Unit 2: Regulatory Framework and Guidelines
This unit covers the essential regulatory guidelines and frameworks governing analytical laboratories, including ICH guidelines, USP chapters, GMP and GLP principles, and documentation standards. It ensures compliance with global quality requirements for analytical method development and validation.
The International Council for Harmonisation (ICH) provides globally accepted guidelines for pharmaceutical development and quality assurance. For analytical methods, ICH Q2(R1) is the primary guideline for validation, covering parameters like accuracy, precision, specificity, detection limit, quantitation limit, linearity, and robustness.
Key Points
ICH Q2(R1): Validation of Analytical Procedures.
ICH Q8: Pharmaceutical Development.
ICH Q9: Quality Risk Management.
ICH Q10: Pharmaceutical Quality System.
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