About Qualification of Equipment and Instrument

Quality Assurance
1

1 What will be the DQ Date of a new installed Equipment e.g. filling sealing machine (vendor DQ)
2- we have DQ IQ OQ documents of New installed Machine from vendor does it mandatory to prepare DQ IQ OQ as per our Qualification SOP protocol of DQ IQ and OQ if yes then date will be same as
Mentioned in vendor DQ IQ and OQ or we will do later
3- If we have not vendor DQ IQ and OQ document of 15 year back installed Machine due to any reason then in Audit how we are justified regarding this.if there is need of qualifications documents how to we provide. Does we prepare it as per our Qualification SOP DQ IQ OQ format .

1 Like
2

Hello!

If you recieve qualification documentation from the supplier, you must review it and verify that it is compliant with your qualification SOP. The date must be traceable to the qualification tests and results reported by the suplier.

If for some reason you donā€™t or canā€™t take your suppliers qualification documentation as it is; you can do them yourself using your suppliers documentation as evidence for some tests or just as reference documentation. It will depend on how well the supplier documentation is prepared and if it is aligned or not with your qualification SOP. If you decide to do the qualifications yourself, dates should be correspondant to your documentation.

If you donā€™t have qualification documentation of an installed/operating equipment, you should assess its impact via process deviation and redo the qualification if necessary. You must have it either by the supplier or by yourself.

I hope this is useful.

1 Like
3

DQ is signed at which time before commissioning of at the time of installation of equipment

4

DQ is signed at the moment of its execution and approval.

DQ of an equipment should be done before its commisioning and installation, the whole purpose of the DQ is to be sure that the design specifications of the equipment will ensure compliance with user and regulatory requirements, so that any risks can be detected before actually constructing and installing the equipment.

1 Like
5

Thanks

6

This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.