes FDA’s refined quality metrics reporting program which focuses on four critical practice areas related to product quality and availability allowing flexibility for manufacturers to select metrics which are meaningful to their specific products.”
CHPA is working with members to submit additional comments.
Greer calls for more collaboration with industry
Greer said that while FDA is on the right track in developing its quality metrics program, its development could benefit from more active stakeholder involvement.
“The part that I wish were different is the methodology that is being used to develop the program,” Greer said, noting the multiple rounds of notice and comment that have defined the process thus far. “This has taken a lot of time and a lot of conversation, and it has been done in a very structured way. I go off by myself and do some work and I throw it to you, and you analyze it and throw your comments back to me.”
He added that, “What I am asking them to do for several years now is to collaborate more actively in developing this program. I would like to see us lock ourselves in a hotel room for a week or two and develop a program together, where we could talk through the points, and we can analyze the program and then come up with a program collaboratively building it.”
Greer said this active collaborative approach is reflected in FDA’s Center for Devices and Radiological Health’s (CDRH) case for quality program, which launched in 2011 to advance medical device quality and safety.
“They had all of the key stakeholders together…. everything I have heard about it is that it is a very good program, and it is well structured and there are good incentives for the industry and is really driven by the objectives that CDRH had designed.”
This active collaboration is missing in the quality metrics work, Greer said.
Standardization is difficult
John DiLoreto, executive director of the Bulk Pharmaceutical Task Force (BPTF) acknowledged the complexities in devising a quality metrics program acceptable to all segments of the industry. His group is reading through the plan and has not yet drafted formal comments.
“Quality metrics is one of those things, in theory it sounds like a great idea but then in practice you start seeing difficulties because there is so little standardization across the number of products and substances that are being developed, and what metrics are being used in each of those processes? These may be different, and it is hard to find something that is standardized across products and processes. That is one of the reasons why [quality metrics] kind of languished a little bit.”
For example, he said that, “Terms such as ‘lot acceptance’ may be good for some [companies] but not for others.”
Under the proposed program, manufacturers would have submitted four primary metrics (lot acceptance rate (LAR), product quality complaint rate (PQCR), invalidated/overturned out-of-specification rate (IOOSR) and annual product review (APR) or product quality review on-time rate) and three optional metrics (senior management engagement, corrective and preventative action (CAPA) effectiveness and process capability/performance.
DiLoreto said these complexities surfaced when manufacturers were required to report manufacturing volume data under a provision in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
“Companies collect data and report it in different ways. It is not set up for any standard way or reporting, and FDA is not helpful in defining what a standard is. It is very easy to report the number of tablets that you manufacture, but where they end up may be a challenge …. On our side, in bulk manufacturing, if we manufacture 100 pounds of a substance and it goes off for distribution, we have no idea where the 100 pounds wind up.”
Drugmakers and active pharmaceutical ingredients (API) suppliers have said they need more time to comply with the CARES Act manufacturing volume reporting requirement. (RELATED: Industry seeks delay for reporting manufacturing volume data, Regulatory Focus 12 January 2022)


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