Protocol equipment holding time study have following
content:
1.Purpose
2.Scope
3.Responsibilities
4.Details
of Equipment
5.Sampling
plan
6.Sampling
and analysis procedure
7.Acceptance
criteria
8.Report preparation and evaluation of
results
9.Conclusion
Purpose:
Purpose of the study of dirty equipment holding time
study and this protocol is to establish holding time of dirty equipments by
studying Microbial load and cleaning of the equipment after holding for
specified period till next batch or next product is manufactured by using same
equipment.
Scope:
This
protocol is applicable to for the all dirty equipment which used to
manufacturing of active pharmaceutical ingredient.
Responsibilities:
Quality assurance: To prepare and review the
protocol.
To execute the protocol and coordinate for
the activity perform during the execution of the protocol
QC/Microbiology: To collect the sample from
the equipment
To analyse of sample.
Production:
To
support the other department to complete the all activities.
Details of Equipment:
The
details of the equipment in which the dirty equipment holding time study is
going to performed.
Sampling plan:
How
many days or hour study going to performed, Frequency of the dirty holding time
study. It depend on the time period the dirty equipment need to be hold.
Sampling and analysis procedure:
The
procedure which follow for the dirty
equipment holding time study.
It
include
1.
Microbial
analysis
To check presence the
any microbial growth into the equipment.
2.
Chemical
Analysis:
To check the impurity
profile if there is any change
To check the presence
of any residue after cleaning
Acceptance criteria:
As per available
specification.
Report
preparation and evaluation of results:
To compile all the results and compilation
in sheet and on evaluation of the result from results
Conclusion:
According
to result conclusion how many days/hour you can keep equipment in uncleaned
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