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Quality by Design: Essential, Not Optional

Neuland-labsIn today’s pharmaceutical industry, Quality by Design (QbD) has become an essential – instead of optional – tool.

In fact, the phrase, “essential instead of optional” reminds me of the Crabtree ad stating, “A switch is a switch.” (The ad emphasizes the importance of quality in a lighthearted way.) Pharma’s quality requirement has a much more serious significance, as it directly affects consumers’ health.

In a pharmaceutical context, QbD is a systematic approach to development that starts with predefined objectives. It emphasizes product & process understanding and process control, based on sound science and quality risk management.

QbD focuses on Quality planning, Quality control and Quality improvement (the J.M. Juran approach) which, further strengthened by Six Sigma – DMAIC (Define, Measure, Analyze, Improve, Control) methods, has helped advance various industries over the past 60 years. These methodologies eventually took hold in the pharma industry about 15 or 20 years ago.

At Neuland, we view QbD as a way to ensure we remain a good, sustainable business. We treat it, however, as a regulatory requirement.

Benefits of Quality by Design

When implemented properly, the various characteristics of QbD—knowledge capture, risk management and quality systems—offer a number of advantages to both sponsors and contractors…and ultimately benefit the patient.

Cost:

  • More accurate planning allows greater supply chain reliability and predictability, which drive down the cost of goods. This can result in better product pricing and increased availability.
  • Faster time to market and reduced rework, resulting in lower costs and higher revenues.

Quality:

  • Increased assurance of product quality.
  • Better-defined processes lead to better facilities, which can improve product reliability and reproducibility.

Speed:

  • Potential compliance actions are reduced or eliminated.
  • Effective knowledge management makes it possible to work smarter and faster to make new therapies available sooner.
  • More opportunities for first-cycle approval.
  • Improved scale-up efficiency and speed.

Efficiency:

  • Streamlines post-approval changes and regulatory procedures.
  • Allows for more focused inspections.
  • Offers opportunities for continual improvement.

Innovation:

  • The ability to use innovative new technologies accelerates change and enables a proactive product lifecycle marketing plan.

Science:

  • Builds a scientific knowledge base for all products.
  • Allows better interaction with industry on science issues.

QbD generates better results – not only in terms of a product’s “processability,” but also by eliminating potentially problematic unknowns when the time comes to scale up production.

Since QbD is a science-based approach, it provides a basis for optimizing and improving manufacturing without having to deal with additional regulatory filings or scrutiny. And when it comes to technology transfer, QbD-generated process understanding can smooth the transition.

Regulatory authorities feel that carrying out incremental, unsystematic improvement in unit operations in isolation ultimately has little effect on overall process performance or quality. To ensure product quality, a more holistic QbD approach should be adopted.

Throughout the process, providing explicit knowledge in a clear, concise, systematically catalogued format with the help of QbD adds a new dimension to customer service and allows companies to differentiate themselves.

Areas of Impact

It encompasses various functions such as technology transfer, control checks, deviation reduction and analytical methods development and improvement. With such a wide scope of impact, QbD renders regulatory authorities more comfortable approving the drug application.

QbD is an essential tool that fosters process understanding, and has proven to be pivotal in ensuring product quality and performance. In fact, with new guidelines in place to facilitate its use, recent NDAs at Neuland have provided numerous opportunities to demonstrate successful implementation of QbD.

Harmonizing Industry and Regulation

Full implementation of QbD is a win-win situation for pharmaceutical companies. The key issue is to understand the scientific principles of QbD and how to correctly implement it. Regulatory authorities also need to harmonize the requirements and understanding across their departments. Only with clear communication between the industry and regulatory bodies can the challenges and concerns associated with implementation be successfully resolved.

 

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