USP General Chapters <1225> and <1226> provide guidance on how to ensure test methods are executed consistently and qualified for their intended purpose. These Chapters have had significant impact on those in the pharmaceutical industry who face challenges with managing excipients and API supply chains. Such challenges include—lack of method detail, differences in material between manufacturers, investigations and identifying root cause.
Investigations for testing failures pose significant challenges for the testing laboratory and for the QCU who is being pressured to release materials for production. The root issue for these investigations is frequently found in poor methodology with insufficient verification to demonstrate acceptability for intended requirements.
By participating in this webinar you will learn:
- Types of analytical methods requiring verification
- What is required to demonstrate that methods can be run successfully in a laboratory
- Actions to take when method is found not suitable for intended purpose
- Approaches for qualification for non-compendial products
- How to track performance of execution of standard compendia methods with the laboratory
Discussion points include:
- Verification and potential validation of compendia methodology for non-compendial products. General approaches and consideration in accordance with published guidance.
- Testing of cell substrates and process intermediates
- Investigations that result in conclusive evidence that methodology is unsuitable for intended use
- Approach to addressing issues with analytical procedures. Finding root cause and implementing effective corrective action.
- Use of innovative approaches, including performance based methods to demonstrate method validity in matrix contingent analyses such as trace metals and residual solvents.
Pauline McGregor, Ph.D., CChem, MRSC, president, PMcG Consulting, Canada
Over 20 years in the pharmaceutical industry has included working for companies such as Syntex, Pfizer and Novocol as well as Contract Testing Laboratories in Canada and the UK. Pauline completed her honours degree and Ph.D. in Edinburgh, Scotland. On completing her Ph.D. in 1995, she travelled to UWO in London and Ontario, Canada to complete her post-doctoral studies. Since then she has worked as a validation specialist at Pfizer, a manager of research, development and validation in a contract testing laboratory and a consultant and trainer in the pharmaceutical industry. She has taught analytical R&D, method validation, transfer and verification, GMP, and related quality systems courses in Canada, US, UK, Jordan and China. Throughout her career, Pauline has been involved with and has had a passionate interest in the evolution of method development, validation, transfer and verification of analytical methods and has been actively involved in authoring a paper and presenting short talks and training sessions on the application of QbD to analytical methods. She is currently a member of the Royal Society of Chemistry, UK, and a proud member of the USP Expert Panel for Validation, Verification and Transfer of Analytical Procedures.
Travis Emig, director, Pharmaceutical Chemistry, Lancaster Laboratories
With 20 years of experience, Mr. Emig has served Lancaster Laboratories in numerous capacities ranging from chemist for Method Validation, Raw Materials and Stability and coordinator of Pharmaceutical Product Testing to manager, and now director, of Pharmaceutical Chemistry where he leads operations for Lancaster Labs’ Lancaster, Pennsylvania and Portage, Michigan facilities. His specialties include analytical chemistry, chromatography, investigation process, regulatory trends, KPI based operations management and creating innovative service models for customers. Mr. Emig earned a B.S. in chemistry from Lebanon Valley College.
Kimberly Rhoades, manager, Pharmaceutical Raw Materials, Lancaster Laboratories
Ms. Rhoades has been with Lancaster Laboratories since 1999, starting as a chemist in the Raw Material Department and transferring into a Group Leader and specializing in analytical chemistry with a concentration on polarimetry, thin layer chromatography and assays by titrations. She now manages the raw material operations for Lancaster Laboratories overseeing quality and compliance in order to meet client requirements and regulatory standards. Ms. Rhoades earned a B.S. in biology from the University of Pittsburgh at Bradford.
Terry Schuck, principal chemist/group leader, Pharmaceutical Raw Materials, Lancaster Laboratories
As principal chemist and group leader for Lancaster Laboratories’ Raw Materials Group for 15 years, Mr. Schuck oversees validation projects in areas of GC, ICP and general wet chemistry testing. He also supervises and trains analysts and serves as the technical contact for raw material projects. He earned a bachelor of science degree in environmental resource management from the Pennsylvania State University in 1984.
Who Should Attend?
This program is intended for individuals involved in material qualifications, laboratory method establishment or the approval of raw material supplies for manufacturing including:
- Quality Assurance & Quality Control
- Research & Development
- Analytical leaders charged with method verification/validation for raw materials
With a proven track record of providing quality scientific solutions for 19 of the top 20 largest pharmaceutical/biopharmaceutical companies in the world, Lancaster Laboratories is a global leader in bio/pharmaceutical laboratory services providing innovative and timely scientific solutions to streamline the drug development process.
With facilities in Lancaster, PA, Portage, MI and Dungarvan, County Waterford, Ireland, and a global capacity of over 300,000 square feet, Lancaster Laboratories has the capabilities to meet your global regulatory requirements. All of our facilities offer cGMP-compliant laboratory services and operate under the same strict quality control program and utilize the same LIMS system.
Our clients can choose from five service models, including our award-winning Professional Scientific Staffing℠ and our Full Time Equivalent model to determine the most efficient and cost-effective service solution for their project. We also provide 24-hour data access via our innovative and secure online tool at LabAccess.com℠.