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Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations

28 September 2015
Drug Substance
Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations
2.17 MB
251 downloads

Errors are a part of life. In a pharmaceutical context, though, errors affect safety and quality and can lead to issues with supply. Direct financial impact from lost batches, investigations, and remediation activities—as well as compliance issues, higher inventory due to late batch releases, or even lost market share—all have to be considered when thinking about total cost of errors. With existing deviations attributed to human error estimated at 50% within the biopharma industry [BioPhorum member survey], the vital importance and real-world value of integrating human performance (HuP) principles is obvious.

Despite the high error rate, resistance to the kind of cultural change needed to improve HuP is rooted in past attitudes and paradigms. For example, it is generally accepted as inevitable that more batches mean more deviations, that higher turnover means more deviations, and that new product introductions mean more deviations. Overall, we deliver products that meet rigorous compliance requirements to our patients and have a positive impact on their lives. So why do anything differently?

We can do better. We want to reduce losses so that our patients receive every volume of product we make. We want to reduce production costs so that we can do more to reinvest in our pipelines of new therapies. We want to continue to reliably deliver to market in a changing and dynamic environment. We want to exceed the expectations of our regulators.

So what do we do to overcome a plateau of good performance and achieve enviable levels of operational performance? In researching our historical deviations, we discover an entry point. Industry data shows 50% of deviations are attributable to human error. We have found internally that despite our best efforts the human error rate has been constant over several years. Comparing ourselves to other high-risk industries with unparalleled levels of reliability, such as nuclear power and aviation, we see that we have changes to make. And those changes are all tied to the integration of HuP into our operations.

This article utilizes the experience of two large, global biotech companies to illustrate pathways to integrate HuP and the benefits realized. It is important to recognize that integration of these principles do not merely address human error, but rather have an overall positive benefit to quality, safety, compliance, and on-time delivery—the critical measures that will make or break a biotech company’s performance.

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Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

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