Corrective Action and Preventive Action

SOP For Corrective Action and Preventive Actions

Quality Assurance

SOP For Corrective Action and Preventive Actions   OBJECTIVE: Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP. SCOPE: This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility… RESPONSIBILITY: Officer …

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Pharmaceutical Quality System Elements & Change Management System (ICHQ10)

Quality Assurance

Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: • Process performance and product quality monitoring …

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