Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0 Objective : The objective of this protocol…
Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e.,…
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…