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IPEC  Representatives  Present  Excipient  Workshops  in  Brazil  

Individuals representing IPEC-Americas and IPEC Europe traveled to Brazil August 19 – 21 to participate in a series of workshops at Sindusfarma (IPEC-America’s Industry Partner in Brazil) and ANVISA (Brazil’s Food & Drug Regulatory Agency). The first workshop took place at Sindusfarma’s headquarters in Sao Paulo, Brazil. There were 50 to 55 participants from both the local pharmaceutical industry and from local excipient suppliers. Domestic and multi-national companies were represented.

David Schoneker (left), IPEC-Americas Vice Chair of Maker and Distributor Relations, spoke about the challenges for detecting elemental impurities in excipients and provided an overview of both IPEC’s and the Coalition’s activities to harmonize the USP <232> and ICH Q3D requirements and implementation timelines. He also gave a presentation that discussed the differences between Co-processed Excipients and Simple Mixtures, and what type of data is required to support the safe use of co-processed excipients.

Fernanda Fugii (second from the left) from Colorcon Brazil, acted as a key point person for IPEC-Americas in Brazil to coordinate the workshop with Sindusfarma. The Chair of the IPEC-Americas Good Manufacturing Practices Committee, Ann Van Meter, (center) addressed in her speech the need to globally har-monize the GMP expectations and regulations for pharmaceutical excipients. She also spoke on the NSF-IPEC 363, Atypical Actives, and the draft guideline being de-veloped on Technically Unavoidable Particles. Priscilla Zawislak, chair of IPEC-Americas Compendial Review Committee, (far right) addressed three issues in her lectures: Implications of the U.S. FDASIA legislation for excipients, the new IPEC Certificate of Analysis guide, and the concepts related to Excipient Variability and QbD to increase robustness in product development for pharmaceuticals.

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Sandra Mara (center photo, on the right), from Croda Brazil, represented Iain Moore from IPEC Europe at the workshop. She addressed in her lecture the subject of quality risk management and how this can be used to develop appropriate GMP approaches for the different types of excipients and some of the technical requirements that may exist. The event was coordinated by Jair Calixto (shown on the right in photo below) from Sindusfarma, a key contact for IPEC-Americas’ valuable partnership with Sindusfarma.

A second workshop was held two days later in Brasilia for key people at ANVISA interested in excipients. Approximately 15 to 18 people from ANVISA participated. They represented the following departments: New and Generic Drug Reviewers, Pre and Post Approval (the largest group represented), and API and Excipient Inspection. The program was similar to the Sindusfarma Workshop with the exception that presentations on the New CoA Guideline and the Technically Unavoidable Particles were left out in order to leave enough time for a Q&A session at the end of the Workshop. Both topics were introduced and briefly described.

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There were a number of questions from ANVISA regulators with particular interest given to the formulation flexibility concepts that were presented under the topic of quality by design. The IPEC team discussed the growing interest in developing robust formulations using multiple grades of a particular excipient and the quantitative adjustments of these grades on a batch to batch basis to hit a target profile for a critical material attribute that may be important in a specific drug formulation. This was a new concept for ANVISA and there were a number of questions about how this could be done. The IPEC team mentioned that this is a topic that IPEC-Americas has been discussing with the U.S. FDA during recent QbD workshops IPEC provided to FDA, and that there still needs to be further discussion about the criteria needed for an approach such as this. It was stressed that acceptance of this type of approach will be critical in the future (as it has been done in the food industry, where the composition is not fixed) if we want to improve drug product quality and consistency, since it will not be possible to simply make process adjustments to address all the types of excipient variability which exists. There was positive feedback received from the ANVISA participants, who indicated that they would like additional workshops from IPEC in the future. At the conclusion of the workshop, several individuals from ANVISA mentioned that the Brazilian Excipient GMP Regulations that they have been working on for some time may be published before the end of this year. It also appeared from the conversation that many of the comments that IPEC provided to ANVISA at last year’s workshop (and in writing) have been addressed in the current version of this regulation.