System Suitability Requirements and Update on Harmonization of USP General Chapter <621> Chromatography
Instructor:
Behnam Davani
Product ID: 705767
Training Level: Basic to Intermediate
- Duration: 60 Min
Why Should You Attend:
<621> is one of the most important USP general chapters impacting about 5000 USP monographs. Establishing meaningful system suitability criteria for chromatography procedures are requirements for a valid procedure and compendial and regulatory compliance.
In this webinar Dr. Davani will discuss an overview of system suitability requirements, and allowed adjustments to specific chromatographic systems in the USP monographs based on General Chapter <621> Chromatography. In addition, the update on harmonization of this general chapter with the two other major pharmacopeias (EP and JP) will be discussed for the smooth procedure implementation by users when these changes become official.
Use of alternative method to compendial (official) procedure and the potential options available will be discussed. In addition, guidance on identifying effective system suitability parameters and acceptance criteria for up-to-date (modernized) USP monographs as well as different quantitation strategies for impurities will be provided.
Areas Covered in the Webinar:
- System suitability requirements and allowable chromatographic system adjustments
- How to Establish meaningful criteria for system suitability criteria
- Update on USP Monograph Modernization in collaboration with FDA
- Update on Harmonization of <621>
- Alternative procedure to official procedure
- Quantitation of impurities using different approaches and pros and cons of each option
Who Will Benefit:
- Analytical Chemists
- Lab Supervisors and Managers
- Reviewers of Compendial procedures
- QC Managers and Personnel
- QA Managers and Personnel
- Regulatory personnel who submit official procedures to FDA for approval
- CRO/Contract labs
Behnam Davani
Senior Consultant and Managing Director, Davani Pharmaceutical Consulting
Dr. Behnam Davani is an Independent Senior Consultant and Managing Director of Davani Pharmaceutical Consulting. He has a Ph.D. degree in analytical chemistry and holds an MBA degree. Dr. Davani has more than 28 years of experience in industry, compendial/regulatory science and training. He has extensive experience as faculty for the development and teaching of several compendial and cGMP courses both domestically and internationally for USP Global Education Program. Dr. Davani is also editor and author of a recent book: "Pharmaceutical Analysis for Small Molecules", published by Wiley in 2017.
Prior to forming his own consulting company in 2017, he worked at USP for 17 years in different capacities including Director of Chemical Medicine Department and the Principal Scientific Liaison. His last responsibly at USP was the scientific management of the content development and teaching of USP Education courses for stakeholders worldwide. He was also a faculty for several Pharmacopeial Education courses both domestic and internationally. These topics include validation/verification/transfer of analytical procedures, impurities in drug substances and drug products, compendial HPLC, residual solvents, spectroscopy and stability studies for pharmaceutical products. In addition, he provided scientific support to the USP International Regulatory Affairs Department and Global Public Health Department for outreach and training for international regulatory agencies. Before joining USP in 1999, Dr. Davani worked in industry in various technical management positions for more than ten years.
Topic Background:
System suitability (SS) requirements are integral part of chromatography methods and are needed for regulatory (FDA) and USP compliance. However, there are some older USP monographs that do not have adequate or effective SS parameters and criteria. As part of USP Monograph Up-to-Date (Modernization) Initiative, the new developed monographs and recent revisions include more meaningful system suitability requirements. Attempts are also underway to modernize the remaining outdated monographs. The details and insights to address these issues will be discussed using some real examples and case studies. In addition, General Chapter <621> is undergoing international harmonization with European Pharmacopeia (EP) and Japanese Pharmacopoeia (JP). The proposed updated harmonization revisions and the impact on the monographs and compliance will also be discussed.
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