New Area microbiological QUALIFICATION

GOOD VALIDATION PRACTICE (cGVP)
1

Dear all,
I think I will need your help on the following:
Is there any reference guideline that I could be based on for the microbiological qualification of a newly installed area ?

It is about an area for the filling of sterile solutions. I would like to prove that the area is qualified for its purported use and I will need to include in my qualification parameters microbiological controls as well.

Thanks a lot for your help.

Cooly

2

[quote=Cooly]Dear all,
I think I will need your help on the following:
Is there any reference guideline that I could be based on for the microbiological qualification of a newly installed area ?

It is about an area for the filling of sterile solutions. I would like to prove that the area is qualified for its purported use and I will need to include in my qualification parameters microbiological controls as well.

Thanks a lot for your help.

Cooly[/quote]

Dear Cooly,
I believe air sampling control, petri dishes, environmental control are the basics to start with a new area.

Best regards,