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Pharmaceutical Good Manufacturing Practices (GMP) thrive on Good Documentation Practices (GDP). It is one of the most important requirements of the Quality Management System. It is popularly said that “Anything which is not documented, is not done”. Documentation is the…
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…
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…
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…
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…