3138 10th Street N, Suite 500, Arlington, VA 22201 • Phone: 571-814-3449 E-mail: IPECAMER@ipecamericas.org  

 

 

IPEC-­‐Americas  and  Safybi  present  the  First  Excipient  Workshop  to  Drug  Regulators  (INAME)  in  Argentina  

On August 26, David R. Schoneker, Director Global Regulatory Affairs, Colorcon and IPEC-Americas Vice Chair of Maker and Distributor Relations, presented the first ever excipient workshop to INAME (Argentina’s Drug Regulatory Agency) on behalf of both IPEC-Americas and Safybi (Argentina Association of Industrial Pharmacy and Biochemistry), its partner pharma-ceutical industry trade association in Argentina. This followed similar workshops presented by Mr. Schoneker and other IPEC members in Brazil. Mr. Schoneker was joined by Melina Bisio and Dora Tombari (Safybi Excipients Working Group members) at the INAME (Medicines Regulatory Agency) Headquarters. Approximately 80 people from INAME filled the workshop auditorium (below). The participants represented many different departments from within the regulatory agency (inspectors, reviewers, laboratory analysts, etc.). INAME interest in excipient issues was evidenced by the large turnout.

Dr. Marta Spinetto, Director of INAME, welcomed the attendees and thanked the presenter and Safybi for coordinating the plans. She said excipients are an area that INAME hopes to learn more about. The Head of the Inspection group for INAME (Dr. Rodolfo Mocchetto) also provided some introductory comments and moderated the workshop. INAME is currently working on developing their ideas on how to implement a recent regulation that was written regarding gluten in excipients and drug products. This regulation could

3138 10th Street N, Suite 500, Arlington, VA 22201 • Phone: 571-814-3449 E-mail: IPECAMER@ipecamericas.org  

 

potentially require all batches of drugs and excipients to be tested to show they are gluten free unless a special approval is given by INAME for the presence of a gluten containing excipient. There are many concerns in the industry regarding the specifics of this regulation. Mr. Schoneker provided information concerning how gluten is being handled for foods and drugs in the U.S. and Europe and explained that routine testing such as this is not required anywhere in the world and that it would be unlikely that multi-national companies would institute this type of routine testing. He also shared the recent comments that IPEC-Americas has provided to the U.S. FDA on this topic. Safybi will be following up with INAME on this issue further as INAME determines how they plan to implement this regulation. The support of INAME as well as its valuable partnership with Safybi contributed to the success of this workshop. IPEC-Americas and Safybi will continue their collaboration to develop regulatory concepts for excipients in Argentina. After the workshop, Dr. Mocchetto (INAME) expressed interest in hosting additional workshops in the future when IPEC and Safybi can have representatives in Argentina.

Following are the topics that were presented:

• Introduction of IPEC

• The Changing World for Excipient Supply Chains and the Need for Improved Controls

• Global Regulatory/Legislative Changes related to Excipients

• IPEC Guidelines. How can they be beneficial to Industry and Regulators in Argentina

• Total Excipient Control (TEC)

• Pharmacopeial Harmonization of Excipient Monographs

• Excipient Variability and its Impact on QbD - Excipient Interchangeability

• Excipient Stability – Retest and Expiration Interval Concerns – Global Approaches

• INAME Proposed Regulations regarding Gluten free excipients – medicines