Course Description
Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing and investigations. Topics include cGMP, USP, FDA, ICH and WHO 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, USP <1226> Verification of Compendial Procedures.
Upon completion of this course, you will be able to:
- 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
Who Should Participate:
Scientists, chemists, QA/QC staff and those who perform and manage stability programs
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
The "Pharmaceutical Stability" USP Education course benefits from our extensive PAI catalog of over 740 impurities, including new NDSRIs and impurities associated with USP-NF Monographs.