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FDA guidelines for Calibration Lab needed

S

SGCalLab

Starting to get Involved
#1
#1
Hello,
I am new to the forum and new to the world of cGMP, so please bear with me!
I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed.

My company has tasked me with starting up a calibration lab for process equipment in a nutraceuticals plant. I will need to be compliant with the FDA CGMP's. Where would I find instructions on this?

Thanks.
 
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Ajit Basrur

Ajit Basrur

Staff member
Admin
#2
#2
Re: FDA guidlines for Calibration Lab needed

SGCalLab said:
Hello,
I am new to the forum and new to the world of cGMP, so please bear with me!
I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed.

My company has tasked me with starting up a calibration lab for process equipment in a nutraceuticals plant. I will need to be compliant with the FDA CGMP's. Where would I find instructions on this?

Thanks.
Click to expand...
For a Calibration lab, the starting point for you would be to have ISO 17025 which would be help you in establishing the quality management systems of the calibration lab.

Also have a look at 21 CFR Part 58 form the FDA towards the Good laboratory Practices.

Hope this helps and pl come back if you have additoonal questions :)
 
BradM

BradM

Staff member
Admin
#3
#3
Ajit's suggestion is a good one.

I would suggest getting 21 CFR Part 820.72.

ISO13485 is a good start also. ISO10012 may also be a good purchase.

Also, establishing good practices is as important as anything. Spend some time here looking at good calibration practices. A suggestion:

1. Go spend the money and have adequate calibration ID tags made up. They should be sequential (whatever manner you choose) and unique.

2. Make an inventory of all your equipment, placing the ID tags on the equipment. Be sure and put down location, contact, model/serial number, etc. for each piece of equipment. Also log down if the equipment is calibrated, past due, etc.

3. Compile the information, and determine the necessary time, resources, procedures, etc. before spending a lot of time on it.

It will be necessary for management to understand what it will take to accomplish the job. :)
 
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