OPQ touts progress on quality management maturity, KASA in annual report

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) reported that progress has been made over the past year in advancing its quality management maturity initiative and in its quality assessment review process in its 2022 annual report.
 
The report also describes progress made in other areas under OPQ’s remit. The office’s previous two reports focused largely on its COVID-19 response. (RELATED: FDA’s OPQ reports on drug quality efforts in 2020, Regulatory Focus 11 February 2021; FDA’s OPQ 2021 report focuses on pandemic responses, Regulatory Focus 23 February 2022)
 
The agency addressed some of the progress that has been made in its quality management maturity (QMM) initiative, which aims to measure the strength of facilities’ quality practices. FDA said it concluded two QMM pilots in February 2022 to develop such benchmarks for domestic finished dosage form manufacturers and international active pharmaceutical ingredient manufacturers.
 
OPQ subsequently published a white paper in April describing the need and considerations for a QMM program and potential impacts on stakeholders. (RELATED: FDA proposes to rate pharmaceutical manufacturing facilities, Regulatory Focus 7 April 2022)
 
In May, FDA held a two-day QMM workshop to discuss the learnings from the QMM pilots. (RELATED: FDA officials reflect on quality maturity model, quality metrics, Regulatory Focus 27 May 2022)
 
In November, an FDA Advisory Committee voted unanimously in favor of establishing a QMM program.
 
FDA has been developing a QMM program since 2019 when an interagency task force proposed the development of a measurement and rating system to measure quality, which would be based on objective indicators to tackle the root cause and potential solutions for drug shortages. (RELATED: FDA Task Force Recommends Rating System for Drug Manufacturing Quality, Regulatory Focus 29 October 2019; FDA proposes to rate pharmaceutical manufacturing facilities, Regulatory Focus 7 April 2022)
 
The report also said that progress has been made in the Knowledge-aided Assessment and Structured Applications (KASA) program to improve and modernize the quality assessment of drug applications.
 
In 2022, OPQ added 16 new analytic features to KASA and used the KASA template to assess over 500 generic drug applications. In November 2022, an FDA Advisory Committee voted unanimously to further expand KASA to assessing new drug and biologics applications.
 
The KASA program was announced in 2019 as part of FDA’s work to improve and modernize the quality assessment of drug applications, and the agency has since said it would take a step-wise approach to implementing KASA in drug reviews. (RELATED: FDA Explains Plans for New Quality Assessment System, Regulatory Focus 16 September 2019; FDA taking incremental approach to launching KASA reviews, Regulatory Focus 5 November 2021)
 
The report also notes that the agency continued to rely on alternative tools, such as requesting information from a facility in lieu of an inspection in 2022, as the COVID-19 public health emergency limited its ability to conduct facility inspections. In 2022, OPQ staff conducted 65 pre-license facility inspections in 18 countries and 10 states and used remote regulatory assessments to act on 85 regulatory submissions. The report stated that “while inspection remains the gold standard, FDA will continue to use remote regulatory assessments to augment inspection activities.
 
In other areas, OPQ highlighted its role in engaging with other international regulators to “coordinate regulatory strategies and develop shared regulatory practices.” OPQ is a participant in two pilot programs with the International Coalition of Medicines Regulatory Authorities (ICMRA) on hybrid inspections and collaborative assessments of post-approval changes. These pilots aim to develop a common framework for international facility assessments and assessing quality-related postapproval changes.
 
OPQ also approved four submissions that included established conditions in 2022, following the release of the International Council for Harmonisation’s (ICH) Q12 guideline the previous year. The Q12 guideline supports the addition of established conditions to ease the process for implementing postapproval changes. (RELATED:  FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers, Regulatory Focus 11 May 2021)
 
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