I would talk about validation of laboratory equipment.
In my Factory, the QC (Quality Control) decided to entrust operations about IQ, OQ, software, to external contractor who executes IQ and OQ of laboratory equipments (for example spectrometer FTiR). At the same time it isn’t executed any validation by internal QC System; I would like to know your opinion.
Is this approach correct for you?
Is it maybe necessary to execute internal validation protocols by considering that qualification of external contractor is not enough?
My opinion is that there is differences between qualification vs validation, is it correct?
May anyone suggest me GMP correct approach by regulations?
What is the Regulations to follow?
US FDA 21 CFR 820 (cGMP) requires assurance that manufacturers control and monitor production processes to ensure that a device conforms to its specifications (820.70(a)). Further, where results of a process cannot be verified by subsequent inspection and test, the process shall be validated… (820.75(a)).
You define, based on a defined risk assessment, the level to which equipment and processes are deemed acceptable. Without knowing more about your product and how the equipment affects the product, it’s not really possible to say what should be done.
Using contractors to conduct qualification / validation is certainly acceptable. Realize, though, that if regulators do not accept the results from the contractor, your company is held liable (you can’t “blame” the contractors for not doing the right thing). So while contractors may certainly be used to do the work, someone in your company needs to be aware of the regulations to ensure that the contractors are doing what is required and doing it correctly.
You need to check out the GAMP Laboratories Guide to Computerized systems. It details different approaches based on system impact and risk.
Equipment is a "mass noun."
That means that if you want to refer to multiple units, it is still equipment (not equipments!)
You wouldn’t say “last night I threw out the garbages” or “trashes.” Even if there were multiple bags, it’s still garbage or trash.
Same with laboratory equipment. If you want to refer to more than one, you can say units of equipment or pieces of equipment, etc.
[quote=validnation]Equipment is a "mass noun."
That means that if you want to refer to multiple units, it is still equipment (not equipments!)
You wouldn’t say “last night I threw out the garbages” or “trashes.” Even if there were multiple bags, it’s still garbage or trash.
Same with laboratory equipment. If you want to refer to more than one, you can say units of equipment or pieces of equipment, etc.[/quote]
Seems to me as a very valuable hint. Is this a forum for english learners or valdation purposes? Excuse me in advance if I wrote anything wrong.
@ validnation…There is no need for this type of comment.
This is a friendly forum for everyone to exchange ideas…Not everyone will have perfect English.
Regards
[quote=gokeeffe]@ validnation…There is no need for this type of comment.
This is a friendly forum for everyone to exchange ideas…Not everyone will have perfect English.
Regards[/quote]
I would just like to say I only speak and write one language. I doubt very much that I would be able to construct a perfect grammatical masterpiece in another language. Lets keep it to the subject matter.