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to safer inspection processes and less discussions in GMP inspections, as the described approach has shown its suitability during many years of industrial operation and GMP inspections. 2. Manual inspection 2.1 Workplace The premises where the manual visual inspection takes place should be suitable for carrying out this operation. Besides the
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Key Words: Indian GMP, Schedule M, US cGMP, USFDA Comparative Study of Good Manufacturing Practice (GMPs) Requirements for Sterile Pharmaceutical Products in USA and INDIA Article history: Received 18 Feb 2014 Accepted 10 March 2014 Available online 13 April 2014 products is subject to special requirements in order to minimize risks o
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