Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (a)

[chasf]

Can anyone tell me if it is common to validate the the equipment, software and processes for the manufacturing of a medical device? This will soon become a requirement of one of our customers they tell us it is being fueled by the FDA. My understanding was that Validation was only required under 21CFR 820.75 (a).

Sec. 820.75 Process validation.

(a) Where the results of a process cannot be fully verified by subsequent
inspection and test, the process shall be validated with a high degree of
assurance and approved according to established procedures. The
validation activities and results, including the date and signature of the
individual(s) approving the validation and where appropriate the major
equipment validated, shall be documented.

 

[Al Rosen]

Re: Validation for Medical Devices

Can anyone tell me if it is common to validate the the equipment, software and processes for the manufacturing of a medical device? This will soon become a requirement of one of our customers they tell us it is being fueled by the FDA. My understanding was that Validation was only required under 21CFR 820.75 (a).

Sec. 820.75 Process validation.

(a) Where the results of a process cannot be fully verified by subsequent
inspection and test, the process shall be validated with a high degree of
assurance and approved according to established procedures. The
validation activities and results, including the date and signature of the
individual(s) approving the validation and where appropriate the major
equipment validated, shall be documented.

It is common and FDA will want you to validate your processes. Also look at the GHTF Guidance for Process Validation.

 

[yodon]

Re: Validation for Medical Devices

Note that 820.75 is under subpart G, Production (aka manufacturing) and Process Controls. So, as Al points out, validation will be expected.

One area (I'm sure there are others) that seems to be hit often is soldering. You can't 100% verify the results without destruction so soldering is expected to be a validated process. Another area is sterilization. If the device is sterilized, the sterilization process must be validated.

 

[Al Rosen]

Re: Validation for Medical Devices

Note that 820.75 is under subpart G, Production (aka manufacturing) and Process Controls. So, as Al points out, validation will be expected.

One area (I'm sure there are others) that seems to be hit often is soldering. You can't 100% verify the results without destruction so soldering is expected to be a validated process. Another area is sterilization. If the device is sterilized, the sterilization process must be validated.

There is also a list of processes in the guidance that I posted. It's not comprehensive but it's a start.

 

[chasf]

Re: Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (

Thanks for your input. It makes sense to apply 820.75 to a soldering process but we are being required to validate all processes such as turning, milling and drilling. These processes can be measured and verified. Also the software used in the CNC machinery is to be validated as well. Does this sound reasonable?

 

[Al Rosen]

Re: Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (

Thanks for your input. It makes sense to apply 820.75 to a soldering process but we are being required to validate all processes such as turning, milling and drilling. These processes can be measured and verified. Also the software used in the CNC machinery is to be validated as well. Does this sound reasonable?

If you want to inspect or verify every characteristic rather than validate, you may be able to make an argument, but you should at least validate your CNC software. BTW, reasonable and regulations are sometimes oxymorons. See 21CFR820.70(i).

 

[chasf]

Re: Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (

Verification of characteristicis is done by using a sampling plan during production. Does that sound reasonable? Also I should make it clear that we subcontract for Medical Device companies the product is primarily implantable devices.

 

[Roland Cooke]

Re: Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (

Validation of processes is basically done for one of three reasons:

1) You can't test/inspect for it, so you have to validate. Sterilisation is the obvious example here.

2) You can test/inspect for it, but it is more economical to have a validated process instead. Automated camera inspection systems are a good example.

3) The process doesn't need validation (presumably because of subsequent inspection), but the company opts to validate every process anyway, as a belt 'n' braces approach.

 

[chasf]

Re: Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (

That makes good sense Roland but what I am getting form one customer in particular is that all Processes including all subcontracted processes must be validated. This includes software and installation. Do you have any recommendations?

 

[Roland Cooke]

Re: Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (

Then your customer is an idiot. It happens.

Do you actually install anything? If not, it makes validating that process really rather hard.



Hopefully your customer has merely shortcut what he really means for you to have in place.

What you need to do is to map your processes and identify how you know each of them are going to work to an agreed level of satisfaction. That will either be via inspection/testing, or by validation.

(By the way, software isn't a process. Software might well control a process, and thus may well need to be validated to ensure that it performs the control task correctly. Software may need validation in its own right of course, some medical devices are indeed simply CD-ROMs.)

edit: if you want to know more about validating processes, search this forum, and the FDA website. There is a ton of stuff available.