Equipment Validation

Should all new equipment in lab go through a validation process? And, if so an example of an SOP or form to help comply for FDA or cGMP regulation.

Here we are mixing two issues, as per me all the critical equipments need to undergo qualification. Criticality of instruments depends on for what it is used, its priciple of working and effecto of the results/output of the equipment on the product quality. Extent of qualification can be decided on basis of risk assessment. A small example,
If water bath used in microbilogy department for melting of media, it did not undergo qualification for temperature accuracy. But iof t is used in chemical lab for any raction in such cases thermostat needs to qualified. Hope this helps you.


Risk, risk, risk assessment. It is the best documented form of decision making that exists. As with all equipment whether it be utilities, lab or process, one needs to make an informed decision and the best way to handle that is with a simple risk assessment that checks for eg. if the system has direct contact with the product (e.g. air quality), or if the system provides an excipient, or produces an ingredient or solvent (e.g. water for injection) or if the system is used in cleaning or sterilization (e.g. Clean steam)or if the system produces data which is used to accept or reject product (e.g. Electronic batch record system) etc.

Hope that this is of some help