Critical thinking in CSV,
think about it
As automation becomes the norm in the pharmaceutical industry, ensuring compliance and efficiency across the entire lifecycle of computerized systems is more crucial than ever. The updated GAMP 5 2nd Edition introduces critical thinking as a key approach to managing these systems effectively while maintaining patient safety and product quality.
Objective
PLCs and software have been integrated in all kind of equipment more and more in the past years. Equipment with automation is more common than non-automated equipment. In the pharmaceutical industry this impacts all the equipment life cycle phases. From the conceptual phase up to far beyond the decommissioning phase automated systems should receive proper attention to be able to use the systems as required and within the compliance requirements. In 2022 the ISPE issued the second edition of the GAMP 5, a risk based approach to compliant GxP computerized systems. The second edition includes current technology (artificial intelligence (AI), machine learning (ML), and blockchain) and refine and strengthen key topics such as an improved link to patient safety, it brings more focus on process and product understanding, science-based quality risk management and leveraging supplier involvement. This improved content is defined as critical thinking.
Challenges and Approach
Critical thinking is a new section in the GAMP 5 2nd edition. It is a term which should be applied in a holistic manner to the entirety of the business process that the computerized system supports. By this overall approach it should avoid missing potential risks to patient safety, product quality and data integrity for complex and high impacting software packages. On the other hand this approach should also give the opportunity to implement the package effective without non value adding (documentation) activities. Knowing only specific parts of the software or using quality risk control methods incorrect will increase the risk on misinterpretation or missing critical items. This can impact the product quality or patient safety or will lead to insufficient working flows.
For instance, by using the supplier’s knowledge not in full potential, or have no knowledge about the origin of the software modules, will increase the risk on quality issues at a later stage. The use of critical thinking for the supplier selection and supplier performance standard will help to decrease the risks in choosing the incorrect supplier.
Execution
Adapting critical thinking during the quality risk management process should be based on the systems specification related to the production process that the system is supporting. Critical thinking should result in making the correct choice for a detailed assessment on specific functions when the overall risk is too high or choosing to not step into the details if the overall risk is too high, but the functions will not impact patient safety, product quality and or data integrity.
During the operational phase computerized systems will be subjected to ongoing changes. Changes are not only applicable to the GxP systems but also the supporting systems should be maintained and supported to control patient safety, product quality or data integrity. Critical thinking can be used to embrace the software improvements by efficient change management instead of collection changes with the goal to limit the software changes due to the amount of related work. When systems failures are discovered during the operational phase critical thinking can be used to root-cause analysis. By developing effective test metrics containing risk level of functions should lead to a robust and effective root-cause analysis and corrective action plan.
Conclusion
To adapt critical thinking the most important is to have detailed knowledge about the production process and the interaction of the computerized system with it. Secondly a detailed knowledge of the computerized system will help focusing on the correct parts of it. On top of it the complete organization should be ready for the more flexible options that might be used as part of the outcome of critical thinking. By using critical thinking throughout the full life cycle of computerized systems the control on these systems will be increased and the efforts for using computerized systems will be decreased. This all will result in a higher control of the production process with less unforeseen inactions.
Besides all these benefits critical thinking is also fun to do. It will give a positive boost to know how the software is working and how it interacts with the production process. It can give energy to be able to focus on the essential parts of the qualification and validation activities and skip all the non-impacting details. This is why I believe: Critical thinking: think about it!
Let's get started
If you want to adapt Critical Thinking or the updated scope of the GAMP 2nd edition into your computerized system quality management Progress – Experts in Life Sciences can assist you in these steps. Progress consultants have detailed knowledge about the related guidance’s and regulations and have the knowledge and insights to adapt these into your computerized system validation approach. Besides this the Progress colleagues are hands on, don’t get lost into paper based exercises and are nice to work with. Please contact the Progress – Experts in Life Sciences office via the contact details below, when you want to have more information about this topic.
