Dear Friends,
Our facility does not comply as per GMP requirements (15 years old). In controlled area particle count(PC) is monitored daily (reason unknown), but as per ISO, PC is monitored either 06 or 12 months once.Sometime the count in certain location cross the action limit.
- In this case whether it will be addressed as Incidence or OOS (When does
not complies the limit). - Since facility does not comply to GMP requirement is it mandatory to
record PC on daily basis?
Can any one suggest the possible corrective action which can be addressed for this issue.
Thanks
Sowmya