ICH Q10

Pharmaceutical Quality System Elements & Change Management System (ICHQ10)

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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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MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10)

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MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Resource Management (a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain …

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