1What a management review is.
ICH Q10 makes senior management “responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness”.¹ It describes two reviews: a management review of process performance and product quality (section 3.2.4), and a formal, periodic review of the pharmaceutical quality system itself (section 4.1). Depending on the size and complexity of the company, the first “can be a series of reviews at various levels of management”, with escalation of quality issues to senior management.¹
EU GMP Chapter 1 asks for “periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself”, and reproduces ICH Q10 in Part III of the EU GMP Guide.² WHO’s GMP text uses almost the same words.³ FDA’s 2006 quality systems guidance calls the activity reviewing the system: senior managers review the quality system’s performance “according to a planned schedule” to ensure its “continuing suitability, adequacy, and effectiveness”.⁴
For medical devices, management review is clause 5.6 of ISO 13485:2016,⁵ which the FDA Quality Management System Regulation has incorporated by reference since 2 February 2026.⁶⁷ MDSAP’s audit approach, which FDA publishes on its MDSAP pages, has auditors verify that management review procedures are documented and that reviews take place at planned intervals and cover the suitability and effectiveness of the quality policy, quality objectives and quality management system.⁸
2The inputs.
| Input | ICH Q10 | FDA guidance (2006) | MDSAP audit approach |
|---|---|---|---|
| Inspections, audits and other assessments | Results of regulatory inspections and findings, audits and other assessments; self-assessments and customer audits | The results of audits and other assessments | Results of internal and external audits |
| Commitments to regulators | Commitments made to regulatory authorities | Not listed | Not listed |
| Complaints and customer feedback | Product quality complaints and recalls | Customer feedback, including complaints | Customer feedback |
| Process and product performance | Conclusions of process performance and product quality monitoring | The analysis of data trending results; product characteristics meeting the customer’s needs | Process performance and product conformity |
| CAPA and change | Effectiveness of process and product changes, including those arising from CAPA; indicators for complaint, deviation, CAPA and change management processes | The status of actions to prevent a potential problem or a recurrence | Status of preventive and corrective actions |
| Policy and objectives | Achievement of quality system objectives | The appropriateness of the quality policy and objectives | Quality policy and objectives reviewed for continued suitability |
| Changes around the system | Emerging regulations and guidance, innovations, changes in business environment and in product ownership | Changes in business practices or environment that may affect the quality system | Changes to regulatory requirements; changes that could affect the quality management system; recommendations for improvement |
| Outsourced work | Feedback on outsourced activities | Not listed | Not listed |
| Earlier reviews | Follow-up actions from previous management reviews | Any follow-up actions from previous management reviews | Follow-up actions from previous management reviews |
The ICH Q10 column draws on sections 3.2.4, 4.1 and 4.2;¹ the FDA column on the guidance’s section on reviewing the system;⁴ and the MDSAP column on task 9 of its management chapter.⁸
3The outputs.
ICH Q10 lists the actions a management review of process performance and product quality should identify: improvements to manufacturing processes and products; provision, training or realignment of resources; and capture and dissemination of knowledge. The review of the quality system can lead to improvements to the system and its processes, allocation or reallocation of resources and training, revisions to the quality policy and objectives, and “documentation and timely and effective communication of the results of the management review and actions, including escalation of appropriate issues to senior management”.¹
FDA’s guidance says the results of a management review “would typically be recorded”, and that planned actions should be implemented through corrective and preventive action and change control procedures.⁴ MDSAP auditors confirm that the dates and results of reviews are documented, and that action items from management review are considered for corrective or preventive action.⁸
4How often it must happen.
| Source | Frequency |
|---|---|
| ICH Q10, 4.1 | A formal process for reviewing the quality system “on a periodic basis”.¹ |
| EU GMP Chapter 1, 1.6 | “Periodic management review, with the involvement of senior management”.² |
| WHO TRS 986 Annex 2, 1.6 | “Unless otherwise justified, such reviews should be conducted at least annually.”³ |
| FDA guidance (2006) | “According to a planned schedule”, more frequently while a quality system is new than once it has matured, and as a standing item in general management meetings.⁴ |
| MDSAP audit approach, task 9 | At planned intervals, “at defined intervals and with sufficient frequency” to ensure the system meets applicable requirements.⁸ |
Of these, only WHO names a default interval. Otherwise the company sets the interval in its procedure and has to show that it is often enough.
5Who can see the record.
