I would appreciate if anyone can let me know in what cases the FDA will perform an inspection of the cleanroom.

Do we need to call them?

Thanks in advanced for the feedback.

To my knowledge, only companies involved in FDA-regulated industries, INCLUDING BUT NOT LIMITED TO the manufacture of pharmaceuticals, biotechnology products and medical devices, are subject to
FDA inspections. I believe that a company does not call the FDA and request an FDA inspection; the FDA tells you when they are coming. Furthermore, the inspection goes beyond just the cleanroom. All portions of the
manufacturing facility are inspected. Close attention is paid to quality procedures and documents as well as validation procedures. Your Quality Director should have information on what the FDA requires.

You may wish to do web searches on the following topics:
1. FDA Monitoring of Cleanrooms
2. FDA Cleanroom Regulations
3. FDA Audit Checklist (Univ. of Texas document)
4. FDA CGMP Guidelines

Does anyone else in the Forum have direct experience in this area that could comment further?

Hello Howard;

Thank you for the feedback.

We are in fact a Contract Manufacturer of medical devices and we are FDA registered.

We are aware of most of FDA regulations specially the CFR 21 part 820; but I have being tol that there are cases where the FDA needs to approved the functioning of a cleanroom and I just want to be aware of those cases to be prepared for any eventuality.

Regards.

Hi Roldan,
This is in continuation to Howards reply.
FDA shall not come and audit only functioning of cleanroom.
However, in cleanroom qualification the main considerations are, not limiting to
1) AHU / HVAC design considerations and qualification
2) Non-viable particulate count. This needs to be online for ISO 4 / 5 / 6 area.
3) Viable particulate monitoring (refer USP for test details)
4) Cleaning of cleanroom.
5) Monitoring of Environment conditions (temp. & relative humidity). Differential pressure across the rooms.
6) Personnel qualification, entry exit procedure
7) Material inward outward flow
Material used for floor, ceiling, walls. Are the corners coved to avoid particulate accumulation.
9) How is the material handled / processed under cleanroom (under LAF or how)
10) Qualification of utility viz. Compressed air, Nitrogen, Water.
Shall advice you to have a risk assessment done for the cleanrooms considering the activities performed.

For eg. In one of my assignments of manufacturing empty pre-fillable syringes (glass), there were activities like needle bonding and then cleaning. Both were performed in ISO Class 6 (at rest). Still we didnt have online particle counter. The justification was, after needle bonding we had a washing & siliconization machine wihch was automatic without human intervention and activity performed under machine LAF.
This way we saved the budget and utilized in QC instruments.
Incase u still have queries, kindly elaborate your question.

Hi Roldan,
This is in continuation to Howards reply.
FDA shall not come and audit only functioning of cleanroom.
However, in cleanroom qualification the main considerations are, not limiting to
1) AHU / HVAC design considerations and qualification
2) Non-viable particulate count. This needs to be online for ISO 4 / 5 / 6 area.
3) Viable particulate monitoring (refer USP for test details)
4) Cleaning of cleanroom.
5) Monitoring of Environment conditions (temp. & relative humidity). Differential pressure across the rooms.
6) Personnel qualification, entry exit procedure
7) Material inward outward flow
Material used for floor, ceiling, walls. Are the corners coved to avoid particulate accumulation.
9) How is the material handled / processed under cleanroom (under LAF or how)
10) Qualification of utility viz. Compressed air, Nitrogen, Water.
Shall advice you to have a risk assessment done for the cleanrooms considering the activities performed.

For eg. In one of my assignments of manufacturing empty pre-fillable syringes (glass), there were activities like needle bonding and then cleaning. Both were performed in ISO Class 6 (at rest). Still we didnt have online particle counter. The justification was, after needle bonding we had a washing & siliconization machine wihch was automatic without human intervention and activity performed under machine LAF.
This way we saved the budget and utilized in QC instruments.

Hi pharma_4_u,
Nice continuation. Good points.
Thanks for amplifying my response.

Regards
Howard

Hi pharma_4_u,
Nice continuation. Good points.
Thanks for amplifying my response.

Regards
Howard

Hi pharma_4_u,
Nice continuation. Good points.
Thanks for amplifying my response.

Regards
Howard