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Pharma Industry is a dynamic and highly regulated industry where mistakes, deviations are bound to happen. But what is expected from a quality conscious firm is not to hide the facts but to identify the mistake, report, investigate, identify root…
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk…
Value Stream Mapping (VSM) is a lean technique used in manufacturing to analyze & manage the design and flow of information & materials to provide satisfactory products to the customers. Each step in a process can be documented with the…
May 5, 2020 Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia has notified that they are intending to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as…
As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk…