The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.
We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.
Quality, as it relates to clinical trials, is defined as an absence of errors that matter to decision-making. Therefore, quality by design (QbD) literally translates into an absence of errors that matter to decision-making by design. This proactive approach to quality continues to gain global and regulatory support. In fact, on May 8, 2019, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft revision of ICH E8 (R1), General Considerations for Clinical Studies.
When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?
The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.
In writing my last article about whether the life sciences industry has driven out people’s ability and motivation to think, I was reflecting on one of the most insightful comments I ever received. I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. This led to a variety of process and cultural issues, because the desire for speed led to broken systems loaded with Band-Aids, corners being cut, people making mistakes, and more — which in turn created a poor quality culture within the company and led to deviations, scrap, and other problems.
Successful implementation of quality by design (QbD) can lead to significant revenue growth and margins from the shortened development cycle. However, in our recent reports on the state of ICH Q8-11 guideline adoption in the industry, we confirmed that, despite the sound rationale of the new operating paradigms, industry uptake has been slow since the publication of the guidances nearly a decade ago.