GAMP Categories for Computerized Systems

GAMP Categories for Computerized Systems | QbD Group

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New to validating computerized systems? If so, it might be difficult to get started on this type of validation. Why? Because, even if you have experience in another area of validation, you will have to deal with new, unfamiliar terms. After all, it’s a very technology-related topic. In this article, you will learn what GAMP is, what GAMP categories are for, and where to start if you are facing computerized systems validation.

Curious? Be sure to read on!

What is GAMP?

In a nutshell, GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.

What are GAMP 5 categories for?

GAMP categories are mainly used to subdivide computerized systems according to their complexity. In this way, the validation strategy can be focused on the points where the system is riskier.

The more complex a system is, the greater its risks will be. These risks primarily involve data integrity, product quality, and patient safety.

GAMP 5 software categories with examples

There are 4 categories in which GAMP 5 groups computerized systems according to their complexity. These categories define the approach to full validation. In other words, they determine:

the validation route to follow
and the necessary documents to demonstrate that your system is suitable for the use that will be given and complies with the GxP regulation.

The GAMP categories described are summarized below:

GAMP Category 1: Infrastructure

Infrastructure: platforms on which computer applications or elements are necessary to operate and manage information technology environments run.

Examples: operating systems, firewall, antivirus.

GAMP Category 3: Non-configurable software

Non-configurable software: software without configurable functions, they are marketed freely or are integrated into hardware to allow their operation.

Examples: tools for statistical calculation, software for data acquisition without configuration capacity, control panel viewers, spreadsheets used as databases or as documents without some level of configuration.

GAMP Category 4: Configurable software

Custom or bespoke software: They are those that are tailored to meet specific needs of the organization that optimize its processes.

Example: ERP (Enterprise Resource Planning), LIMS, Spreadsheet applications with formulas and / or input data linked to specific cells, production equipment control systems associated with the process (eg PLCs).

GAMP Category 5: Custom or bespoke software

Custom or bespoke software: They are those that are tailored to meet specific needs of the organization that optimize its processes.

Example: Examples include software add-ons for categories 3 and 4, spreadsheets with VBA scripts, unique and dedicated systems, ERP systems or developments of these made to meet the specific needs for an organization or a specific business, among others.

What is considered a configuration?

The configuration of a computerized system refers to the values that are assigned to a certain variable of specific software, which do not imply changes or modifications of the original functionalities, but rather indicate how the system should work to adapt to the needs of the users in the context of their processes.

Why is there no GAMP category 2?

GAMP category 2 is currently in disuse because, when the categories were defined in version 4 of GAMP, firmware had its own characteristics that differed from the rest of the categories.

Nowadays, firmware has evolved to the point the majority is counted as category 3, 4, or 5. So, when GAMP 4 transitioned to GAMP 5, category 2 was removed but the numbering was not changed, leaving only categories 1, 3, 4, and 5.

Conclusion

GAMP categories are useful for classifying systems according to their level of complexity to determine a validation strategy that can meet the requirements, but more importantly, to focus on the issues that pose a significant risk to the functionality of the systems.

New in systems validation and need help with kick-off? Our experts are happy to assist you with the best validation program according to your available resources.