GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1 - Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it
GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 1
Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful? In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification.

LCGC Europe
Volume 19, Issue 5, pp. 274-283

Figure 3: Classification of laboratory systems by GAMP main guide and the laboratory GPG.
In Appendix M4 of the GAMP Guide is a classification of software into five categories from operating systems (Category 1) to custom or bespoke software (Category 5). This is shown in Figure 3 on the left-hand side. Note, as we have discussed earlier, that more than one class of software can exist in a system; for example, GAMP Categories 1 and 3 for a basic CDS integrator commercial off-the-shelf package running on a PC plus Category 2 firmware within the chromatograph.

In an attempt to be all-encompassing for laboratory systems, the GPG has included ALL instruments, equipment or system with software of any description. Instead of five categories of software, we now have seven (Categories A to G). The categories that have been devised for the Laboratory GPG are based on four principles:

1. Configuration: The software used in the system varies from firmware that cannot be modified, to parameterization of firmware operating functions, proprietary configurable elements up to bespoke software (these are encompassed in GAMP version 4 software categories 2–5).

2. Interfaces: From stand-alone instruments to a single interface to another system and through to multiple interfaces to the system.

3. Data processing: From conversion of analogue to digital signals to post-acquisition processing.

4. Results and data storage: From no data generated to methods, electronic records and post-acquisition processing results.

However, the approach outlined in the GPG is wrong again as it separates and isolates the laboratory from the rest of the organization when in reality it is an integral part of any regulated operation from R&D to manufacturing. We cannot have an interpreter at the door of the laboratory who interprets the GAMP categories used in the rest of an organization to Lablish (Laboratory computerized system validation English). There needs to be a single, unified approach to computerized system validation throughout an organization at a high level that acknowledges that there will be differences in approach as one gets closer to the individual quality systems, for example, GMP, GLP etc., and the individual computer systems. To do otherwise is sheer stupidity.

Do You Really Want to Validate a Dishwasher?

Some of the typical systems classified by the GPG are shown in Figure 3 on the right-hand side. In contrast, the left-hand side and centre columns show how systems from the traditional GAMP software categories map to the new GPG categories. You'll also note that a system can be classified in more than one GPG class depending on the software functions. In devising this classification system, the GPG proposes to include balances, pH meters, centrifuges and glass washers as "laboratory computerized systems". Strictly speaking this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function.

According to the main GAMP Guide all these items of equipment would be classified as Category 2 and "qualified" as fit for intended use. Under the Laboratory GPG, they are split into two classes (A and B) and are "validated" as fit for purpose. The comparison of the GAMP Guide and the Laboratory GPG software classifications are shown in Figure 3 on the right-hand side of the diagram and the arrows in the middle indicate how the two classification systems are mapped and are compared with each other.

The horror that some of you may be having now around the suggestion to validate a balance, pH meter or centrifuge is more about terminology used rather than the work that you would do. Moreover, as we get to more complex laboratory systems such as LIMS the Laboratory GPG suggests that GAMP 4 categories may be more suitable! It really depends on the functions that the equipment or system does and how critical it is.


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