1What quality metrics are.
FDA describes quality metrics as “an objective way to measure, evaluate, and monitor the product and process lifecycle”. Its starting point is that CGMP compliance is the minimum standard, but compliance alone “does not indicate whether a manufacturer is investing in improvements and striving for sustainable compliance”, meaning consistent control over manufacturing performance and quality. Metrics give insight into that performance, and help with supplier selection and with oversight of contract activities and material suppliers.¹
ICH Q10 builds the idea into the pharmaceutical quality system. It calls them performance indicators: “Measurable values used to quantify quality objectives to reflect the performance of an organisation, process or system, also known as ‘performance metrics’ in some regions.”² Q10 asks for performance indicators to be identified and used to monitor the effectiveness of quality system processes, and for indicators that measure progress against quality objectives to be “established, monitored, communicated regularly and acted upon”. Management review of the quality system should assess them, for example for complaint, deviation, CAPA and change management processes, feedback on outsourced activities, audits and regulatory inspections.²
The US drug CGMP regulations contain no metrics requirement as such. The closest is § 211.180(e), which requires records to be kept so that each product’s quality standards can be evaluated at least annually, including a review of a representative number of batches and of complaints, recalls, returned or salvaged product and investigations.³
2Examples of quality metrics.
FDA’s 2022 notice on its reporting programme grouped example metrics into four practice areas. It proposed that each site choose metrics from each area and tell FDA how it calculates them, rather than follow FDA-standardised definitions.⁴
| Practice area | Example metrics from FDA’s 2022 notice |
|---|---|
| Manufacturing process performance | Process capability or performance indices (Cpk/Ppk), lot acceptance rate, right-first-time rate, lot release cycle time |
| PQS effectiveness | CAPA effectiveness, repeat deviation rate, change control effectiveness, overall equipment effectiveness, unplanned maintenance |
| Laboratory performance | Adherence to lead time, laboratory right-first-time rate, invalidated out- |
| Supply chain robustness | On-time in-full, fill rate, disposition on time, days of inventory on hand |
The same notice records what FDA learned from its 2018 pilots, which is useful to anyone designing a metrics programme:⁴
- Different sectors prefer different metrics, so flexibility within critical practice areas works better than one fixed set.
- A metric should be meaningful for the area it measures and able to influence decisions; sometimes a combination of metrics is better than one.
- Lot acceptance rate and invalidated OOS rate are routinely monitored but “are not discerning metrics”, because they vary little over time and can flag performance issues that do not exist.
- Definitions matter: calculating lot acceptance and complaint rates from the 2016 definitions could give rates over 100 per cent or divide by zero, for example because lots are not always dispositioned in the quarter they started.
- Quality culture is hard to capture in numbers alone; numerical indicators such as APR timeliness and near misses can be combined with qualitative summaries.
3FDA’s Quality Metrics Reporting Program.
FDA has been developing a reporting programme for more than a decade, and it has not become a requirement. FDA’s page says the agency “is proposing to develop and implement a Quality Metrics Reporting Program” to support quality surveillance, and that it would use the data to measure manufacturing quality more objectively, integrate it into surveillance and identify products at risk of quality problems such as shortages and recalls.¹ FDA has said the data could support risk-based inspection scheduling, “reducing the frequency and/or length of routine surveillance inspections” for sites whose metrics suggest sustainable compliance.⁴
| Date | Step |
|---|---|
| 2012 | The Food and Drug Administration Safety and Innovation Act gives FDA authority to collect manufacturing records and information from industry as part of risk-based oversight¹ |
| July 2015 | Draft guidance, Request for Quality Metrics: a proposed mandatory, product-based programme with four metrics (lot acceptance rate, product quality complaint rate, invalidated OOS rate and APR on-time rate) and three optional ones⁴ |
| November 2016 | Revised draft guidance, Submission of Quality Metrics Data (81 FR 85226): an initial voluntary phase with three metrics⁵ |
| June 2018 | Quality Metrics Site Visit Program, which toured 14 establishments, and Quality Metrics Feedback Program⁴ |
| March 2022 | Notice and public docket (87 FR 13295) setting out a possible direction: practice areas, site-chosen metrics and establishment-level reporting; comments closed 7 June 2022⁴ |
The 2022 notice said it was “not intended to communicate our regulatory expectations for reporting quality metrics data” but to inform FDA’s future approach.⁴ FDA’s Quality Metrics page, current as of 12 December 2025, still describes the programme as proposed and lists the 2015 and 2016 draft guidances among its historical resources.¹
4Quality Management Maturity.
