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Overview of GAMP 5 2nd Edition 

GAMP 5 2nd Edition is based on one key goal: 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.” The main issues highlighted in GAMP 5 2nd edition surround innovation, critical thinking, agile methodologies, and IT service management. The guidance shows a clear evolution from Computer Systems Validation (CSV) to Computer Software Assurance (CSA).

What is GAMP 5   

It's the ISPE's best practice guidance which has been accepted by regulators worldwide (including the FDA) and is widely referenced in their literature and documentation.  A cost effective framework to ensure that computerised systems are fit for use and compliant with regulation.
GAMP 5 ® sets out guidelines for systems’ validation governed by five key concepts rooted in risk-based thinking.
    

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    Risk Management

    GAMP 5 emphasizes a science based risk management approach to system validation and qualification. It encourages organizations to identify and assess potential risks associated with automated systems, allowing them to effectively allocate resources and prioritize validation activities.

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    Lifecycle Approach

    The framework promotes a lifecycle approach to system development and maintenance. It recognizes that systems evolve over time and advocates for validation activities to be conducted throughout the system’s lifecycle, from concept to retirement.

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    Supplier and Internal Audits

    GAMP 5 emphasizes the importance of auditing suppliers and internal processes to ensure compliance and quality. Regular audits help identify gaps and areas for improvement in system development, implementation, and maintenance.

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    Documentation and Traceability

    The guidelines stress the need for comprehensive documentation and traceability throughout the system’s lifecycle. Detailed records enable transparency, facilitate audits, and demonstrate compliance with regulatory requirements.

  • BPTC epertise in Clinical and Commercial MAnufactuing  for Bio tech
    Change Management

    GAMP 5 encourages organisations to have change management processes and robust procedures in place. Evaluating and controlling changes to automated systems helps to ensure that changes do not compromise product quality or patient safety.

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Revised GAMP 5 V-Model 

In the early 1990s, the GAMP guide was mainly used to control suppliers of manufacturing production equipment to the pharmaceutical industry. Thus, the V model was used in the first four versions of the GAMP guide from 1994 to 2008. This V model worked very well for manufacturing equipment and equipment with computer control elements with simple configuration. But there are better-suited alternatives now.

With the recognition of agile methodology in GAMP 2nd Edition as a non-linear approach for software development and validation, legacy validation documents from GAMP 1st Edition, such as installation (IQ), operation (OQ), and performance qualification (PQ) documents, are no longer relevant. 

GAMP 5 revised V model

 

 

Benefits of GAMP 5

Adhering to GAMP 5 guidelines offers several benefits to organisations:

Regulatory Compliance: GAMP 5 aligns with regulatory expectations and helps organisations demonstrate compliance with various regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Quality and Data Integrity: GAMP 5 ensures that automated systems consistently produce high-quality products while maintaining data integrity, fostering patient safety and trust in the industry.

Risk Mitigation: By adopting a risk-based approach, GAMP 5 helps organizations identify and mitigate potential risks associated with automated systems, minimizing the likelihood of product recalls, safety issues, and regulatory penalties.

Improved Efficiency: The lifecycle approach and emphasis on change management in GAMP 5 lead to more efficient system development, implementation, and maintenance. This results in reduced downtime, enhanced productivity, and decreased costs.

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A good Quality Management System underpinned by robust document control functionality - can help companies create and document these risk -based software validation processes, so that they are streamlined and auditable at the touch of a button. 

Summary

GAMP 5 outlines a risk based approach to Compliant GxP Computerised systems that can help manufacturers streamline their processes even as their regulatory obligations increase and supply chains become more complex.


Contact 

Bio Pharma Technical Consulting  
Cork, T23 KW81, Ireland
contact@bptc.ie  

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   Rau Consulting LLC 
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