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ICH Q10 pharmaceutical quality system, explained
ICH Q10 is the international guideline that describes a pharmaceutical quality system: the way a company organises quality across the whole life of a product, from development to discontinuation. It builds on GMP and adds what GMP alone does not say: senior management owns quality, the system must improve itself, and four elements must work together. Those elements are process monitoring, CAPA, change management and management review, supported by knowledge management and quality risk management. Regulators in Europe, the United States and Japan adopted it in 2008.
- 4 related courses
- 40 hours of audio across them
- certificate and training record
- delivered in 72 hours
What are the ICH Q10 guidelines trying to achieve?
ICH Q10 names three objectives: achieve product realisation, establish and maintain a state of control, and facilitate continual improvement. Put simply, make the product as intended, know that you are doing so, and get better at it over time. It applies across four lifecycle stages: pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation.
What does an ICH Q10 pharmaceutical quality system contain?
Four elements do the work.
- A process performance and product quality monitoring system: trend the data that tells you whether the process is in control, not only whether batches pass.
- A CAPA system: investigate deviations, complaints, audit findings and trends, fix the cause and check that the fix worked.
- A change management system: assess every change for risk before it is made, approve it, and confirm afterwards that it did what was intended.
- Management review: senior management looks at all of the above on a schedule and decides.
Two enablers sit underneath: knowledge management and quality risk management. Knowledge management means what the company learns about its product and process is captured and used. Quality risk management is ICH Q9.
Why do inspectors care about ICH Q10?
Because the four elements are where problems either get caught or get buried. An inspector who sees the same deviation repeated over two years will open the CAPA record, then the management review minutes, to find out whether anyone senior knew. A quality system that exists only as a manual fails that test, however good the manual.
How does a small or mid-size company build one?
Start from what you already have. Most GMP sites run deviations, change control and some form of annual product review. Q10 asks you to connect them: trends feed CAPA, CAPA feeds change control, all three feed management review, and the review produces decisions with owners and dates. The courses below walk through that build, by role, with a recorded questionnaire at the end of each module.
This guide belongs to Training for Quality assurance and Qualified Person in pharma: 257 audio courses, 257 courses.
Courses that teach this, priced per learner per year
Each course is audio modules in three lengths, with workbook, transcript, a recorded questionnaire per module, a certificate and the training record. Prices are the list price per learner for a year; the price falls with more learners.
- ICH Q10 for a company that is not Pfizer: a Pharmaceutical Quality System built from scratch12 modules · 12 hours of audio · QA, management · 108 EUR per learner per year
- Change control and ICH Q9 risk management: doing it daily, not just for the audit8 modules · 8 hours of audio · QA, production · 72 EUR per learner per year
- Deviation, CAPA, root cause: the investigation a European inspector actually believes10 modules · 10 hours of audio · QA, production · 90 EUR per learner per year
- Day one, the inspectors arrive: how an EMA or national GMP inspection really runs10 modules · 10 hours of audio · QA, production, management · 90 EUR per learner per year
Questions about ICH Q10
What are the four elements of ICH Q10?
A process performance and product quality monitoring system; a corrective action and preventive action system; a change management system; and management review of process performance and product quality.
Is ICH Q10 mandatory?
It is a guideline, not a regulation. In practice European inspectors expect it: EU GMP Chapter 1 was rewritten to follow the same model, and it is published as part of the EU GMP guide.
What does ICH Q10 say about senior management?
That senior management is responsible for an effective quality system: setting the quality policy, providing resources, making sure problems are escalated, and reviewing the system regularly. Quality cannot be delegated entirely to the quality department.
How is ICH Q10 different from ISO 9001?
ICH Q10 is based on ISO quality concepts but is written for medicines. It assumes GMP is already in place and adds the product lifecycle, the link to regulatory filings, and the pharmaceutical meaning of change and CAPA.
Does a small company need the same system as a large one?
It needs the same elements, scaled to its size. A company of forty people can run management review in one meeting a quarter, provided it uses real data and the decisions are recorded and followed up.
Is the course certificate an ICH Q10 certification?
The certificate records that a named person completed the course and its questionnaires, with hours, guideline version and date. It is evidence of training for your auditor. It is not a professional qualification or an accreditation.
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