System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance

Duration: 90 Minutes
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Due to the criticality of the data generated in a pharmaceutical laboratory, System Suitability Testing (SST) has been implemented to provide input on a daily basis about whether or not an analytical method is performing as intended.
System Suitability Testing
Instructor: Gregory Martin
Product ID: 509647
Objectives of the Presentation
  • Understand the FDA and USP Requirements for System Suitability Testing
  • Learn which parameters should be included in SST, and how they relate to USP General Chapter <621>
  • Understand how SST, Instrument Qualification and Quality Controls are related, and how they are different
  • Learn what to do if your method fails to meet SST requirements
Why Should you Attend
This webinar will address the rationale behind System Suitability Testing, how to establish SST as an effective Analytical Control Strategy and what to do if SST does NOT conform to the expectations. We will discuss USP General Chapter <621>, including which analytical parameters may be adjusted to achieve passing SST results.

Areas Covered
  • FDA and USP Requirements for System Suitability Testing (SST)
  • System Suitability Testing as an integral part of Analytical Control Strategy
  • Which Parameters should be included in SST?
  • How does SST relate to USP <621> Chromatography
  • What if you fail the SST criteria?
  • Understanding the relationship among SST, Instrument Qualification and Quality Control Samples
  • Recommendations for non-chromatographic methods
  • Attendee Questions
Who will Benefit
Chemists (Research, Quality Control, and CRO; Human, Veterinary, Generic or Dietary Supplements) involved with dissolution method development or testing and their managers, QA personnel responsible for reviewing investigations, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution, Laboratory managers and supervisors , Quality Assurance Managers , GMP auditors ,Consultants.

Topic Background
System suitability testing (SST) is required by USP and FDA to check and ensure on-going performance of analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and other agencies. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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