Equipment Validation classification

TEMPLATES & PRESENTATIONS
1

I wish to know how will u classify your equipments or machines for validation purpose.
Is a guideline available for classifying equipment in critical or non critical equipment category where by validation is required or can be omitted.

2

[quote=shank]I wish to know how will u classify your equipments or machines for validation purpose.
Is a guideline available for classifying equipment in critical or non critical equipment category where by validation is required or can be omitted.[/quote]

You can use risk based approach and catergorized by criticality basis.

Thanks

3

Hi Shank

You have to use a form of risk assessment. In this case the risk you are assessing is what scope of validation is required to ensure the equipment is qualified to GMP standards. If you go to

you will find full details on constructing and using a VRA. Remember you are only assessing the scope of validation required, definitely not the efficacy, efficiency or design.

The regulatory authorities require this decision to be documented, and available to them for review.

Alex Kennedy