Quality by Design for Biotechnological Products: New FDA Pilot Programme

On 2 July 2008, the FDA issued a docket with the No. FDA-2008-N-0355 in which the FDA is trying to find volunteers from the pharmaceutical industry to participate in a pilot project regarding the submission of documents on quality ("chemistry, manufacturing, and controls") for biotechnological products to the FDA. The data are meant to be submitted in an "Expanded Change Protocol" and to take account of the principles of quality by design and risk-based approaches.

The purpose of this pilot programme is to gain more information on this and also to promote and facilitate the review process for products manufactured by means of biotechnological methods taking account of quality by design and risk-based approaches. This pilot programme concentrates on products reviewed by the FDA Office of Biotechnology Products (OBP) within the Center for Drug Evaluation and Research. The pilot programme is open to submissions of Biologic Licence Applications (BLA) and New Drug Applications (NDA) and supplements to them reviewed by OBP.

Enquiries on the participation in this programme should reach the FDA until 30 September 2008.

Ultimately, the entire programme is one of the measures to implement FDA's Initiative "Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach". Apart from this, the underlying principles can be found in the following guidelines:

  • Pharmaceutical Development (ICH Q 8 and Q8(R1) )
  • Quality Risk Management (ICH Q 9)
  • PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (FDA)
  • Quality Systems Approach to Pharmaceutical CGMP Regulations (FDA)
  • Pharmaceutical Quality Systems (ICH Q10)

The new quality-by-design approach concentrates on quality attributes critical for chemistry, formulation and process design.

Earlier on, in July 2005, the Office of New Drug Quality Assessment (ONDQA) within OPS (CDER, FDA) had already started a comparable pilot programme for medicinal products with small, chemically defined active ingredients. The applicants were meant to demonstrate their knowledge of the products and of the manufacturing processes ("process understanding"). That pilot project was very useful for identifying the appropriate data for submitting a QbD application to the FDA.

Event though in the QbD approach many principles can generally be transferred from small molecules to more complex medicinal products, identifying and evaluating relevant quality attributes is a much greater challenge in case of complex active ingredients.

The OBP pilot project aims to define the clinically relevant attributes for complex products and to link them to the manufacturing process.

The new role of PAT as part of the QbD approach will be in the center of discussions at the PAT Conference 2008 which will be organised by the University of Heidelberg on 28 - 30 October.

The complete document can be found here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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