The New Role of PAT as an Integral Part of QbD

In many minds it was only at the turn of the century that both industry and regulatory agencies began to fully comprehend that the ability to meet society's ever increasing healthcare expectations would require a significant step change in the industry's performance.

Over the last 50 years clinical science, engineering science underpinning good manufacturing practice and the analytical science pivotal to the concept of validation  are a few examples of complimentary scientific disciplines which deployed collectively have delivered significantly greater healthcare benefits currently enjoyed by society than they would have if used individually.

Convergence is not new. It has provided the multidisciplinary platforms of complementary sciences underpinning the development of pharmaceutical science for decades.

What has changed is the speed and breadth of development of these complementary sciences and the opportunities these changes offer to totally change the industry's business model.

However in spite of the PAT Guidance, cGMP for the 21st Century and the Critical Path Initiative and latterly QbD which described the "building blocks" to address the key challenges to:

  • encourage and manage innovation while ensuring high quality
  • identify and adopt appropriate technologies which will IMPROVE overall quality
  • successfully shift from empirical to science based standards for manufacturing process quality

7 years later industry is still failing to sponsor the levels of innovation necessary to develop the desired more efficient, agile, flexible pharmaceutical manufacturing sector capable of reliably producing high-quality drug products without extensive regulatory oversight from both regulatory /industry perspectives.

 What hasn't changed is industry / regulatory conservatism

As a direct result:

  • manufacturers have been slow to adopt PAT/QbD
  • the concept of design space is not clearly understood
  • regulatory approaches have not evolved adequately

leading to high levels of regulatory uncertainty within the industry.

Specifications are still based on empirical compendial standards rather than science based on specific process and product need. Concurrently the Pharmaceutical industry has undergone and is still undergoing dramatic change the scale of which few would have predicted. Business performance expectations applying traditional business models are becoming increasingly difficult to sustain. The changes outlined by the critical path initiative previously seen as optional will soon become an imperative.

The Pharmaceutical sciences will not only have to evolve more rapidly but become far more convergent than ever before.

From these perspectives: PAT and QbD are not mutually exclusive they are complementary.

Ken Leiper
Benson Associates, UK
(Member of the Steering Committee of the University of Heidelberg QbD / PAT Conference 2010)

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