Overcome Challenges When Transitioning into a GMP Environment

Transitioning advanced therapy medicinal products from the research and development phase to production presents complex challenges. A critical aspect that significantly influences the process is managing GMP and cleanroom production compliance. Insufficient understanding of these compliance requirements often leads to delays and unexpected expenses. However, by carefully considering equipment needs, many common pitfalls can be avoided.

By familiarizing yourself with regulations and ensuring you have a full scope of potential future challenges, your lab can transition more efficiently. Compliance should be a top priority to maintain the safety and quality of therapy products. Understanding the requirements specific to your situation is an initial step but ensuring proper and correct documentation throughout the process – even as early as when you choose your equipment – is essential for continued success and an efficient transition.

When selecting equipment, consider factors such as ease of use, reliability, and maintenance requirements. Well-designed equipment can enhance process efficiency and product quality and may come with independent testing and documentation that may help with compliance validation. Consider what specific capabilities are required to fulfill your processes and ensure that the equipment aligns with your production goals and facilities. This evaluation should include factors such as scalability, automation, and compatibility with cleanroom requirements. Lab equipment plays a pivotal role in preventing contamination and ensuring the safety of therapy products. Selecting the right equipment can help establish an effective contamination prevention strategy by minimizing the risk of unwanted particulates that may compromising product quality. Additionally, equipment design plays a significant role in achieving consistent performance and reproducible results.  By understanding the compliance framework, considering contamination prevention strategies, evaluating equipment, and maintaining proper documentation, you can streamline the transition process and ensure the safety and quality of your advanced therapy products. Watch the on-demand webinar “Overcome challenges to succeed when transitioning into a cGMP environment” to learn how your supplier can provide valuable insights and guidance in implementing lab equipment effectively within a GMP and cleanroom environment.

Discover the numerous essential functionalities offered by Thermo Scientific’s laboratory equipment, in the brochures “Setting up a cell therapy production facility” and “Gene Therapy from set up to scale up” to learn how Thermo Fisher Scientific can provide cutting-edge, scalable solutions at any phase of the therapeutic production process.

Watch now: Overcoming challenges to succeed when transitioning into a cGMP environment (insights.bio)

For Laboratory Use. It is the customer’s responsibility to ensure that the performance of the product is suitable for customers’ specific use or application.