Protocol of Dirty equipment holding time study

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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