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Background The WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted in 2009 a revised version of the Good practices for pharmaceutical quality control laboratories (1). During the inspections carried out when prequalifying laboratories, the inspectors had noticed that some of the texts of these guidelines might benefit from additional guidance, with a special focus […]

Part 210 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Part 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Part 210 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Sec. 210.1 Status of current good manufacturing practice regulations. 210.2 Applicability of current [...]
Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes.  Is this okay? Maybe. It depends on the cause and consistency of the reject rate. Many transdermal patch manufacturing processes produce more waste (i.e., lower yield from theoretical) than other pharmaceutical processes. [...]
Why are there no microbial requirements included in the monographs for Purified Water and Water for Injection? What is the purpose of microbial Alert and Action Levels for Purified Water and Water for Injection? For off-line testing of water samples for Water Conductivity <645> and Total Organic Carbon <643>, how long can I store samples [...]