ICH Q10: what it is, who needs it, and how a pharmaceutical quality system works

What is ICH Q10?

ICH Q10 is the International Council for Harmonisation's model for a pharmaceutical quality system, covering drug substances and drug products, including biologics, from development to discontinuation. It builds on GMP, ISO quality management concepts, ICH Q8 and Q9. The FDA and the EMA adopted it as guidance, so inspectors read a quality system against it. There is no Q10 certificate.

It reached ICH Step 4 in June 2008. The FDA published it as guidance for industry in April 2009, and the European Commission rewrote Chapter 1 of EU GMP around it in 2013 under the title Pharmaceutical Quality System. There is no newer revision.

Who needs ICH Q10?

Manufacturers of drug products and active pharmaceutical ingredients, including biologics, who run a quality system under 21 CFR 210 and 211 or EU GMP, since both regulators read that system against Q10's elements

Biotech and pharma companies moving from development into technology transfer and commercial manufacturing, the two lifecycle stages where the quality system has to exist before the first commercial batch

Contract manufacturers and the sponsors who use them, since Q10 holds the product owner responsible for the quality system that governs outsourced work, through the quality agreement

The guideline becomes urgent when the pre-approval inspection goes on the calendar, when the quality agreement with a CDMO asks whose change management system governs a process change, or when an inspector asks for the last management review and the minutes are an email thread.

What ICH Q10 expects, element by element

Q10 holds senior management responsible for three outcomes, product realisation, a state of control and continual improvement. The system that delivers them is four elements and two enablers, applied at every lifecycle stage.

A system that tracks process performance and product quality through the lifecycle, feeds the data into trending, and shows where the process is drifting and where improvement is needed

A CAPA system that investigates complaints, deviations, nonconformances, recalls, audit findings and trends, with the investigation sized to the risk and the outcome fed back into the product and the process

A system that evaluates every proposed change for its impact on product quality before it is made, applies quality risk management to the evaluation, routes the approval to the right people and checks the change did what it was meant to after implementation

Senior management reviews the results of monitoring, CAPA and change at planned intervals and decides the resources and the improvements that follow

The two enablers that run through all four elements, product and process knowledge gathered from development to discontinuation, and risk assessed, controlled and reviewed under ICH Q9

Pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation, with each element applied in the way that fits the stage

How a pharmaceutical quality system under Q10 works

1. Read the quality system you have against Q10's elements

GMP already requires most of what Q10 describes, so list where each element and enabler exists as a written procedure, and where it exists only as practice.

2. Write or revise the procedures the gaps call for

How a deviation is investigated and trended, how a change is assessed and approved, what the management review covers and how often it meets, then train the people who run them.

3. Run the elements and keep the records

Trends from monitoring, CAPAs closed with their effectiveness checked, changes assessed for risk before approval, and management reviews held at planned intervals with minutes and actions.

4. Extend it across the lifecycle and to outsourced work

5. Be ready for the inspection

An FDA investigator or an EU inspector reads the elements through the records, from the deviation trend to the CAPA that followed and the management review that saw both.

ICH Q10 IN QUALIO

Qualio maps your CAPAs and change controls to Q10's elements, so the management review reads the records as they stand

Qualio breaks ICH Q10 down element by element, beside cGMP in the same library, and maps your deviations, CAPAs, change controls and procedures to the elements they answer. When a record changes, it reassesses those elements and recommends a fix for any gap. Copilot drafts the deviation write-up or the CAPA investigation from the recommendation, and your team approves it. When the inspector asks, you export the evidence by element.

CAPAs opened from the deviation, complaint or audit finding that raised them, each traceable to the record that raised it, for the CAPA element

Change controls with the procedures, specifications and validation documents linked before anyone approves, and the retraining out on the effective date, for change management

Management review run as an event at the interval your procedure sets, with the actions it raises tracked as tasks on the event, each assigned and dated

Standards that apply alongside ICH Q10

Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA regulation Q10 sits on, and the source of the deviation, CAPA and change records its elements are read through
Pharma manufacturingEU GMP, Eudralex Volume 4: Chapter 1 was rewritten around Q10 as the pharmaceutical quality system, so an EU inspector reads the same elements as GMP
Pharma manufacturingICH Q9: The quality risk management Q10 names as an enabler, applied inside every element from the deviation investigation to the change assessment
Pharma manufacturingICH Q8: Pharmaceutical development, whose product and process knowledge is what Q10's knowledge management carries into technology transfer and manufacturing
Pharma manufacturingICH Q7: GMP for active pharmaceutical ingredients, the drug substance half of the lifecycle Q10 covers

iMIX

iMIX is a pharmaceutical company based in New Zealand that provides tailored medicines directly into hospital settings.

Read the iMIX story

“My favourite thing is how Qualio keeps us in a constant state of audit readiness.”

Deb G.Director of Quality, Dimension Therapeutics

Guides and checklists for ICH Q10

Toolkit

ICH Q10 toolkit

Checklist

ICH Q10 compliance checklist

Guide

How to prepare for ICH Q10 compliance

Questions about ICH Q10

What is ICH Q10?

ICH Q10 is the International Council for Harmonisation's model for a pharmaceutical quality system, covering drug substances and drug products from development to discontinuation. It describes four elements, monitoring, CAPA, change management and management review, and two enablers, knowledge management and quality risk management. The FDA and the EMA adopted it as guidance.

Is ICH Q10 mandatory?

No. It is a guideline, GMP is the law, and Q10 says itself that what it describes beyond regional GMP is optional. In practice EU GMP Chapter 1 is written around it and FDA investigators read the system through its elements, so a company that complies with Q10 is answering the questions an inspector will ask.

What are the four elements of ICH Q10?

Process performance and product quality monitoring, corrective action and preventive action, change management, and management review of process performance and product quality. Each applies at every stage of the lifecycle, and each runs on the two enablers, knowledge management and quality risk management. Together they are what an inspector reads the quality system through.

What is the difference between ICH Q9 and ICH Q10?

Q9 is the quality risk management guideline, the method for assessing, controlling, communicating and reviewing risk. Q10 is the quality system model that uses it, naming quality risk management as one of the two enablers behind every element. A company complies with Q10 by applying Q9 inside its CAPA, change management and monitoring.

What are the lifecycle stages in ICH Q10?

Four. Pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation. Q10 asks that the quality system cover all of them, with each element applied in the way that fits the stage, so the knowledge gained in development reaches manufacturing and the records of a discontinued product are kept for as long as the regulation requires.

Does ICH Q10 apply to contract manufacturers?

Yes. Q10 makes the product owner responsible for the quality system that governs outsourced work, through a written quality agreement that says who does what, how changes are managed and how performance is monitored. The CDMO runs its own system under GMP, and the owner's system has to see into it.

Can we add ICH Q10 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every element, beside cGMP or EU GMP if you run those too. The deviations, CAPAs and change controls that answer the GMP regulations count towards Q10 without being re-filed, and the first assessment lists what is covered and what is new.

When is the next management review?

Bring the date and your procedures. We will show you ICH Q10 assessed against them element by element, with the gaps listed and the management review run as an event.

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