IPEC-Americas and IPEC Europe have jointly published a guide for excipient makers and users on co-processed excipients. This guide offers best practice and voluntary guidance on the development, manufacture and use of co-processed excipients and provides support to both manufacturers and users of co-processed excipients.
Co-processed excipient users are responsible for assuring fitness for purpose and that the co-processed excipient and its components are manufactured to acceptable good manufacturing practice (GMP) standards. The guide facilitates communication between excipient users and suppliers regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.
Who Should Attend:
The following employees of CPE excipient makers and users (pharmaceutical companies):
- Regulatory Affairs
- R&D / Technical Service
- Product Safety / Toxicology
CPE Users (Pharmaceutical Companies)
- Regulatory Affairs
- Compendial Affairs
- Safety / Toxicology
- Provide history of co-processed excipients (CPE)
- Discuss the need for a CPE Guide
- Discuss and define single-entity, mixtures/blends, and CPEs
- Are CPEs new or novel?
- Discuss regulatory implications of CPEs
- The Co-processed Excipient Guide organization and content
- List and discuss benefits of the Co-processed Excipient Guide
- Present CPE case study
For the past four years, Mr. Zeleznik has served as Manager of Technical Affairs with MEGGLE USA. In his role, he is responsible for providing formulation and product application guidance as well as having quality and regulatory oversight for MEGGLE USA’s North American lactose manufacture. Prior to joining MEGGLE USA, Mr. Zeleznik was Associate Director, R&D with JRS PHARMA and Research Manager with Penwest Pharmaceuticals Co. Mr. Zeleznik has over 18 years’ experience in the pharmaceutical industry, having specialized in the development and application of high functionality excipients and in particular, co-processing applications for the enhancement of excipient and pharmacologically active ingredients performance. He holds several patents in areas of product and process development, formulation development, and API co-processing. Mr. Zeleznik has authored or co-authored several articles published in various industry journals. He holds a Master’s Degree in Chemistry from the State University of New York.