·
Active
air sampling done at the start, middle, and end of the filling operations.
·
When the bacteria or fungi are detected in
critical ares above the action level or limit their identify the species level.
·
When
this is impossible, the rationale should be documented.
·
Same
organization should be identified may
1. House flora
2. Change a cleaning
agent
3. Corrective action
must be taken.
· Contamination
of raw materials indicating a change in supplier.
· In
such cases corrective action may be more urgent.
· Values exceeding these limits are various
known as excursions, peaks, deviation or out-of-specification (OOS) results.
· When values exceeding regulatory limit the
impact of the manufacturing environment on batch release should be considered.
·
Especially
for critical located in Grade A/B.
·
Pathogenic organism was found that batch
failures and recall procedure must be considered in the investigation.
Classification In operation (Dynamic) routine
particulate
sampling
Grade-A Once per shift /For the full duration
Grade-B Daily
Grade-C weekly
Grade-D monthly
- Different location divided different grades details given below.
Grade
|
Consider Grade
|
A/B Grade
|
A or B Grade
|
A/C Grade
|
B Grade
|
A/D Grade
|
B or C Grade
|
B/C Grade
|
B or C Grade
|
B/D Grade
|
C Grade
|
