Posts Tagged ‘Qualification/Validation’


Risk management: must-have for any pharmaceutical company

Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing risks that affect the quality of a medicinal product. An efficiently implemented quality risk management system (QRM) ensures the quality of products throughout the entire life cycles and is an enabler of the Pharmaceutical Quality System (PQS). …more






Mini white paper: Evolution in the validation world

Only a few decades ago, in the pharmaceutical industry, it was an acceptable practice to verify packaging machinery only by observing equipment run and checking basic functions. Since the 70’s, the industry has gone through a major change. Many regulations, standards, and guidelines that govern CQV (Commissioning, Qualification and Validation) practices were put in place. With that said, the commensurate level of adaptation was required. …more


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