What you should Know About GAMP

We are well aware that healthcare industry is one of the most crucial industrial sectors in the world. With the advancement of technology and innovation, most of process are transformed to computerized systems. Since the industry follows strict adherence to their guidelines & code of conducts while operating these computerized systems, Adhering to these guidelines allows them to minimize the probability of deviation of operations or recorded data, which might cause bugs and errors that will have a vast impact on their final product or data.

With the gradual increase of these Systems, many manufacturing companies took this as an advantage to dwell into the field of pharma manufacturing. As a result, a need raised to come up with a foolproof and risk-free system.

Many standards Guidelines were developed like Annex 11, 21CFR Part11 Compliance, etc were developed so that these industries before  providing clearance to the vendors for the commissioning the system   

But many cases, situation system errors, failed audits and bugs which resulted a major downfall of quality checking and computer software validation

What is GAMP

The health care professionals came up with GAMP which stands for Good Automated Manufacturing Practice, which was officially released on 2008 which was an updated version for all the guideline versions which were mentioned above. These are a collective guidelines & standards designed to aid the system to operate automatically (automation) which gives the developer to design the system accordingly before been handover to a pharma company.

If we look into the GAMP 5, it is considered as a risk-based approach to computer system validation. Which allows the system executed & assigned to a predefined category based on its use and complexity

Rather testing the quality control batches GAMP allows quality testing as an important part of each stages of manufacturing. This takes a closer look into the installation, resources, equipment & staff hygiene. This set of strict code of conduct in Standard of Operating Procedures (SOP) helps assure the modesty of manufactured pharmaceuticals.

GAMP® 5 VS OTHER VERSIONS

If we look into the comparison between the GAMP® 5 and other versions is that the major difference is that GAMP® 5 is not a regulation whereas it is a set of guidelines followed by vendors & Pharma companies when validating a system.

The areas that GAMP publications excels are calibration management, Compliance infrastructure, data archiving & process validation. Which make GAMP the most guidance document, which is also referred as GAMP 5 as it focuses a detailed outline for the risk management principles & tools for computerized validation system

Since then professionals in the health & life sciences are using GAMP® 5 as a structured framework for complaint GxP computerized system in 2008. This led to the innovation in use of emerging technologies as ISPE was recognized it as GAMP® 5 (First edition)

The cause for the change

With the advancement & innovation towards computerized system at pharma manufacturing and validation. GAMP® 5 (first Edition) needed some amendments to carter specific areas which mainly focused on adding guidelines for trending topics. This led to the second edition of GAMP® 5.

The second edition mainly focuses on patient safety & product quality over compliance, which give more prioritizes in encouraging the critical thinking. This edition strongly supports the vision of FDA CDER which produces high quality drug products without extensive regulatory oversight. Which the CGMP minimum standards needs to be met accordingly to the robust quality management system

Also, the New version is developing its guidelines on the application of new & developing technological areas to be excelled such as Ai (Artificial Intelligence) Machine learning and even the latest hot pick which is blockchain. These CSA (computerized system assurance) is related US FDA CDHR cases for Quality program are also explored & applied

Conclusion

GAMP was introduced in 1991 in the United Kingdom to address the pharmaceutical industry desire to create guidelines that world could improve understanding of the change in expectations of the regulatory agencies in Europe. This included working with agencies in other countries like the US Food & Drug Administration (FDA) to builds up a strong relationship. It also encourages the understanding that we should have behind the computerized system validation been handled in a Pharmaceutical industry.

As a result both the edition of GAMP® 5 guidelines are recognized among the health and Science industries in brining out quality products to the market and to their consumers. This is why standard Organization has become a recognized guide for Good Practice worldwide

Do you want to understand more about GAMP® 5? Join us at the GAMP® 5 - US edition Masterclass on 21 & 22 November, 2022. 

By Nafhan Naseem, Jr. Social Media Executive & IT Support, GLC Europe, Colombo Office, Sri Lanka.