Of all the significant chapters in my scientific journey so far, making the move away from a highly reputable academic research lab, to a stringent Quality Control (QC) Good Manufacturing Practices (GMP) global pharmaceutical company environment, has undoubtedly been the most challenging.
Moving between these two unique environments has of course presented the inevitable obstacles, frustrations and turbulence that comes with a radical career change, but looking back and with the benefit of hindsight, I honestly feel my move could have been so much smoother, had I done so with a firmer grasp of the rationale for, and the implementation of, various GMP principles.
Through the lens of my work today at Thermo Fisher Scientific, my intention in writing this blog is to give you a glimpse into what I went through, and also to offer you some good advice. So, I want to share what I consider to be some invaluable top-tips, which I hope also helps make for a less taxing and more seamless transition, should you ever make a similar career move.
Tip 1: Achieving the highest level of uniformity among common lab practices is an absolute must
Pipetting training is pretty much mandatory for everybody joining the QC GMP lab, even if, like me, you join with extensive previous experience in academic research. There is no place for importing personal habits when performing even simple tasks into the QC GMP environment. It’s clear to me now the reason for this training: it’s to minimise or even eradicate any inherent bad pipetting habits.
Defined standards for performing any tasks in GMP has the ability to reduce the variability and increase the reproducibility of the results. Uniformity among common lab practices can consequently contribute to a reduction in the number of deviations in the GMP lab and reduction of time spent on quality control activities.
Pipetting can be very tricky in busy labs, as hundreds of repetitive assays need to be performed every day, and despite the intensive training provided, we still saw a lot of variety due to inaccurate pipetting. Thermo Scientific™ E1-ClipTip™ Electronic Single Channel and Multichannel Pipettes are the perfect solution for QC GMP labs. This product helps simplify repetitive pipetting tasks, and with the ‘My Pipette Creator’ app you can take advantage of efficient, centralised programming and sharing of protocols between pipettes and your colleagues.
Tip 2: Recording activities in accordance with Good Documentation Practice (GDP) and QC is probably the most important, time-consuming priority
GDP rules are very tough to master. There is a seemingly an endless number of controlled documents, including Standard Operating Procedures (SOPs), which all require a regular updates and QC. In academic research, the lab book is used to record daily activities, though in my experience, this is never really governed by strict rules. In stark contrast, any efforts to lodge records in the academic lab book, is incomparable with the meticulous requirements for documenting activities in the QC GMP lab, where this action is considered supremely important.
All activities need to be recorded with great precision and at the time of individual tasks being performed. This may seem pedantic but even includes using a permanent marker pen and following strict rules for correcting mistakes when entering a record. Even simple calculations need to be QC checked before you can progress with your assay to the next step. Each consumable, reagent, pipette, or any other piece of equipment used, needs to be recorded in minute detail, including lot numbers, expiry dates, calibration statuses, etc. All with the express aim of tracing every possible mistake, that may contribute to deviation, or even result in low-quality data or product.
With no controlled documentation in place, traceability would be not possible and therefore a quality management system (QMS) could not be implemented, and consequently patient safety could be compromised. The documentation associated with every piece of equipment coming into the GMP-ruled environment has an enormous impact on how efficient and compliant the facility can become in terms of daily operations, as well as how fast the new QC GMP lab can pass regulatory audits.
Thermo Fisher Scientific recognises the need for extensive factory acceptance certification—for example, on-site compliance support, step-by-step procedures, or even compatibility with new stringent cleaning procedures—all to make the validation process speedy, super-efficient, audit-proof and furthermore make daily operations as smooth and error-free as possible in the long run.
Thermo Scientific™ Cell Therapy Systems (CTS) Series laboratory equipment is enhanced with compliance, support and field services, from CO2 incubators and centrifuges to cold storage, biological safety cabinets, and beyond. See our website for more information.
Tip 3. Contamination prevention and cleaning are critical
Across the scientific community, I think we can all agree that events caused by contamination in the academic research lab environment, can be both frustrating and devastating. I have experienced contaminations myself when cultivating primary cells. I have lost many precious experiments, exhausted time and important research grant money. However, the effects of the same contamination event in the QC GMP lab, or a GMP cleanroom production facility, can often be much more devastating. For example, a patient’s life can directly depend on a final cell therapy product. Or a QC GMP lab performing very costly batch release testing for example, can risk harming the company’s reputation and losing future business.
Therefore, the majority of GMP key principles revolve around contamination prevention and rigorous cleaning. To prevent contaminations from occurring, GMP compliant institutions invest a lot of monetary resources and time in structured training, facility design, quality management systems, equipment maintenance and monitoring, as well as following complex standard operating procedures (SOPs) designated to different types of cleaning. The extensive experience I have gained while in the QC GMP lab, has certainly taught me a very important lesson: when procuring lab equipment, it’s important to seek equipment that contains advanced and scientifically proven contamination prevention features. To me, that’s the only way forward, and why I believe Thermo Fisher Scientific does not disappoint in this regard.
As a leading provisioner of scientific instrumentation, (as well as reagents, consumables, software and services), Thermo Fisher Scientific places considerable effort into developing and perfecting contamination prevention features within its lab equipment portfolio. Extensive step-by-step procedures are always provided with our lab equipment, which can be easily transferred into the SOPs templates. What is particularly noteworthy, is Thermo Fisher Scientific sets itself apart from other instrument manufacturers on the market, because the company always follows current regulations, performs and invests in extensive third-party testing, to ensure the contamination prevention features on its lab equipment are effective.
Contamination prevention is especially critical in GMP cleanroom facilities dedicated to cell therapy production. The final product in the form of living cells has inherent limitation for the final purification and sterilisation, therefore microbiological, as well as physical particle related contaminations, can have a devastating consequence.
At the heart of cell therapy production are CO2 incubators and the first to market Thermo Scientific™ Heracell™ Vios CR CO2 Incubator has independent TÜV SÜD certification for compatibility with ISO Class 5 and GMP grade A/B cleanroom environments.
This incubator is designed to actively control particle emission, allowing scientists to confidently plan their cleanrooms to meet strict air quality requirements, while continuing to offer the best high performance and cell growth conditions. This is due to the incubator having a robust stainless-steel exterior and IP54-compliant design. This means that the Heracell Vios CR CO2 incubator can withstand even the most rigorous and repeated cleanroom cleaning procedures. It also comes with a range of cleanroom-compatible accessory options, including stacking adapters and roller bases, as well as a comprehensive cGMP documentation package to support time-efficient validation process.
Any transition from academic research into the biopharma world, tightly administered by good practices, can be a very demanding, at whichever point in your scientific career you might find yourself making this move, (or even if you find yourself starting a new cGMP compliant company).
There are many ways to comply, as GMP is not necessarily a set of definite rules, but rather a guidance. This can make a transition even more complex, as your unique lab procedures can make implementation of cGMP distinctive.
Through this course, I believe the most crucial thing is to have an experienced partner with you: somebody you can always rely on in every step of the transition process.
With an extensive understanding of the unique challenges associated with adaptation to GMP systems, and a pragmatic knowledge of the appropriate instrumentation solutions, Thermo Fisher Scientific really can help you to concentrate more on achieving your scientific goals and less on feeling stressed or frustrated as you adapt to a new reality.