Glossary · ICH guidelines
ICH Q10 (pharmaceutical quality system)
Also known as: Q10, Pharmaceutical quality system (PQS), PQS
ICH Q10 is the ICH guideline, adopted in 2008, that describes a model pharmaceutical quality system (PQS) for the whole product lifecycle, from development and technology transfer through commercial manufacturing to product discontinuation. It builds on GMP and ISO quality management concepts and complements ICH Q8 and Q9.
- ICH
- Pharma
- GxP
In one sentence
ICH Q10 describes a pharmaceutical quality system across the product lifecycle, built on GMP, quality risk management and knowledge management.
Example
A generics manufacturer structures its management review under ICH Q10, reviewing process performance and product quality trends, CAPA effectiveness and change management outcomes for each product family once a year.
How it applies
- Four elements: Process performance and product quality monitoring; corrective and preventive action; change management; and management review of process performance and product quality.
- Two enablers: Knowledge management and quality risk management.
- Management responsibility: Senior management is responsible for the quality policy, resources and the effectiveness of the quality system, including oversight of outsourced activities and purchased materials.
- Lifecycle: The same system spans pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation, so that knowledge gained in one stage informs the next. In the EU, ICH Q10 is published in Part III of EU GMP.
- Technical documentation: A quality manual describing the PQS, its scope and processes, plus records of management reviews, CAPA and changes. Content of ICH Q10 that goes beyond regional GMP requirements is optional, but an effective PQS is a precondition for the flexibility offered by ICH Q12.
ICH Q10 vs. ISO 13485
Both are process-based quality system models. ICH Q10 is guidance for medicines manufacturers and sits on top of binding GMP rules. ISO 13485 is a certifiable standard for medical device organizations, harmonized under the MDR and IVDR and incorporated by reference in the FDA QMSR.