Significant revisions to standards for residual solvents found in General Chapter <467> of the United States Pharmacopeia–National Formulary (USP–NF) became official on July 1, 2008.
These changes have significant impact for the industry.
In order to clarify this new regulation, SGS is pleased to sponsor a one-day lecture course based on practical applications and focused on implementation issues in the lab. This course will be presented by Dr L. Valentin Feyns, Scientific Fellow, USP and Benoit Rime - International Account Manager – Europe, USP.
Program: (Delivered in English)
8h00 Welcome of Participants
8h30 History of the Residual Solvents Approach
- USP documentary standards, definition, ICH Q3C and EP, OVI in <467>, USP 30 Second Supplement, change in implementation date
9h00 Scope and Contents of the Guideline
- Main points in <467>, Risk-based solvent classes 1, 2, and 3, options for determining levels of Class 2 residual solvents in drug products, approaches for other or new residual solvents
9h30 Analytical Procedure
- Identification, control, and quantitation of residual solvents, rationale for using procedures A and B, methods for procedures A, B, and C, decision tree
10h45 Coffee Break
11h00 Regulatory Aspects
- Code of Federal Regulations, manufacturer-supplier relationship, FDA’s position for industry
11h30 Comparison of USP and EP
- Definition, approaches, Chromatographic systems, preparations, system suitability requirements, information in USP but not EP, information in EP but not USP, similarities
13h45 Development and Validation of Alternative Method
- Development of alternative methods
- Validation of alternative methods: What is validation?
- Test categories, accuracy, precision, specificity/selectivity, detection and quantitation limits, determination of linearity and range
- Verification of method: General Chapter <1226>, system suitability, <621> adjustments
16h30 Questions/Debate Key
Review guidelines contained in Chapter <467> Discuss common mistakes and misconceptions Illustrate Options 1 and 2, as well as procedures A, B, and C Introduce risk-based strategy concept when dealing with compliance issues Explain how to develop and validate alternative methods Locations:
The one-day course will be offered at two different venues:
- 26th of January 2009 in Lyon
- 28th of January 2009 in Paris
Fee for one day lecture course is 650 € per person. (Full payment must accompany the registration form before it can be processed.)
Reserve Your Place:
To reserve your place, complete the registration form before the 21st of January 2009 and submit electronically.
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 56,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.