FDA’s Quality Management Maturity (QMM) Program is related but separate. CDER runs it to encourage manufacturers to adopt quality management practices “that go beyond current good manufacturing practice (CGMP) requirements”, with goals that include fostering quality culture and minimising risks to product availability. FDA describes effective use of quality metrics as one characteristic of robust site QMM.⁶¹
The programme is still in a voluntary prototype stage. CDER assessed nine establishments in 2024, and on 11 February 2026 announced a third cohort of up to nine establishments, with requests accepted until 13 April 2026.⁶ CDER looked for sites that had received at least one human drug surveillance inspection and held a current classification of NAI or VAI. Each assessment takes up to five days with three CDER assessors, who do not come from the Office of Inspections and Investigations that enforces CGMP. The report scores each practice area and gives two or three strengths and two or three opportunities for improvement in each.⁷ CDER’s assessment uses five practice areas, Management Commitment to Quality, Business Continuity, Advanced Pharmaceutical Quality System, Technical Excellence, and Employee Engagement and Empowerment, rated against a five-level rubric.⁸
5How it runs in Seal.
Seal calculates quality KPIs such as deviation rates, CAPA ageing and training status from the underlying records in its QMS, with the period and population defined so a reviewer can inspect the events behind a trend. With automated reporting, each recurring report runs against a defined population, time window and data cut, retains source versions, counting rules and exceptions, and keeps its numerator, denominator, time basis and exclusions with the metric. A signed report stays fixed as later data arrives, and Neil drafts the narrative from the selected records for reviewers to approve.
For supply chain measures, supplier scorecards count on-time and in-full delivery from each receipt line against the date the supplier promised, and quality from inspections and nonconformances, with every number linked to the records it was counted from.
References
- 1Quality Metrics for Drug Manufacturing, FDA, content current as of 12 December 2025. https:/
/ www. fda. gov/ drugs/ pharmaceutical- quality- resources/ quality- metrics- drug- manufacturing (read 6 November 2026) - 2ICH Q10, Pharmaceutical Quality System, sections 1.7, 2.3 and 4.1 and the glossary, ICH, 4 June 2008. https:/
/ database. ich. org/ sites/ default/ files/ Q10%20Guideline. pdf (read 6 November 2026) - 321 CFR 211.180(e), General requirements (records and reports), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- J/ section- 211. 180 (read 6 November 2026) - 4FDA Quality Metrics Reporting Program; Establishment of a Public Docket; Request for Comments, 87 FR 13295, Federal Register, 9 March 2022. https:/
/ www. federalregister. gov/ documents/ 2022/ 03/ 09/ 2022- 04972/ food- and- drug- administration- quality- metrics- reporting- program- establishment- of- a- public- docket (read 6 November 2026) - 5Submission of Quality Metrics Data; Draft Guidance for Industry; Availability, 81 FR 85226, Federal Register, 25 November 2016. https:/
/ www. federalregister. gov/ documents/ 2016/ 11/ 25/ 2016- 28332/ submission- of- quality- metrics- data- draft- guidance- for- industry- availability- request- for- comments (read 6 November 2026) - 6CDER Quality Management Maturity, FDA, content current as of 1 July 2026. https:/
/ www. fda. gov/ drugs/ pharmaceutical- quality- resources/ cder- quality- management- maturity (read 6 November 2026) - 7Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program, 91 FR 6229, Federal Register, 11 February 2026. https:/
/ www. federalregister. gov/ documents/ 2026/ 02/ 11/ 2026- 02768/ voluntary- quality- management- maturity- prototype- assessment- protocol- evaluation- program (read 6 November 2026) - 8An Update on CDER’s Quality Management Maturity Program, presentation at the Generic Drug Forum, FDA, 22 April 2026. https:/
/ www. fda. gov/ media/ 194076/ download (read 6 November 2026)
AQuestions and answers
Is reporting quality metrics to FDA mandatory?
No. FDA proposed a mandatory programme in its 2015 draft guidance, moved to a voluntary first phase in 2016, and in 2022 asked for comments on a more flexible design. FDA still describes the programme as proposed, and no reporting requirement is in force.
What is the difference between quality metrics and Quality Management Maturity?
Quality metrics are the measures themselves, such as lot acceptance or CAPA effectiveness. Quality Management Maturity is a broader CDER assessment of how mature a site’s quality management practices are, scored across five practice areas by a team of assessors. FDA treats effective use of metrics as one sign of a mature site.
What is the lot acceptance rate?
The proportion of lots accepted in a given period. FDA has used it as a measure of manufacturing process performance, but its pilots found it varies little over time, so on its own it may not show where performance is changing.
Which quality metrics should a pharmaceutical site track?
Choose metrics that are meaningful for each area and can change decisions. FDA’s 2022 notice suggests covering manufacturing process performance, quality system effectiveness, laboratory performance and supply chain robustness, and recording exactly how each metric is calculated.
Does ICH Q10 require performance indicators?
ICH Q10 is guidance rather than law, but it says performance indicators should be identified and used to monitor quality system processes, and that management review should assess them. The EU reproduces ICH Q10 in Part III of its GMP Guide, and Chapter 1 says it can be used to supplement the chapter’s contents.