1.0 Purpose :
This SOP describes the functions of Microbiology Department
2.0 Scope :
This SOP covers all the functions of the microbiology department
Pertaining to the sampling, analysis, recording and reporting.
3.0 Responsibility :
4.0 Procedure :
4.1 To ensure the safety of the product on bioload by monitoring and alerting QA in case of any unusual occurrence.
Smooth functioning of the department by proper maintenance of cultures Calibration of equipment and drawing schedules for various activities.
4.1.2 To involve in validation activities.
4.1.3 To enforce gowning procedure and hygiene.
4.5 Adherence to cGLP & cGMP requirement.