ICH Q8: what it is, who needs it, and how pharmaceutical development is assessed

What is ICH Q8?

ICH Q8 (R2) is the International Council for Harmonisation's guideline on pharmaceutical development. It describes what the pharmaceutical development section of a marketing application contains, Module 3.2.P.2 of the Common Technical Document, and how quality by design is presented in it. Compliance is shown in the dossier, to the regulatory assessor who reads the application. Nobody certifies against Q8.

Q8 reached ICH Step 4 in November 2005, the annex on quality by design followed in November 2008 and the combined text, Q8 (R1), was corrected as Q8 (R2) in August 2009. The FDA published Q8 (R2) as guidance in November 2009. Q8 is read at assessment of the application, so its questions arrive on the assessor's list, and the site inspection reads the process under GMP.

Who needs ICH Q8?

Companies preparing a marketing application for a drug product, since the pharmaceutical development section of Module 3 is written to Q8 whether development took the minimal approach or the enhanced one

Companies proposing a design space, since the assessor approves it with the application, and from then on moving within it needs no regulatory change while moving outside it starts a post-approval change

Biotech and pharma companies moving from clinical development into commercial manufacturing, and the CDMOs who do development work for them, since Q8 does not apply during the clinical phases and the knowledge gathered there is what the section is written from

The guideline becomes urgent when Module 3 is being assembled and the development section is the one nobody has written, when the assessor's question list asks how a specification was justified, or when a post-approval change lands and someone has to say whether it stays inside the design space.

ICH Q8 IN QUALIO

Qualio maps your development reports and control strategy to Q8's elements, so the dossier is written from approved documents

Qualio breaks ICH Q8 down element by element, beside Q9, Q10 and Q11, and maps your development procedures, reports, risk assessments and control strategy to the elements they answer. When a document changes, it reassesses those elements and recommends a fix for any gap. Copilot drafts the change control for a post-approval change, and your team approves it. When the assessor's questions arrive, you export the evidence by element.

The quality target product profile, the critical quality attributes and the development reports behind them held as controlled documents at their approved versions, for the development section of the dossier

The risk assessments that link material attributes and process parameters to each critical quality attribute held in the risk register with their reviews and approvals, one set of risks for quality and for the product

The control strategy as a controlled document with the specifications and procedures it depends on linked, so a revision goes to the approvers your procedure names and the retraining goes out on the effective date

Post-approval changes run as change controls with the design space and the control strategy linked before anyone approves, so whether a change stays inside the design space is decided on the approved version

Standards that apply alongside ICH Q8

Pharma manufacturingICH Q9: The quality risk management Q8 relies on to link material attributes and process parameters to the critical quality attributes, and to decide how much control each one needs
Pharma manufacturingICH Q10: The pharmaceutical quality system that carries the knowledge gained in development into technology transfer and commercial manufacturing, and runs the change management a design space depends on
Pharma manufacturingICH Q11: The development and manufacture of the drug substance, written in the same quality by design terms for the active ingredient Q8's drug product is made from
Pharma manufacturingcGMP (21 CFR 210 and 211): The regulation the commercial process runs under once the application is approved, where the control strategy becomes the specifications and procedures an FDA investigator inspects
Pharma manufacturingEU GMP, Eudralex Volume 4: The European GMP guidelines, whose Chapter 1 expects product and process knowledge from development to be managed across the lifecycle

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Guides and checklists for ICH Q8

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Questions about ICH Q8

What is ICH Q8?

ICH Q8 (R2) is the International Council for Harmonisation's guideline on pharmaceutical development. It describes what the pharmaceutical development section of a marketing application contains and sets out quality by design, a systematic approach that starts from predefined objectives and builds product and process understanding on science and quality risk management. The FDA and the EMA adopted it as guidance.

Is ICH Q8 mandatory?

No. It is a guideline, and Q8 says the applicant can take an empirical or a more systematic approach and ties regulatory flexibility to the knowledge submitted. In practice the assessor reads the development section against Q8 whichever approach you took, and a design space can only be approved if it was developed and presented the way the annex describes.

What does the ICH Q8 annex cover?

The quality by design annex sets out six elements: the quality target product profile, the critical quality attributes of the product, the risk assessment that links material attributes and process parameters to those attributes, the design space, the control strategy, and lifecycle management of the product and process after approval.

What is a design space in ICH Q8?

The combination of material attributes and process parameters that has been shown to give a product of the required quality, across the ranges studied. The applicant proposes it in the application and the assessor approves it with the dossier. Working inside an approved design space needs no regulatory change. Moving outside it starts a post-approval change.

What is the difference between ICH Q8 and ICH Q11?

Q8 covers the drug product, the finished dosage form, and the pharmaceutical development section of the application, Module 3.2.P.2. Q11 covers the drug substance, chemical or biotechnological, and its development and manufacture in Module 3.2.S. Both use the same quality by design terms, so the critical quality attributes and control strategy of the substance feed those of the product.

Can we add ICH Q8 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the documents you already hold against every element, beside the other ICH quality guidelines you run. The development reports, risk assessments and change controls that answer Q10 count towards Q8 without being re-filed, and the first assessment lists what is covered and what is new.

When does the dossier go in?

Bring the date and your development reports. We will show you ICH Q8 assessed against them element by element, with the gaps listed and the control strategy held with its approvals.

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