Frquency of Environmental monitoring in Grade D

GOOD MANUFACTURING PRACTICE (cGMP)
1

Dear all,

Q1:
What is the frquency followed for Environmental monitoring (settle plate and air sampling techniques) in Grade D (Non-Sterile areas) ?. What is the practice in industry ?. Is there any regulatory requirement?

Q2:
How important is monitoring of compressed air in pharmaceuticals and what is monitoring frequency ?

pls. advise…

Thanks,
SKY

2

according to regulations enviromental monitoring in a grade D area is done monthly.how it can depend on our in house specifications also.In our company we do it every week.

3

in a sterile industry monitoring of compressed air is very much important,as it is used during vial filling operation,its monitoring is done every for every 15 days.