How many controls does ICH Q10 have?

ICH Q10 contains 15 controls organized across 3 domains.

Where does ICH Q10 apply?

ICH Q10 is applicable in International (ICH). Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does ICH Q10 map to?

ICH Q10 has control-to-control mappings with 416 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with ICH Q10 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

ICH Q10 — Pharmaceutical Quality System

ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system (PQS) based on ISO quality concepts, applicable GMP regulations, and ICH Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management). It establishes a system for lifecycle management of pharmaceutical products covering development, technology transfer, commercial manufacturing, and product discontinuation.

Domains

Section 3 - Continual Improvement of Process Performance and Product Quality

Section 2 - Management Responsibility

Section 1 - Pharmaceutical Quality System

Frequently Asked Questions

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