Is there any specific guideline about the microbiological environmental monitoring in hazardous manufacturing sites (Only in operation state). I want to know the required regulatory about monitoring such these places. Is that necessary or not? Because in during manufacturing and processing these products, the operator must be taken rough specific suit protection. and also the air and surface of these sites have many hazardous aerosol and If microbial monitoring was performed, the whole of plates, air sampler and etc, were contaminated with dangerous powder. I want some documents that guide me about the issues. My means about the hazardous products are especially Those products that be used for cure cancers (like Capecitabine, Imatinib, Lenalidomide and etc). Thanks
Major observations have specifically been issued to companies that lack adequate systems for monitoring environmental conditions in aseptic processing areas and for not having written procedures. Environmental sampling, as with all laboratory testing, should not be conducted if there is no plan for.....The important indication for sampling is to monitor a potentially hazardous environmental condition ...........https://www.cdc.gov -Centers for Disease Control and Prevention
Dear Moien,
Here is an attachment below related to your querry.
https://www.pharmaceuticalonline.com/doc/designing-an-environmental-monitoring-program-for-non-sterile-manufacturing-a-risk-based-approach-0001
Good Luck.
Piyush Kumar I don't want a general guideline about the all non sterile, whereas My main goal is about hazardous products.
Dear Moein,
The EPA guide might help you: https://www.epa.gov/sites/production/files/2015-06/documents/fieldsamp-ecologicalassess.pdf
All the best,
Arizaldo