What is GAMP 5 Guideline? Checklist for GAMP 5 compliance
Alireza Zarei
CEO of Zamann Pharma Support and Pharmuni.com. Be the most constructive factor in a room.
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What is GAMP 5 Guideline ?
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.
GAMP 5 Guide, 2nd Edition , aims to continue to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality. GAMP is a risk-based framework for validating and controlling digital healthcare and pharmaceutical systems.
Whilie,?understanding what is GAMP 5 Guideline??It is important to note that rather than being a regulation, GAMP 5 is a set of principles and procedures created to help validate automated computer systems for manufactured pharmaceutical products. In other words, this guideline helps manufacturers meet regulations they must comply with to go to market. These best practices are respected and used by regulated companies and their suppliers all over the world. Lets understand GAMP 5 categories and checklist for GAMP 5 compliance in this article.?
Who does it apply to?
GAMP 5 targets to provide a explanation of how pharmaceutical/medtech companies should validate their computer systems. In practice, this means that these recommendations apply both to the users of automated pharmaceutical products, as well as the manufacturers who create and market them.
GAMP is not mandatory, nor is it a legally binding framework, but it remains the industry standard for validating automated systems. Developers in regulated industries typically use GAMP 5 to go to market with greater efficiency and less risk
Users should be aware of which assure computerized pharmaceutical products are appropriate for their intended purpose. For manufacturers, GAMP 5 guides them to ensure their products meet necessary regulatory standards according to a risk-based approach.
What are GAMP 5 software categories?
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. There is generally an increasing risk of failure or defects with the progression from standard software and hardware.
The more complex a system is, the greater its risks will be. These risks primarily involve data integrity, product quality, and patient safety.
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 description: Infrastructure software and tools.
Category 2 - Firmware (Removed)
GAMP category 3: non-configurable software
GAMP category 4: configurable software
GAMP category 5: custom or bespoke software
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Checklist for GAMP 5 compliance
Implementing GAMP 5 guidelines in software of different GAMP categories is a strategic process that requires meticulous planning, execution, and ongoing management to ensure compliance and enhance the quality and integrity of the data. ?Lets see practical, step-by-step approach to implementing GAMP 5 in LIMS software, ensuring your system is robust, reliable, and regulatory-compliant.
When implementing GAMP 5, you’ll need to consider your product and specific regulatory requirements for your industry. It’s also important to account for any cross-industry regulations that may apply. Use the following GAMP 5 compliance checklist to more closely align with the framework.
1. Understand GAMP 5 Categories and Classify Your software. e.g. LIMS
2. Conduct a Risk Assessment
3. Develop User Requirements Specifications (URS)
4. Select a Suitable Vendor and evaluate
5. Design and Development
6. Configure, Customize, and Develop the System
7. Validate the System
8. Implement Change Control and Configuration Management
9. Ensure Data Integrity and Security
10. Train Users and Develop SOPs
11. Perform Periodic Reviews and Revalidation
12. Maintenance and Support:
Conclusion:
GAMP categories streamline system validation by matching system complexity with an appropriate strategy, prioritizing the resolution of high-risk issues to ensure optimal functionality.
Implementing GAMP 5 standards not only minimizes process and product risks but also enhances market presence, customer satisfaction, and the likelihood of favorable FDA audits through diligent adherence.
The GAMP 5 Guide, 2nd Edition, goes beyond basic compliance by promoting up-to-date IT practices, comprehensive quality risk management (QRM), and superior software engineering to improve product quality and safety for patients and the general public.
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