The FDA has produced a revised version of the Q8 pharmaceutical development guidance. This guidance is a revision of the ICH Q8 pharmaceutical development guidelines were published in May 2006.the Q8 guidance describes the suggested contents for the 3.2 .P .2 (pharmaceutical development) section of the regulatory submission in the ICH M4 common technical document (CTD) format.

The pharmaceutical development section provides an opportunity present the knowledge gained with application of scientific approaches and quality and risk management of  the development of a product and its manufacturing process. This documentation is first produced for the original marketing application and can be updated to support new knowledge gained of the life-cycle of a product. the pharmaceutical development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviews and inspectors. The guidance also indicate areas where the demonstration of greater understanding the pharmaceutical Manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicted on level relevant scientific knowledge provided.

This guidance does not apply to contents of submissions of the drug product during the clinical research stages of drug development. However, the principles in this guidance are important to consider during all stages as well. This guidance might also be appropriate for the types of products.

The guidance goes through each of the sections in turn and describes the relevant content the regulators expect to see in that section:

• II a pharmaceutical development (2)
  • A. Component of the drug product (2.1)
    • 1. Drug substance (2.1.1)
    • 2. Excipients (2.1.2)
  • B. Drug product (2.2)
    • 1. Formulation development (2.2.1)
    • 2. Overages (2.2.2)
    • 3. Physicochemical and biological properties (2.2.3)
  • C. Manufacturing process development (2.3)
  • D. Container closure system (2.4)
  • E. Microbiological attributes (2.5)
  • F. Compatibility (2.6)

The guidance is so specific as to render any summary redundant readers are directed to download the entire document by clicking this link.

The bulk of changes to the document and incorporated in an annexe at the back of the guidance, this annex provides further clarification of key concepts outlined in Q8 pharmaceutical development. In addition, this annex describes the principles of quality by design. The annex is not intended to establish new standards or to introduce new regulatory requirements; however, it shows how concepts and tools outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.

this annex suggests strategic and quality systems that a company can adopt at the very start of the drug discovery programme, it describes approaches to pharmaceutical development, that the FDA and the International commission on harmonisation (ICH) would recommend for any company developing a pharmaceutical product with a significant commitment to quality. The guidance goes on to describe a number of elements that should be included at a minimum:

• quality target product profile (QTPP)
• critical quality attribute (CQAs)
• determination of critical quality attributes
• selection of appropriate manufacturing process
• risk assessment
• and definition of equality strategy

Each of these strategies in elements and described in some detail, the FDA go to great pains to point out that this is not a regulatory framework, better recommended system that they believe will ensure increased quality. I believe this documentation to be of such critical nature is to be recommended reading for anybody working in the area of drug development of discovery.

Please expect a more detailed review to this document to be published on this site.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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