ICH Q10 PQS Elements and Change Management System

In short: ICH Q10 describes four elements of a pharmaceutical quality system (PQS): process performance and product quality monitoring, CAPA, change management and management review. This guide is for QA staff and students. It explains each element in plain words and shows how its use differs across the product lifecycle.

Overview of the four PQS elements

Many of these elements already exist in regional GMP rules. ICH Q10 aims to strengthen them and support a lifecycle approach to product quality. The four elements are:

1. Process performance and product quality monitoring system
2. Corrective action and preventive action (CAPA) system
3. Change management system
4. Management review of process performance and product quality

Apply each element in a way that is proportionate to the lifecycle stage. The four stages used in ICH Q10 are pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation. Companies are also encouraged to look for innovative ways to improve quality.

1. Process performance and product quality monitoring

The company should plan and run a monitoring system that shows processes stay in a state of control and highlights where to improve. Such a system should:

• Use quality risk management to build the control strategy (parameters and attributes of materials, equipment conditions, in-process controls, finished product specifications, and how often to monitor), allowing timely feedback and feed-forward.
• Provide tools to measure and analyse those parameters, such as data management and statistics.
• Analyse the data to confirm the process remains in control.
• Identify sources of variation so they can be reduced or controlled.
• Include feedback from inside and outside the company, such as complaints, rejections, non-conformances, recalls, deviations, audits and inspection findings.
• Build process knowledge, support the design space where one exists, and enable new approaches to process validation.

Lifecycle application

2. Corrective action and preventive action (CAPA)

A company needs a system to act on findings from complaints, rejections, non-conformances, recalls, deviations, audits, inspections and monitoring trends. Investigations should be structured and aim at the root cause. Effort, formality and documentation should match the risk, consistent with ICH Q9. Good CAPA improves products, processes and understanding.

Lifecycle application

3. Change management system

Innovation, continual improvement, monitoring results and CAPA all lead to change. A company needs an effective system to evaluate, approve and implement changes with a high degree of assurance of no unintended consequences. Formality usually differs before and after the first regulatory submission, because post-submission changes may need regulatory filings.

Depending on the lifecycle stage, the system should:

1. Use quality risk management to evaluate changes, scaled to the risk.
2. Assess each change against the marketing authorisation, design space (if any) and current process understanding, and decide whether a regulatory filing is needed. Working within an approved design space is not a filing change under ICH Q8, but the change system should still evaluate it.
3. Involve expert teams (development, manufacturing, quality, regulatory, medical) so the change is technically justified, and set evaluation criteria beforehand.
4. Evaluate the change after implementation to confirm the objectives were met with no harmful effect on quality.

Lifecycle application

4. Management review

Management review gives assurance that process performance and product quality are managed across the lifecycle. In larger firms it may be several reviews at different levels, with a clear route to escalate quality issues to senior management.

It should consider:

• Results of inspections, audits, other assessments and commitments to authorities
• Periodic quality reviews: customer satisfaction (complaints, recalls), monitoring conclusions, and effectiveness of changes including those from CAPA
• Follow-up from earlier reviews

It should lead to actions such as process or product improvements, resource provision or training, and capture and sharing of knowledge.

Lifecycle application

See also

• Quality risk management in the pharmaceutical industry (ICH Q9)
• Change management system ICH Q10
• SOP on Change Control (example template)
• SOP for Risk Management (example template)

Frequently asked questions

Is ICH Q10 a regulation?

No, it is a harmonised guideline. It is applied through regional GMP expectations and inspections.

Does a change inside the design space need change control?

Under ICH Q10 the company’s change system should still evaluate it, even though no regulatory filing is needed.

How are CAPA and change management connected?

CAPA often results in a change, and the change system then evaluates and implements it and checks the result.

Who should be on the change evaluation team?

People with relevant expertise, such as development, manufacturing, quality, regulatory and medical.

References

1. ICH Q10 Pharmaceutical Quality System, Step 4, 4 June 2008. International Council for Harmonisation. https://database.ich.org
2. ICH Q9(R1) Quality Risk Management, Step 4, 18 January 2023. ICH.
3. ICH Q8(R2) Pharmaceutical Development, Step 4, August 2009. ICH.