CD burner printer IQ/OQ/PQ template

GOOD VALIDATION PRACTICE (cGVP)
1

Please Help. Anybody has an IQ/PQ/OQ for cd burner/printer?

2

Hello,

Why do you need an IQ/OQPQ for a cd burner!

Interesting

3

I’m new with this company and they as me to validate their new Disc Publisher. It’s Primera Bravo II Disc Publisher, burn and print. I need some template to start and i need help.

4

First of all I would check to see what actual manuals (if any) come with this piece of kit.

Alot of the IQ might be sourced from this.

If there are instuction manuals I’m sure you could derive an OQ based on the functionality and it’s intended use.

I run a validation consultancy unfortunately we do not supply templates free to customers.

5

I’ve never heard of validating a cd burner. It’s a mass produce disk copier, I can’t think of any reason to validate one.

6

Now you heard it. The company requires all equipment be subject to validation before they use it. It does’nt matter how big or small the equipment, they want the validation protocol. Anyway, i got some template and I’m almost finish doing the IQ/OQ/PQ and manufacturing Procedures.

thanks anyway