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Process Validation can be defined as the documented
evidence that the process, within the established
parameters, can perform effectively and reproducibly to
produce a product that meets its predetermined
specifications and quality attributes.It provides a documented high degree of assurance that
your process operates under a state of control.
• Modern Process Validation methodologies incorporates a
life cycle approach that links products, process
development, validation of the commercial
manufacturing process and maintenance of the process
in a state o control during routine commercial
ICH Q9, Quality Risk Management was issued in June 2006. This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products.