Unit 11: Regulatory & Quality Aspects
Regulatory and quality aspects ensure compliance with GMP, GLP, and data integrity standards throughout drug development and manufacturing. Key elements include ALCOA principles, documentation, and stability studies as per ICH guidelines.
Definition
Regulatory and quality aspects ensure that pharmaceutical products meet safety, efficacy, and compliance standards throughout development and manufacturing.
These include Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), documentation standards, ALCOA principles, and stability testing as per ICH guidelines.
Key Points
GMP ensures product quality during manufacturing
GLP governs non-clinical laboratory studies
ALCOA principles ensure data integrity
Stability studies follow ICH guidelines
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