GAMP5: another day, another acronym. So let’s break it down! GAMP5 stands for the Good Automated Manufacturing Practices 5th version. This publication is monitored by the GAMP committee of the International Society for Pharmaceutical Engineering (ISPE), who also publishes the GAMP guidelines.
GAMP5 outlines best practices for computerized system validation in the pharmaceutical industry; however, its framework is applicable in most industries. It is a pragmatic, structured, and risk-based approach to validation and implementation of a Real Time Monitoring System (RTMS) that brings together stakeholders to make decisions based on experience, knowledge, unique challenges faced by your facility, and other factors entirely unique to your organization.
The comprehensive approach taken by GAMP5 has numerous benefits, so let’s talk about a few of them!
Follows Annex 11 and 21CFR11 Regulations
GAMP5 outlines regulations set forth by ISPE. They are not regulations, so you do not have to follow them; however, their risk- and evidence-based framework to computerized system validation is largely accepted in the industry and falls in line with regulatory bodies. When GAMP was last updated in 2008, it was done in conjunction with regulatory agencies, such as the FDA, specifically to provide guidelines that reflected the changing nature of regulations and new requirements.
In Europe, Annex 11 outlines the regulations for computerized system validation. In the USA, we refer to 21 CFR 11. Both sets of regulations require a comprehensive and risk-based approach to validation, which falls directly in line with GAMP5’s framework.
Thus, following GAMP5 will help you implement an RTMS that is in line with regulations and makes audits easier.
Helps Determine Scope of Testing And Saves Time
When it comes to validating a complex system with dozens – if not hundreds or thousands – of working parts and components, it can be easy to lose time concentrating on low-risk areas. If you do not have a systematic approach to testing, this can happen quickly.
GAMP5’s risk-based approach helps you concentrate testing efforts on high-risk portions of your system. Its framework also helps you formulate your rationale for why these areas need more testing than others. Thus, your testing is customized, logical, pragmatic, and organized, making it more efficient and scalable as needed.
If there is one phrase that gets everyone involved in quality management and cleanrooms excited, it is “risk mitigation”. We love finding ways to reduce risk in a cleanroom and GAMP5 helps us do just that. Following traceable, scalable best practices for computerized system validation ensures your system is working properly and you have SOPs in place for system failure, contamination incidents, and more. A pragmatic and risk-based approach puts an emphasis on locations where trouble is most likely to arise, giving you confidence in your system.
Essentially, GAMP5 is a framework that helps you capitalize on your knowledge and requirements to create a powerful RTMS and set of SOPs based on your unique needs to reduce risk. It might seem daunting to undertake, but the systematic approach makes it simpler than you might think while giving you peace of mind through risk mitigation.
One aspect of computerized system validation is ensuring traceability, which is required to prove during audits. Creating a traceable system that has internal checks and balances goes a long way in making audits easier, giving you peace of mind, and improving your overall system flow.
ISPE Has A Plethora Of Resources
ISPE has made it very easy for those following GAMP5 to find information on computerized systems validation. They have published a number of reference materials, a series titled “Good Practice Guides”, for a variety of specific systems that have to be validated. Thus, you can likely find a guide specifically for the system you are using in your facility, specifically those using GxP systems.
Here at LWS, we love good resources. It is one of the reasons we built our comprehensive Knowledge Center compiling our 40+ years of experience as one of the world’s clean air experts into one spot for those looking to learn. It is also why we host monthly webinars with panel experts from all over the world. (Both our webinars and Knowledge Center are absolutely free, by the way.)
Having access to resources can make the difference between successful implementation and a disorganized mess. Thus, ISPE makes it easier for you!
Plan For The Future
Operating by GAMP5 guidelines should help you develop an agile and effective system for quality and risk management that is scalable. If you adhere to the guidelines today, you will benefit from the regulatory compliance, traceable systems, reduced risk, and more. By implementing this structure today, your organization will continue to benefit for years to come.
Working With a GAMP5 Oriented Vendor
When you are implementing GAMP5 in your organization, you will want to work with vendors who also follow GAMP5. For proper implementation of an RTMS according to GAMP5, your vendor will need to work with you to conduct a variety of functional tests.
Here at LWS, we take this approach very seriously. You need to be able to rely on your RTMS. It is a huge investment and you deserve the opportunity to customize it wherever possible to get the most out of your RTMS.
If you want to talk with one of our team members about what installing an RTMS with us looks like, contact us today.