ICH Q8(R2) - Pharmaceutical Development

What it says

A systematic approach to pharmaceutical development should identify critical quality attributes, critical process parameters and their relationships, optionally defining a design space, the multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality, within which movement does not require further regulatory approval.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Quality by Design shifts emphasis toward building process understanding during development, so that quality is designed into the product and process rather than tested into the finished product afterward.
• A defined design space, if established and included in a regulatory submission, allows a company to move within that space without triggering a formal post-approval change, provided movement stays within the demonstrated boundaries.
• Critical quality attribute and critical process parameter identification requires documented, structured risk assessment, connecting this guideline directly to the quality risk management principles in ICH Q9(R1).

What inspectors look for

• Whether claimed critical quality attributes and critical process parameters are supported by actual development data and risk assessment, not asserted without evidentiary basis.
• Where a design space is claimed, whether operation within that space is genuinely understood and monitored, rather than the design space existing only as a regulatory construct disconnected from real operational practice.
• Whether pharmaceutical development knowledge is retained and available to inform later lifecycle decisions, rather than being lost once initial development and approval are complete.

Related regulations