GAMP 5 – The risk-based approach validation of GxP computerized systems

GAMP 5, the latest guideline issued in February 2018 by the ISPE (International Society for Pharmaceutical Engineering) represents the most recent and updated tool in the approach for the validation of GxP computer systems. The guideline aims to “provide a framework of cost-effective best practices to ensure that computer systems are suitable for use and compliant with the legislation”.

The guideline has been designed in such a way as to be compatible with IEEE, ISO 9001 and 12207, ITIL and other international Standards. In addition, the working group that was involved in the drafting of GAMP 5 also aimed to:

  • Focus on those computer systems with most impact on patient safety, product quality and data integrity;
  • Leverage as much as possible suppliers’ activities, while ensuring the suitability for the intended use;
  • Recognize that most computer systems are now based on configurable packages.

GAMP 5 key concepts

  1. The product and process comprehension, essential to determine system requirements and to make decisions based on risk assessment, to ensure that the system is “suitable for use”. More specifically, when determining this suitability, attention should be focused on “those aspects crucial to patient safety, product quality and data integrity”.
  2. The life cycle approach within the Quality Management System (QMS), including all stages and activities from conception and implementation to full operation and software retirement from the market.
  3. The scalability of life cycle-related activities, through a “V” model, which can be extended or even reduced depending on the scale or scope of the system that is being validated. The GAMP 5 guideline provides three practical examples of the “V” model.
  4. The scientific approach to risk management, this allows companies to focus on critical aspects of the information system and to develop controls to mitigate these risks. This is where a clear comprehension of the product and the process is crucial to determine the potential risks to patient safety, product quality and data integrity.
  5. Leverage the involvement of the supplier, more specifically in assisting the manufacturer with activities such as: maintenance, testing and technical support, collection of requirements and configuration of the information system.

The supplier evaluation approach for computerized systems

The manufacturer is responsible for the documentation, approval and compliance of each element of the computerized system lifecycle. When suppliers are progressively more involved in the lifecycle of their products, manufacturers must assess that the supplier has processes in place to ensure product quality. In order to help suppliers meet their customers’ needs, a section dedicated to suppliers’ activities was included in GAMP 5.

The contract between manufacturer and supplier (the QTA, or the Quality Technical Agreement) is a critical aspect when outsourcing. It also implies an assessment of the risks incurred before signing the contract. This evaluation consists in a verification/due diligence of the most critical cases (for example, outsourcing of infrastructures).

It can be concluded that the production systems for the pharmaceutical and food industry must comply with increasingly stringent legislation, which also includes the requirements of the European Medicines Agency (EMA) and the Food & Drug Administration (FDA). Although GAMP 5 is not a legislation, it is still a reference guideline for companies involved in the development and/or implementation of automated production systems.

In order to guarantee the required quality, manufacturers operating in the aforementioned regulated sectors must be able to interpret and apply correctly the GAMP 5 guidelines. Please bear in mind that GAMP 5 is not “a prescription method or standard, but rather provides pragmatic indications, practical aspects and tools for professionals of the sector.” Therefore, manufacturers should use these guidelines along with industry Standards and other Good Practices to determine the best approach for validating GxP computerized systems.

In return, the correct application of GAMP 5 will allow manufacturers not only to reduce the time and costs necessary for the validation and the maintenance of their (compliant) systems, but also to overcome government audits and inspections more easily.

 

THEMA - Logo TRASPARENTE_smallIng. Enrico Centin
Product Manager – QA/RA Consultant

 

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