Glossary · ICH guidelines
ICH Q8(R2) (pharmaceutical development)
Also known as: ICH Q8, Q8(R2), Quality by design (QbD), Pharmaceutical Development guideline
ICH Q8(R2) is the ICH guideline on pharmaceutical development, in its second revision since 2009. It describes how the development section of a marketing authorization dossier presents product and process knowledge and introduces quality by design, including the quality target product profile, critical quality attributes, design space and control strategy.
- ICH
- Pharma
In one sentence
ICH Q8(R2) covers pharmaceutical development and quality by design: target product profile, critical quality attributes, design space and control strategy.
Example
A tablet developer links dissolution, a critical quality attribute, to granulation moisture and compression force through designed experiments, files a design space for both parameters, and later adjusts compression force within it without a variation.
How it applies
- Quality target product profile (QTPP): The summary of the quality characteristics the product should have, derived from its intended use, route of administration and dosage form.
- Critical quality attributes (CQAs): Physical, chemical, biological or microbiological properties that must stay within limits to ensure the desired product quality. Material attributes and process parameters are linked to them through risk assessment and experiments.
- Design space: The combination of input variables and process parameters shown to provide assurance of quality. Once approved, working within the design space is not considered a change; moving out of it normally starts a post-approval change process.
- Control strategy: The planned set of controls, from material specifications to in-process tests and process monitoring, derived from product and process understanding.
- Technical documentation: The results go into CTD module 3, section 3.2.P.2 (pharmaceutical development). Record the rationale behind each CQA and parameter, not only the chosen values, so later changes can be assessed under ICH Q12.
Enhanced (QbD) vs. minimal approach
ICH Q8(R2) accepts both. The minimal approach sets fixed parameters and relies mainly on end-product testing. The enhanced approach builds systematic understanding and can support a design space, real-time release testing and more flexible post-approval change management. The enhanced approach is not mandatory; the dossier must show which approach was taken.