Simon Chalk

Demonstrating good manufacturing practice (GMP) represents a minimum requirement to run biopharmaceutical operations. Failure to comply with GMP, on the other hand, can lead to external intervention and remedial actions, at high cost and risk to reputation. But good practice is not necessarily the same as best practice and regulations do not cover the whole gamut of business processes and systems that affect performance. Much of the good practices used can be described as being "acceptable" to external inspectors, but in most cases, there are better ways of working that still earn regulatory approval.

Is the industry doing enough to proactively search out, internalize, and establish better practices? Or do we mostly allow good or acceptable practice to stay unchallenged and unimproved? In today's tough environment, biopharmaceutical manufacturers cannot afford to ignore the fact that better ways of working might be possible.

Concerns about sharing information with competitors has be put in perspective, however. When companies collaborate, the industry is strengthened and competition is increased. Most importantly, collaboration supports increased quality and patient safety. These benefits easily outweigh the potential loss of advantage where some companies incur higher costs from using poorer practices. There is no real competitive advantage here. Sharing best practice does not mean sharing IP, cost, or commercial information. These are no-go areas.

In a sharing-based environment, most information can be gleaned from other parts of the business or from other companies in the industry. Less common practice is to seek out other industries to learn about their best practices or benchmark their performance levels. And here's the problem: if most of our best-practice sharing is within our company or within similar companies, then we miss out on learning where significant gains can be made. As one senior executive put it to me, "If I'm a C-grade student, I don't just want to learn from a C+ grade friend. I also want to learn from the A-grade student who is going to help me leap forward."

Sharing best practice between players in the industry means improvement comes more quickly. However, if the best practice doesn't exist in the industry how can it be shared and copied? Taking best practice from other industries can bring a step-change in perspective and in performance.

A great example spreading across our industry at the moment are practices associated with people making mistakes in their work and how the resulting problems are dealt with. When mistakes lead to product quality risks, then there is a duty on the part of the manufacturer to identify, correct, and prevent the mistakes from reoccurring. Until recently, the common practice for responding to human error was to retrain the person making the mistake. If this is done correctly and documented, then it is acceptable from a GMP perspective. Good practice? Yes, but is it best practice?

The nature of bioprocessing necessitates a significant amount of manual intervention and the amount of reported human errors in GMP investigations is high. These errors are costly to the industry not only in terms of rework, lost product, and lead time but also in terms of the number of errors that implicate training, supervision, verification, and attention to detail. In such instances, the ability of the industry to identify and address true root causes is questioned. As a result, regulatory concerns have been heightened, and agencies are pushing for a more formal approach to Human Error Reduction (HER).

The shifting environment suggests that past good practice may not be future acceptable practice. So how can better practices associated with human error be found and used?

One only has to look at nuclear or aerospace businesses to realize there are better ways. The worst-case impact of human error in these industries doesn't need to be detailed here, but it is worth mentioning that millions of hours of operation are routinely recorded without accident. Best practices found in nuclear and aerospace operations include the following:

• Near misses are recorded and investigated as learning opportunities.
• Management encourages the highlighting of errors to facilitate improvement rather than punish the guilty.
• Systemic issues are reviewed for root cause analysis and true preventive measures adopted.
• Environmental, behavioral, and psychological factors are assessed in a structured way.