Senior Research Scientist Bryna Harris, has multiple years worth of experience purifying and analyzing a range of different compound classes. In our lastest blog she goes into detail how she implemented these experiences to improve processes at Charnwood Molecular.
In the world of GMP labs, you won't find any Post-it notes sticking around!
I am thrilled to share with you my extraordinary journey of growth and adaptation as I ventured from the highly regulated world of a GMP pharmaceutical company to the dynamic and innovative landscape of a non-GMP discovery company. Having spent considerable time in the rigorous realm of Good Manufacturing Practices (GMP), where precision and compliance were the backbone of daily operations, transitioning to a non-GMP setting opened up a realm of possibilities, creativity, and innovation that I had never experienced before. While the regulated environment served as an invaluable foundation for my career, the shift allowed me to explore new horizons and uncover novel ways of achieving excellence. I will delve into the challenges and triumphs of integrating GMP principles into a non-GMP lab environment, shedding light on the valuable insights I’ve gained along the way.
While it is undeniable that certain GMP practices can be perceived as tedious and excessive, there exists a wealth of valuable principles that can and should be transferred to non-GMP environments. As someone who has experienced both worlds, I’ve come to appreciate the benefits of certain GMP practices, such as appropriate documentation, quality control measures, and standardised procedures. While I truly valued the importance of GMP working, I have to admit that the constant ‘cross-through, sign, and date’ was a bit monotonous for my liking, but maybe I just needed to make fewer typos! Embracing the relevant aspects of GMP in non-GMP settings can lead to enhanced efficiency, improved reliability, and elevated standards of excellence, ultimately driving innovation and success in the pharmaceutical landscape.
Documentation
Documentation is a cornerstone of GMP practices that holds immense value in any regulated environment. While it may seem burdensome to maintain extensive records and documentation, its significance cannot be overstated. Detailed documentation plays a pivotal role in ensuring traceability, accountability, and transparency throughout a product’s manufacture.
In a GMP pharmaceutical company, meticulous documentation is essential to demonstrate compliance with regulatory requirements. Batch records, standard operating procedures (SOPs), and validation protocols provide a clear and comprehensive account of every step involved in the manufacturing process. This level of documentation not only satisfies regulatory agencies but also serves as a reliable reference for internal audits and continuous improvement initiatives.
When transitioning to a non-GMP lab environment, some might perceive a reduction in the need for extensive documentation. However, overlooking the value of well-maintained records can be a missed opportunity. Even in non-GMP settings, proper documentation remains a key element in fostering efficiency, consistency, and reproducibility.
Beyond the confines of the laboratory, documentation also aids in protecting intellectual property and meeting compliance requirements. Well-documented research and development activities provide evidence of ownership, which is crucial for patents and protecting proprietary knowledge. In conclusion, while some may view documentation as cumbersome, its benefits extend far beyond regulatory compliance. By embracing and integrating the essential documentation practices from the GMP world into non-GMP labs, organisations can harness the power of structured information to drive success and excellence in pharmaceutical research and development.
Quality Control Measures
Quality control measures are fundamental to GMP practices and play a crucial role in safeguarding the integrity and safety of pharmaceutical products. These measures encompass a series of systematic and comprehensive checks, tests, and evaluations that occur at various stages of the production process, from raw material procurement to the final product release. When transferring these measures to a non-GMP environment, it becomes evident that they contribute significantly to ensuring consistent, high-quality outcomes.
In the pharmaceutical industry, final product quality relies heavily on analytical testing and release procedures. In GMP settings, products are subjected to extensive testing to verify their identity, potency, purity, and other critical characteristics. This helps prevent the release of defective or non-compliant products into the market. In non-GMP labs, adopting quality control measures can enhance the credibility and reproducibility of products. Clients can have increased confidence in the results when they know that robust quality control measures were followed during experimentation.
Furthermore, adopting quality control measures in non-GMP environments can facilitate technology transfer and collaboration between organisations. When processes are well-documented and quality controlled, it becomes easier to share methodologies, data, and findings with clients.
Overall, quality control measures from GMP practices serve as a powerful framework for maintaining consistency, reliability, and credibility in both regulated and non-regulated settings. Integrating these measures into non-GMP laboratories not only enhances research outcomes but also promotes collaboration, credibility, and adherence to rigorous scientific standards. By upholding the principles of quality control, even in non-GMP environments, we foster a culture of excellence that drives continuous improvement and innovation in pharmaceutical research.
Standardised Procedures
Standardised procedures are essential components of GMP practices that establish clear, uniform guidelines for various processes within a pharmaceutical company. These procedures define specific steps to be followed during manufacturing, testing, and other critical activities, ensuring consistency, efficiency, and regulatory compliance. When transferred to a non-GMP lab environment, standardised procedures bring structure and reliability to experimental processes, enabling scientists to achieve more robust and reproducible results.
In a GMP pharmaceutical company, standardised procedures are meticulously developed and thoroughly validated. These procedures cover a wide range of activities, including manufacturing operations, cleaning protocols, equipment calibrations, and analytical testing. Adhering to these standardised processes is critical in maintaining product quality and safety, as well as complying with regulatory requirements.
In non-GMP labs, the application of standardised procedures can streamline technology transfer and facilitate training for new team members. Scientists can quickly adapt to new projects and methods when standard operating procedures (SOPs) are readily available. This adaptability and consistency ensures that projects proceed smoothly and that data generated is of high quality.
To ensure the success of standardised procedures in a non-GMP environment, it is essential to establish a culture of continuous improvement and feedback. Scientists should have the opportunity to provide input on the procedures, suggest improvements, and collaborate in refining the methodologies. In summary, standardised procedures are not only beneficial in GMP pharmaceutical companies but also play a vital role in non-GMP lab environments. By adopting standardised processes, scientists can enhance the consistency, reliability, and efficiency of their work, leading to more credible and impactful research outcomes. The implementation of standardised procedures nurtures a culture of excellence, collaboration, and continuous improvement, driving innovation and advancement in the field of pharmaceutical research.
As I bring this post to a close, I am filled with gratitude for the experiences that have shaped my journey from a GMP company to a non-GMP discovery company. The integration of GMP principles into a more flexible lab environment has proven to be a catalyst for personal and professional growth, pushing me to embrace change and explore new opportunities. This journey has shown me the importance of blending the best practices from different worlds. I hope that by sharing my experiences in this post, I have provided valuable insights and inspiration to fellow scientists and industry professionals.
A Bit About the Author:
Bryna has previous experience in a GMP environment from working at Aptuit, an Evotec company. As a senior member of the team, she was responsible for the management of analytical methods development for new API programme, using a range of analytical techniques such as HPLC, GC, LCMS, GCMS, KF and optical rotation to fully support developing processes. Within the role she was responsible for the writing and reviewing of high-quality analytical methods and the examining of complex data analysis to ensure MHRA/FDA/ICH standards for GMP analysis were met.
Outside the lab Bryna is a keen seamstress making all her own clothes. You can connect with Bryna via LinkedIn.
