Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing, and investigations. Topics include cGMP, USP, FDA, and ICH stability requirements for establishing expiration dating and label storage criteria; technical and regulatory aspects that may affect design cost-effectiveness and compliance; and stability-indicating methods for monitoring product quality throughout its shelf life. Matrix and bracketing options to reduce testing, stability data evaluation and investigation of out-of-trend and out-of-specifications are also addressed. This course will also cover USP <1225> Validation of Compendial Procedures, and USP <1226> Verification of Compendial Procedures
Subject area:
cGMP
Drug Products & APIs
Objectives (If applicable):
• Identify the requirements of stability testing
• Describe the critical role of drug stability
• Interpret 21 CRF 211 as it relates to stability
• Explain the ICH process and Q1A
• Recognize the stability protocol for global submission
• Utilize stability-indicating test methods
• Interpret the ICH Q2 A/B on analytical method validation
• Identify critical steps of the stability process
• Identify benefits and drawbacks of bracketing and matrixing
• Evaluate stability data
• Determine corrective and preventative actions
Target Audience (If applicable):
Scientists, chemists, QA/QC staff and those who perform and manage stability programs