Click on a committee name to review it's 2009 accomplishments and goals for 2010.

Compendial Review Committee

Good Manufacturing Practices

Quality by Design/Product Development

Regulatory Affairs

Safety Committee

Excipient Qualification

Committee: Compendial Review

Chair: Priscilla Zawislak

2009 Accomplishments:
· Monograph revisions in progress were: propylene glycol, glycerin, sorbitol, CMC, HPC and cellulose derivative assay method, HEC, crospovidone, silicon dioxide, sodium starch glycolate, metal impurities, residual solvents, microbiology,
· Members participated in USP and FDA workshops on metal impurities

2010 Goals:
· Achieve harmonization of excipient monographs and general chapters published by USP/NF, EP and JP. 
· Work with counterpart committees from regional IPEC Federation members and IPEC-Pharmaceutical Discussion Group (PDG) in harmonization process
· Significant monographs & chapters for 2010 include: metal impurities, residual solvents, viscosity, cellulose derivatives, glycerin/sorbitol, sodium starch glycolate and glucose

Committee: Good Manufacturing Practices

Chair: Dale Carter

2009 Accomplishments:
· Completed Draft of Stability Guide
· Provided Comments on ISO GMP Annex
· Started Sub-Committee on Validation
· Rejected Eu GDP Audit Guide that was based on ESAD audit

2010 Goals:
· Publish Stability Guide
· Publish GDP Audit Guide based solely on IPEC GDP Guide
· Provide input to NSF representatives
· Provide input to USP GDP <1197> representatives
· Provide comments on ISO GMP Annex
· Provide comments on ISO GDP Annex
· Provide comments on Classification Guide
· Start Revision of IPEC PQG GMP guide

Committee: Quality by Design/Product Development

Chair: Brian A.C. Carlin, Ph.D.

2009 Accomplishments:
· Responded to USP's co-processed excipient monograph proposal
· Issued a position paper on a need for QbD formulation flexibility
· Begin development of a future IPEC Co-Processed Excipient Guide

2010 Goals:
· Continue progress on IPEC co-processed excipient guidance through FDA, USP and industry members
· Development of a response to the USP draft general chapter on excipient performance

Committee: Regulatory Affairs

Chair: Eunice M. Cuirle

2009 Accomplishments:
· Began development of an updated IPEC-Americas excipient master file guide for drug components subject to a Type IV Excipient Drug Master File (DMF)
2010 Goals:
· Completion of a revised and updated IPEC-Americas Excipient Master File Guide
· Develop a summary compilation of existing international excipient drug master file guidance or applicable regulations

Committee Name: Safety

Chair: Chris DeMerlis

2009 Accomplishments:
· Completion of Review of several new excipients by the IPEC New Excipient Evaluation Committee
· Completed Symposium on new excipient safety evaluation for American College of Toxicology annual meeting
· Completed Webinar IPEC New Excipient Evaluation Procedure
· Published article Pharmaceutical Technology publication on the IPEC New Excipient Safety Evaluation Procedure
· Obtained 2 members for Safety Committee (ISP, Pfizer)

2010 Goals:
· Publish article Excipient Safety Symposium American College of Toxicology Journal from annual meeting
· Complete IPEC position paper supporting genotoxicity paper by Dr. Brusick
· Presentation at ExcipientFest IPEC New Excipient Safety Evaluation Procedure May Puerto Rico
· Conduct Webinar IPEC New Excipient Safety Evaluation Procedure (May)
· Publicize IPEC New Excipient Safery Evaluation Procedure
· Obtain members for IPEC Safety Committee

Committee Name: Excipient Qualification

Chair: David Klug

2009 Accomplishments:
· Excipient Information Package (EIP): Template and User Guide, 5/2009
· IPEC Americas and Europe Excipient Pedigree Position Paper, 1/2009
· Qualification of Excipients for Use in Pharmaceuticals, Chimica Oggi / CHEMISTRY TODAY - vol 27 n 5 - September/October 2009 - Focus on Excipients
· Quality Agreement Guide and Template, 6/2009

2010 Goals:
· CoA Guide – revise to update and create Federation Guide
· Glossary – create harmonized glossary and publish to website
· Identify best practices in the excipient industry to assure supply chain security and to develop a guide to share those practices
· Promote Quality Agreement Template
· Significant Change Guide – revise to create Federation Guide