Implementing GAMP 5
28. February 2023
As any company in the life sciences industries will discover soon enough: Achieving compliance with GAMP 5 is a significant undertaking, especially for small and mid-sized businesses. However, despite these difficulties, it also brings numerous advantages. Let‘s discuss!
If you want to implement GAMP 5 in a smart way, you need a proper baseline.
First of all, you need a Computer System Validation (CSV) Policy or a Validation Master Plan (VMP), outlining the guiding principles, processes, and roles involved in validating your systems. The CSV Policy must be aligned with pertinent laws and regulations, such as US FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485. GAMP 5 good practices complete the legal requirements.
Additionally, you need an inventory of all systems in use: hardware, software, and data systems. This will allow you to provide an overview of which systems are GxP-relevant and need to be validated, as well as their current validation status.
To identify the validation need, you need to understand the initial or high-level software risks associated with a business process depending on its criticality regarding patient safety, product quality, data integrity (e.g., is the system used to control data for product release, to support pharmacovigilance or critical parameters in clinicals). This step aims to identify the GxP applicability of a system and its modules (whether or not it is regulated) and to classify its category (e.g., standard, configured, or self-developed). The outcome will subsequently contribute to the planning process. You can also include optional questions in the high-level risk assessment, for example, to cover aspects of data privacy or records management in only one assessment.
Now that you have set up the baseline, let‘s discuss the steps necessary to validate a system.
To implement GAMP 5 successfully, you need a Validation Plan that outlines your strategy, including the scope, validation strategy, and all activities required for validating the system. We recommend the following steps:
Naturally, the specific tasks involved in the validation process may vary, depending on the complexity and potential impact of the system that is verified.
Riad's consulting focus is on ensuring uniform PM standards for efficient collaboration, optimizing project execution, and supporting project management. In addition, he accompanies software validations.
Sandra's consulting focus is on the interpretating and risk-appropriately implementating regulatory requirements in processes and systems, coaching, and digital transformation projects in Compliance, Quality Management as well as Regulatory Affairs.