Holding the Line on Good Laboratory Practices

By

Mark LanfearThe mistakes we all made coming up in the industry—the “freshman effect”—were almost unavoidable. Checking and rechecking kept us in check, and this was our go-to strategy as we became experts. That safety net all comes down to the three schoolhouse Rs, and it can save our industry a significant amount of money.

Why? The biggest pharmaceutical companies spent billions on research and development last year, and the money was largely invested in the three main processes needed under the stringent controls of the manufacturing of medicines: lab testing, preclinical testing, and clinical trials.

On average, the development of a single drug can cost a pharmaceutical company between US$800 million and US$1 billion and take eight to 16 years to research. Despite such a significant investment, success is never guaranteed. Failure means big losses. As we all look for innovation in our industry to save money and deliver quality, it’s extremely important to remain true to the basics. Going "low tech,” which really means just paying attention to the high-tech fundamentals, can be a big win for your organization.

Reading and safety

Don’t put off refresher training and updates. Yearly refresher training may seem redundant, but it serves a very important purpose: to ensure that all quality assurance managers, quality control managers, coordinators, etc., are on the same page when it comes to safety, conduct, and responsibility. This training keeps important topics fresh in your mind. Wearing proper protective equipment ensures that in the rare event of an accident you will be protected. Eyewear and other equipment are required and inexpensive, especially compared to loss of great work, loss of time, or failure of the products that are so important to us.

Writing

Revise and contribute to your process “notebook” not in an abbreviated way but with detail. Projects are revisited for details prior to rerunning the experiment or validation or comparison of one experiment to another. Always making complete entries helps you make sense of what you did in the past; “See network drive for data file” is great as long as you note which file it is.

“The control sample did not work” is ambiguous until you describe the type of control sample and the experimental conditions. Give yourself a helping hand and be thorough with everything you write in your laboratory notebook. Good laboratory practice (GLP) studies require adequate and permanent documentation of everything involved in an experimental test, from staff qualifications and SOPs to the individual summary of data.

Consistent records are a must, and at the end of a project your supervisor will want to review procedures and data from beginning to end. Just as in school, this is show-and-tell time for anything you’ve done in the lab, and one good rule to live by is “If it wasn’t written down, it probably didn’t happen.” While the regulations tell companies what they need to do and document, remember that they don’t tell us exactly how. Effectively prepared process documents keep companies on track and compliant.

It’s simple arithmetic—it really is all about the basics! Practice the habit of double- and triple-checking your work. Before mixing up that expensive batch of media, review units and calculations to see that your numbers make sense. Accuracy and precision in measurement analysis ensure appropriate conclusions in experimental results, including between and within laboratory variation results. This also means running control samples. Controls serve two very important purposes. They show whether your chemistry worked appropriately, and they serve as the basis by which you can make a definitive comparison between groups of samples. The cost of innovation in the life sciences has risen greatly over the past two decades.

Alternative models of development and testing will need to be embraced, requiring streamlining of regulatory and organizational approaches and necessitating precision in richness of the data collected. Things such as the Wii were innovative because they were less complex and easier to understand, and getting back to basics with a slight twist may be what keeps us competitive in the current business environment. Bill Gates said that the way to get innovation is to fund research and learn the basic facts. The new Rs in GLP have been said to be reliability, reproducibility, and recording of results. These foundational concepts to ensure success are always in practice when you are practicing the best lab practices you can.

Categories: Business Management

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5 Keys to Effective Communication

Published: December 1, 2012

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