Labelling

GOOD VALIDATION PRACTICE (cGVP)
1

Hello!

We have bougth a labelling machine with a label printer and a OCV system in order to detect faultys in the labels.

I’d like to know your advices, opinions, inputs… for the validation of this system. What I must done in the IQ, OQ, PQ… etc?

Thanks in advance

2

hi,

this is a loaded question, having just completed a validation of a labelling machine which took in all 2 months to validate, I could sit here all day typing this response, I have a few questions first;

Q 1. Is the OCV system from a different vendor than the machine?

Q 2. why have you not bought validation documentation with the system?

Ruth

3

[quote=Oscar_bcn]Hello!

We have bougth a labelling machine with a label printer and a OCV system in order to detect faultys in the labels.

I’d like to know your advices, opinions, inputs… for the validation of this system. What I must done in the IQ, OQ, PQ… etc?

Thanks in advance[/quote]

Dear oscar
whatever Machine is that any one can guide u generally, but u should look into this matter that what operating parameters are there and how system operates consistently with in defined specifications and parameters. Anyways if you send me its specifications, i may help you out for the preparation of protocol.

4

Hello Ruth,
Yes, the OCV vendor is different than the machine vendor, and the second answer is that we have bougth the validation, but these vendors aren’t very good (about validation)… So we have to approbe the validation doc before it starts

Thank you for your answer Ruth

5

[quote=Oscar_bcn]Hello Ruth,
…and the second answer is that we have bougth the validation, but these vendors aren’t very good (about validation)… So we have to approbe the validation doc before it starts[/quote] I always like this one. In whose opinion is the validation poor, QA?. I find that although I could probably be more detailed in my validation, the validation from a vendor is satisfactory. From a risk based approach, what is the risk that their validation is in adequate and issues won’t be found in a PQ. The work is already performed, use it. I would do a quick gap analysis to make sure the vendor documents are not grossly inadequate but I would focus on the PQ. I am trying to remember if an auditor has ever asked or made a comment on an inadequate IQ when the PQ was successful.