Microscope – Operation & Calibration Procedure
Standard Operating Procedure (SOP) for operation & calibration of digital microscope. A microscope consists of a compound magnifying system in which the observer looks at the first (primary) image with…
Environmental Monitoring Guide – Non Sterile Facility
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…
Environmental Monitoring (EM) – New Approach Guide
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…
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