Institute for International Research

Tuesday, June 26th, 2007:

AM Workshop

Residual Solvent Testing Strategies and Regulatory Guidance

 

THIS JUST IN!

 

 

Delayed Implementation for General Chapter <467> Residual Solvents

 

The USP just announced that the General Chapter <467> guidance for residual solvents is now delayed from July 1, 2007, to July 1, 2008. This delay will allow manufacturers additional opportunity to develop the needed analytical capability or to obtain appropriate information from other manufacturers to conform to the standards described in General Chapter <467> Residual Solvents.  DO NOT MISS THIS KEY LEARNING OPPORTUNITY at IIR's Analytical Method Development Strategies conference next week. 

 

 

Ø       Hear Case Studies and Regulatory Guidance from Eli Lilly, Hospira, and IPEC Americas.

 

Ø       Take advantage of the opportunity for open discussion and extensive Q&A among the leading scientists studying and developing Residual Solvent Testing Strategies.

Workshop Agenda:

8:30 Workshop Registration and Morning Coffee

9:00 –9:30 am –General Overview of the Guideline –Eric Sheinin

9:30-10:00 am –IPEC Perspective on Impact to Excipients –Dave Schoneker

10:00-10:30am –Process for determining Residual Solvents on a Single Item –Anne Warner

10:30-11:00 –Break

11:00-11:30am –Dealing with Residual Solvents for a Drug Product –Chris McGinley

11:30 –12:00 –Panel Discussion / Questions with Anne, Eric, Chris and Dave

12:00 Lunch for Morning Workshop Leaders and Participants

Workshop Leaders:
Susan J. Schniepp, Manager, Compendial Compliance, HOSPIRA
Anne M, Warner, PhD, Research Advisor, Analytical Development, ELI LILLY & COMPANY
Christopher McGinley, PhD, HOSPIRA
David R. Schoneker, Director of Global Regulatory Affairs, Colorcon/Chair, IPEC AMERICAS

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PM Workshop

Reduce Testing Difficulties with Strategies for Sample Preparation

12:30 Workshop Registration
1:30 Workshop Begins
2:30 30 Minute Networking and Refreshment Break
4:15 Workshop Concludes

CASE STUDY Strategies for Troubleshooting Low Potency Results in Drug Product HPLC Assays: Is it the Method or the Formulation?

Low potency values are common occurrences in drug product HPLC assays. Considerable time and resources are often committed to determine if the low potencies are method or formulation related. The need for analysts to quickly resolve the method vs. formulation issue is obvious, because critical project timelines/milestones will be affected. Numerous tools, including exotic and non-traditional sample preparation/extraction techniques, are available to help quickly troubleshoot and resolve the method vs. formulation issue. These tools/techniques, when used appropriately, can also lead to increase efficiencies in the method development/validation process and aid in the development of robust/rugged analytical methods for solid oral dosage forms.

• Explore factors Influencing Low Potency Results in Drug Product HPLC Assays
• Utilize strategies for Troubleshooting Low Potency Results in Drug Product HPLC Assays - Case Studies

Develop Rugged and Robust Sample Preparation/Extraction Methods for Solid Oral Dosage Forms

Extraction of the active pharmaceutical ingredient (API) and degradation products is critical to accurately determine the assay and purity of a dosage form. Developing a rugged and robust sample preparation method for solid oral dosage forms can be challenging. In the early stages of development there is limited experience with the API and dosage form. In later stages of development the manufacturing process may change or be scaled up and impact the method's ability to recover the API. In addition, method robustness issues may be encountered as the method is transferred to other laboratories. Common sample preparation/extraction issues and strategies to address these issues will be discussed. Understanding these issues and strategies will lead to the development of rugged and robust sample preparation/extraction methods.

• Understand API and dosage form properties that impact sample preparation/extraction
• Avoid common extraction problems
• Develop rugged and robust sample preparation methods

CASE STUDY Identification of Impurities Formed During Analytical Sample Preparations and Method Development

Impurities or contaminants formed during analytical sample preparations occur frequently and their identifications are quite challenging once the methods are transferred and implemented in QC labs. The potential sources of those impurities should be considered during the method development. This presentation will:

• Explore how you can determine what method to use to ID and separate impurities
  
• Identify how well you need to know the product to predict or understand what will happen in the future
  
• Uncover optimal use of orthogonal methods and ensure correct analyzation

Automating Sample Preparation- How Much More Efficient Can it make your Lab

• Is it worth the effort?
  
• What columns are being used and why?
  
• What new developments are there?
  
• Explore how Automated technology optimizes your method choices

Workshop Leaders:
Carlos W. Lee, PhD, Senior Principle Scientist, PFIZER, INC.

Beverly Nickerson, PhD, Associate Research Fellow, PFIZER, INC.

Peter Zhou, PhD, Senior Principle Scientist, AMGEN

AM Workshop Residual Solvent Testing Strategies and Regulatory Guidance PM Workshop Reduce Testing Difficulties with Strategies for Sample Preparation