The Role of Analytical Science in Implementing Quality by Design - Pharmaceutical Technology

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The Role of Analytical Science in Implementing Quality by Design
The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.


Pharmaceutical Technology
Volume 37, Issue 3, pp. 74-77, 80

PDA workshop on analytical science and QbD

The Parenteral Drug Association (PDA) organized a workshop, held on Mar. 6–7, 2012, aimed at identifying the role analytical science plays in supporting the implementation of quality-by-design (QbD) concepts and some of the challenges and opportunities QbD creates. The workshop provided a forum for regulated industry and key stakeholders from regulatory authorities (FDA, European Medicines Agency, and the UK's Medicines and Healthcare products Regulatory Agency) and pharmacopeias (European Pharmacopoeia, British Pharmacopoeia) to explore the implications of QbD on analytical science and to assess the future direction and implementation challenges. Diverse representation including analytical scientists and regulatory affairs staff involved in development and manufacturing engaged in an open exchange of ideas during the three topic breakout sessions and the plenary panel discussions conducted over two days. Challenges and issues were identified for topics covering:

  • How the critical product and process attributes that are measured change with a QbD approach
  • The implications of QbD on specification limits and sampling
  • How QbD concepts can be applied to analytical methods development and how this affects method validation approaches
  • How implementation of improved and innovative methodologies can be facilitated
  • The challenges of global alignment of standards.

The workshop participants suggested a number of potential actions that might help address these challenges including:

  • Agreeing on unique, unambiguous, and well-defined terminology
  • Reviewing existing International Conference on Harmonization (ICH) guidelines, and developing a white paper on proposed revisions and potential new guidelines, if any, that would support and enhance the role of analytical methods in QbD
  • Exploring, during the forthcoming revision to the EU variations guidance, how the Post-Approval Change Management Concept might be used to facilitate continuous improvement and innovation of analytical methodology
  • Establishing mechanisms to ensure global alignment of new pharmacopoeial\regulatory texts and guidance in this area (e.g., large sample size guidance and method validation)
  • Developing case studies and aligned terminology to ensure consistent understanding of how QbD can be applied to analytical methods and further explore how analytical target profile (ATP) can be presented in regulatory submissions
  • Holding further workshops in the US and in Asia focusing on case studies in order to support global alignment of concepts.

At the PDA workshop, Bernadette Doyle, vice-president, technical, GMS within GSK, presented an industry view on the ideal future state as:
  • Every test performed adds real value in assuring patient safety, product quality, and process robustness
  • Analytical processes (e.g., method development, validation, transfer, change management, issue resolution) are fit for purpose and underpinned by a science- and risk-based approach
  • Analytical methods are robust, continuously improved across the product lifecycle, and reflect best-in-class technology
  • Knowledge is maintained and refreshed to support future learning and analyst competency
  • Continuous improvement of analytical methods is not constrained by regulatory barriers
  • There are clear and appropriately harmonized standards (or mutual acceptance) of analytical measurement activities across all markets.

Phil Nethercote* is head of analytical and API analytical lead, GMS, at GSK. Graham Cook is senior director process knowledge/quality by design at Pfizer. Moheb Nasr is vice-president, CMC regulatory strategy at GSK. Siegfried Schmitt is senior consultant at PAREXEL. Lucinda Buhse is director of the division of pharmaceutical analysis at FDA.

*To whom all correspondence should be addressed.


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