FDA: Applications to contain Information described by ICH Q8

As part of its Manual of Policies and Procedures, the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has published a document called "Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review" (MAPP 5016.1), which outlines and clarifies how the chemistry, manufacturing, and controls (CMC) reviewers in FDA's Office of Pharmaceutical Science (OPS) should apply the recommendations in the ICH Q8(R2), Q9, and Q10 guidances to industry. It is applicable for New Drug Applications (NDAs), Investigational New Drug Applications (INDs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs).

The main conclusion is that "OPS CMC reviewers will consider ICH Q8(R2), Q9, and Q10 recommendations when reviewing applications that may or may not include QbD approaches" and that "reviewers should ensure that applications contain at least the minimum information on pharmaceutical development described by ICH Q8(R2)".

Namely, applications should include the following minimal elements delineated in the ICH Q8(R2) Annex:

  • Quality target product profile (QTPP)
  • Critical quality attributes (CQAs) of the drug product
  • CQAs of the drug substance and excipients
  • Selection of an appropriate manufacturing process
  • Control strategy

Additionally, based on the ICH Q8(R2) parent document (page 3) all applications should contain the following:

  • Information that conveys an understanding of the development of the drug product and its manufacturing process
  • Identification of those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality that support the safety and efficacy of the drug product
  • Justifications for the control strategy

"Reviewers should determine whether an application includes sufficient enhanced knowledge that demonstrates the applicant's understanding of material attributes, manufacturing processes, and controls for product quality to support the proposed flexible regulatory approaches."

How to integrate ICH Q8 Elements into Development and CMC Documentation with examples from both small molecules and biotech will be discussed at the ECA Master Class on ICH Q8 in Berlin, Germany, from 5-6 May 2011. You will also learn how to apply the respective paradigms in Pharmaceutical Development to be better able to design strategies for the implementation of ICH Q8 and Quality by Design.

The ICH Guideline Q8(R2) "Pharmaceutical Development" provides information on how to use knowledge gained when applying scientific approaches and quality risk management for developing and manufacturing a product. The annex in ICH Q8(R2) clearer defines key concepts and describes the principles of Quality by Design (QbD) elements. Some of the information described in ICH Q8(R2) represents the minimum amount of information the applicant should provide in an application.

ICH Q9 "Quality Risk Management" provides information regarding systematic approaches to quality risk management.

ICH Q10 "Pharmaceutical Quality System" establishes a model for an effective pharmaceutical quality management.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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