Criteria for categorisation of GAMP 3 and GAMP 5 of standalone systems

[v9991]

Need advice on classifiction of software in typical stand alone instruments in pharmaceutical analytical laboratory.

option-1 in my opinion, the software is "configured" ( hence category-4) ; and it involves, specific setup involving user management, privileges, instrument parameters specific to each product or material; processing and reporting of the results. etc.,

option02 is that the software is out of the box functionalities ( irrespective of the configuration) hence it is category-3.

hope to hear your thoughts and conclusions

 

[Tidge]

What is the intended use of the instrument?

 

[v9991]

What is the intended use of the instrument?

The intended use of the application is a typical pharmaceutical analytical laboratory, with a varied range of operations/configurations
a, predefined operating ranges which can be selected specific to the products/measurements.
b. predefined operating ranges, which can be made into recipes, and then selected to operate for a given product or measurement.

in short all the equipment are under the purview of GxP, with indirect impact on the product quality ( as they are measurement equipment ); and governed by the IQ/OQ/PQ and calibration criteria as governed by respective USP etc.

 

[Tidge]

Looks like category 4, per appendix M4.