General IQ and OQ template

TEMPLATES & PRESENTATIONS TEMPLATES
1

Hi all,

I have to prepare separate IQ, OQ or IQOQ (or IQOQ) protocols for each equipment. Number of protocols is overwhelming.
I have an idea to create general template for IQ testing. It would have a check list form and include all potential test.
This template would be approved in two ways: by signatures and in the system.
I wonder if these signatures would be adequate to fullfill the requirement “qualification need to be performed in accordance with pre-approved protocols”.

It all seems quite easy for IQ, but for OQ is not. Main tests will be the same for all devices, but there is a issue of device specific test.
Do you have experience with general OQ templates? is it possible to write a general test for device main function which will be siutable for all devices?

I kindly ask for your advice.

Marta

2

Hi Marta,

You should be able to create generic IQ and OQ protocols for each type of equipment, such as

  • HPLC
  • UV spectrophotometer
  • Dissolution
  • Balance

Due to the wide verity of functionality for different types of equipment, creating a single document to fit all is probably not a viable option. However, as the general content of IQ and OQ protocols for equipment within the same GAMP category are quite similar and I have developed protocol templates based on GAMP category in the past. It is not to difficult for GAMP4 category 2, things like pH meter, balance and stand alone manual dissolution.

“An Easy to Understand Guide to HPLC Validation” available on this web site contains example extracts from the different documents needed.

I am not sure I understand your sentence This template would be approved in two ways: by signatures and in the system.

So I can not help there.

incidentally, I would advocate forming a qualification team to carry out equipment qualification consisting of all stake holders.

Please feel free to PM me and I would be please to offer any help I can.

Kind regards

David

Dr David Trew
BSc (Hons), PhD, CChem MRSC

3

Hi, you can generate templates only for similar equipment, like HPLC’s, UV’s and others.I performed IQ, OQ and PQ with different templates for different equipment and signed and dated every page of document.
Best Regards K. Arzakanyan, QA at Liqvor pharmaceuticals, Armenia, Yerevan

4

Thank you for replies. It seems that it won’t be easy.
I have an idea how to prepare general IQ template, but still working on it.

However, I am concerned by OQ general templates… In my situation, preparation a template for a group of similar equipment will not be helpfull.

Thanks again,
Marta

5

Hi, If you want to generate IQ and OQ templates, you have to use instruction manuals for each equipment.In the equipment instruction manual you have to find specification part and use it.
Best regards K. Arzakanyan, QA at Liqvor Pharmaceuticals, Armenia, Yerevan