The impact should be evaluated by using three different levels of critical state as criterion of assessment these are:

• • Direct Impact – A failure will have a direct impact on product quality
  • Indirect Impact – A failure will have an indirect impact on product quality
  • No Impact – A failure will have no impact on product quality

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Direct Impact

Any equipment or system that is part of a validated manufacturing process or produce data used to make decision related to product quality will normally be a direct impact system.

or

Any equipment or system whose failure could directly affect the product quality.

Examples include:

1. Process Equipment and Systems

Autoclave, Filling Machine or CIP/SIP system.

2. Laboratory Instruments and Systems

HPLC and Immunoassay system

3. Utilities

Water for Injection (WFI) and Pure Steam

4. Computerized Systems

Building Managements System (BMS) and Laboratory Information Management Systems (LIMS)

All computerized systems which influence the product quality and applications which will support analytical procedures and the batch release shall be categorized according to the GAMP 5 approaches.

GAMP 5

For further reading please refer: ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.