Guideline (SOP) for risk based Environmental Monitoring (EM) in Non Sterile drug manufacturing facility. Regulatory standards for non-sterile product manufacture and environmental control have not been consistently established, however, EU…
This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area personnel gown and glove samples, and for utility systems supplying…
Standard Operating Procedure (SOP) for procedure for Validation / Qualification of Steam Sterilizer used in microbiology laboratories. Validation of Steam Sterilizer 1.0 Purpose: To lay down the procedure for Validation…