The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

Health Canada Incorporates QbD in Updated Quality Guidance

Jan. 31, 2014

Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s registration for human use quality standards.

Health Canada Jan. 24 issued draft guidance updating the quality information drugmakers must submit. Among the changes is guidance on how to implement quality-by-design approaches to drug development.

Drugmakers seeking authorization to market brand and generic drugs must:

  • Complete a quality overall summary, which is a condensed summary of the key quality information. According to Health Canada, a summary can help expedite the review process by enabling evaluators to spend time more efficiently on the application;
  • Submit a certificate of suitability if the drug substances or reagents were obtained from a region affected by bovine spongiform encephalopathy or transmissible spongiform encephalopathy agents, neurological diseases transmissible by prions; and
  • Submit drug master files with detailed information on the ingredients and processes used in manufacturing the proposed product. If such materials are proprietary, the supplier can submit a confidential drug master file directly to Health Canada.

Health Canada’s new guidance includes ICH references on how to document a QbD approach to the development of a drug substance. The manufacturer should summarize the risk assessment and results from the design of experiments in the common technical document.
According to the agency, care should be taken to:

  • Use terminology consistent with ICH definitions;
  • Be clear about the claims made using QbD; and
  • Discuss the role of QbD in the overall control strategy.

The draft guidance supersedes three existing documents, including a 2001 draft that was never finalized. The other documents are a 2003 guidance on stability testing and a 2005 draft guidance on impurities.

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