ISPE GAMP5

GAMP 5 was released in 2008 detailing “Risk Based Approach to Compliant GxP Computerised Systems” with the tag line “Enabling Innovation” and was hailed as a major advancement in the industry.

This article provides a short review of the GAMP guide and the benefits to the industry.

ASTM Standard

The publishing of the ASTM Standard E2500-07 in June 2007 set the scene for changes within the quality systems of pharmaceutical industry.

Not only did this standard use different terminology, verification rather than validation and qualification it adopted a risk based approach throughout the process claiming

• This guide describes a risk-based and science-based approach to the specification, design, and verification of manufacturing systems and equipment that have the potential to affect product quality and patient safety.
• This guide describes a systematic, efficient, and effective way of ensuring that manufacturing systems and equipment are fit for intended use, and that risk to product quality, and consequently to patient safety, are effectively managed to the extent that these are affected by such systems and equipment.

The industry was quick to embrace the sentiments expressed by the standard and the ISPE started work to align the standard with their guideline documents (Baseline Guide and GAMP 5).

While the ASTM standard places great emphasis on the use of Good Engineering Practices (GEP) the standard lacks detail on the practices required for Computerised Systems. The issue of GAMP 5 provides a framework that that incorporates Good Practices into the Design, Specification, Verification and Maintenance of the Compliance state.

Major Changes

At first glance the changes to GAMP 5 from GAMP 4 seem minor and a natural progression. Yes the terms are aligned with the ASTM Standard and Risk Management is placed through the lifecycle.

The lifecycle approach is not changed significantly from GAMP 4, with the V Model simplified. In GAMP 4 each specification was aligned to a testing phase, Hardware Specification to Installation Qualification, Functional Specifications to Operational Qualification, etc while in GAMP 5 Specification is aligned to Verification.

The GAMP 4 V-Model was pretty unworkable and assumed that only the User Requirements Specification defined performance characteristics. The traceability of Requirement to Design and Testing through the Requirements Traceability Matrix (RTM) provided a more linear approach to ensuring that requirements were met by the design and tested during qualification.

The simplified approach of specification to verification in GAMP 5 supports this approach.

GAMP Categories

The GAMP categories have been revised in GAMP 5 and Category 2 firmware has been removed.

Personally I believe that this is to one dimensional and while it worked GAMP 3 to support qualification process and in a degree GAMP 4. The categories do not take in to account the criticality of the equipment or the emphasis that is placed on the supplier. A critical system with supplier testing may need a higher level of governance from the pharmaceutical company than a similar system in a less critical area of operation.

This would be better suited during the initial risk assessment and I will come back to this subject at a later date.

Risk Assessment Process

The risk assessment approach was included within GAMP 4 (Appendix M3). The guideline described a simple risk assessment process that may be applied to automated systems to enable the targeting of validation effort to those areas and functions that most require it.

Within GAMP 5 this process has been greatly expanded and the Science and Risk Based approach provides a common thread through the validation lifecycle.

I will post further articles on the risk assessment processes and methods that can be employed at a later date.

Summary

Rather than a revolutionary step the issue of GAMP 5 takes an evolutionary progression. The alignment with ASTM E2500-07 and the emphasis on the Risk Management process throughout the lifecycle make the evolutionary progression significant and when established within a business provide a cost effective measures for implementing systems within the pharmaceutical industry.

Development of Good Practices in Engineering and IT are critical to ensuring that a risk based approach with the validation effort concentrated only on the quality critical attributes that the business and safety risks that had fallen under validation as the test department do not get missed.

Again a discussion for another day.