For medical devices, FDA can now inspect management review reports. The old Quality System regulation let manufacturers withhold management review, quality audit and supplier audit reports from FDA investigators under 820.180(c); the QMSR does not keep that exception, and FDA says it will review such records on or after 2 February 2026.⁷ FDA’s device inspection programme lists management review among the elements its investigators evaluate, mapped to ISO 13485 clauses 5.6.1 to 5.6.3.⁹
6How it runs in Seal.
In Seal the records a management review draws on are the quality records themselves. The audit programme supplies audit and inspection results, commitments to authorities with their owners and due dates, customer audits, effectiveness reviews and follow-up still open from earlier reviews, so the review reads them from the programme rather than from a summary assembled for the meeting. The QMS calculates quality KPIs such as deviation rates, CAPA ageing and training status from the underlying records.
Automated reporting runs a recurring report against a defined population, time window and data cut, keeps the source versions and counting rules with the run, and turns agreed findings into assigned follow-up linked to the issued report. A signed report stays fixed as later data arrives, and management reviews and annual product reviews can use related definitions while keeping their purpose and approval requirements distinct.
References
- 1ICH Q10, Pharmaceutical Quality System, sections 2.6, 3.2.4 and 4, ICH, 4 June 2008. https:/
/ database. ich. org/ sites/ default/ files/ Q10%20Guideline. pdf (read 6 November 2026) - 2EudraLex Volume 4, Chapter 1: Pharmaceutical Quality System, sections 1.2 and 1.6, European Commission, in operation since 31 January 2013. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ vol4- chap1_ 2013- 01_ en_ 0. pdf (read 6 November 2026) - 3WHO good manufacturing practices for pharmaceutical products: main principles, WHO Technical Report Series No. 986, Annex 2, section 1.6, World Health Organization, 2014. https:/
/ cdn. who. int/ media/ docs/ default- source/ medicines/ norms- and- standards/ guidelines/ inspections/ trs986annex2. pdf (read 6 November 2026) - 4Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, section IV.A.5, FDA, September 2006. https:/
/ www. fda. gov/ media/ 71023/ download (read 6 November 2026) - 5ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purposes, table of contents, ISO Online Browsing Platform. https:/
/ www. iso. org/ obp/ ui/ en/ #iso:std:iso:13485:ed- 3:v1:en (read 6 November 2026) - 621 CFR 820.10, Requirements for a quality management system, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- H/ part- 820/ subpart- A/ section- 820. 10 (read 6 November 2026) - 7Quality Management System Regulation: Frequently Asked Questions, question 8, FDA, content current as of 5 November 2026. https:/
/ www. fda. gov/ medical- devices/ quality- management- system- regulation- qmsr/ quality- management- system- regulation- frequently- asked- questions (read 6 November 2026) - 8MDSAP AU P0002.009, MDSAP Audit Approach, chapter 1, task 9, Medical Device Single Audit Program, revision date 6 August 2024, on FDA’s MDSAP audit procedures page. https:/
/ www. fda. gov/ media/ 166672/ download (read 6 November 2026) - 9Compliance Program 7382.850, Inspection of Medical Device Manufacturers, FDA, implementation date 2 February 2026. https:/
/ www. fda. gov/ media/ 80195/ download (read 6 November 2026)
AQuestions and answers
Who should attend a management review?
Senior management has to be involved: EU GMP asks for periodic management review with its involvement, and ICH Q10 makes it responsible for governing the quality system through management review. In a larger company the review can be a series of reviews at different levels of management, with a clear route for escalating quality issues to senior management. The procedure should name the attendees.
Is a management review the same as an annual product review?
No. A product quality review looks at one product’s batches, deviations, changes, stability, complaints and recalls. A management review looks at the quality system as a whole and assesses the conclusions of those product reviews, alongside audits, inspections, CAPA and the quality objectives.
Can FDA inspectors see management review records?
For medical devices, yes. Under the QMSR, effective 2 February 2026, the exception that let device manufacturers withhold management review, internal audit and supplier audit reports from FDA no longer applies, and FDA says it will review them during inspections.
What should management review minutes record?
The date, the inputs reviewed, the conclusions and the actions decided, with who owns each action and how it will be followed up. FDA’s guidance expects the results to be recorded and the actions carried through CAPA and change control, and ICH Q10 expects the results to be documented and communicated.
Can a small company hold one review a year?
Usually, yes. WHO expects management reviews at least annually unless otherwise justified, ICH Q10 and EU GMP leave the interval to the company, and device auditors check that reviews happen at the planned intervals. FDA suggests reviewing more often while a quality system is new, and the interval has to be often enough to keep the system suitable and effective.