Guideline (SOP) for risk based Environmental Monitoring (EM) in Non Sterile drug manufacturing facility. Regulatory standards for non-sterile product manufacture.
This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area.
Standard Operating Procedure (SOP) for procedure for Validation / Qualification of Steam Sterilizer used in microbiology laboratories. Validation of Steam.
Standard Operating Procedure (SOP) for Operation, Cleaning and Calibration of Newtronic make BOD Incubator used in microbiology department for analytical.
Standard Operating Procedure (SOP) for Operation, Cleaning and Qualification of Biosafety Cabinet (ESCO) used to storage of Microbiological Media, Cultures.