Course Description

Excipients: Compliance with Compendial and GMP Requirements | A 12 Hour On Demand Course

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Course ID 2795

In-Person Course

Who Should Attend?
This course is intended for those responsible for ensuring compliance of excipients with the pharmacopoeias and regulatory authorities, and is applicable to pharmaceutical and excipient manufacturers and excipient distributors within the OTC, generic, innovator, biotechnology, consumer-care, and related industries. This course will benefit individuals in:
  • Compendial affairs
  • Regulatory affairs/CMC
  • Quality assurance/Quality control
  • Analytical chemistry
  • R&D/product development/Formulation/Method development
  • Product management/marketing

In addition, those individuals who perform analysis using Compendial standards would benefit from a better understanding of how the different compendia are structured, revised and interface with GMP requirements.

Co-sponsored by IPEC-Americas

and The Center for Professional Advancement (CfPA); partners in training and education (T&E)

IPEC member?
Please contact for special member rate and details.

Course Description
Excipients often play a critical role in the manufacture of biopharmaceuticals and in the formulation of small molecule and biopharmaceutical products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States Pharmacopeia-National Formulary (USP-NF), states: “Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.”

Compliance with compendial requirements is a legal and regulatory requirement in those countries in which a pharmacopoeia is specified. While there is good awareness of compendial requirements for drug products and APIs, there is less understanding by excipient manufacturers related to confirmation the excipient meets the pharmacopoeia monograph.

This comprehensive 2-day course includes an introduction to the pharmacopoeias, with an emphasis on the USP-NF and Ph. Eur. A global perspective which touches on other pharmacopeias is presented. Details of the content, organization and use of the pharmacopoeias are covered, along with regulatory considerations for excipients. The course reviews practical examples of compliance with compendial requirements, as published by pharmacopoeias. In addition, there is exploration of the development and revision processes for compendial monographs with real-life case studies, along with a review of efforts toward compendial harmonization by IPEC, the Pharmacopoeial Discussion Group (PDG), and the International Council for Harmonisation (ICH). The course concludes with an exploration of approaches to compendial surveillance, opportunities for advocacy, and ultimately, compliance with the requirements in the pharmacopoeias.

The course will assist the global bio/pharmaceutical industry; including innovator, generic, biotechnology, Contract Manufacturer, and consumer-care companies, seeking greater understanding of compliance requirements for excipient suppliers, particularly with the USP-NF and Ph. Eur.

Course Director
Irwin Silverstein, Ph.D.; Consultant and Excipient Guidelines and Standards Expert

Irwin Silverstein has been a consultant to the pharmaceutical industry since 2000. His career included 17 years as the head of corporate quality for ISP, a specialty chemical manufacturer that produced excipients and Active Pharmaceutical Ingredients. Since leaving ISP, he works as a consultant. He has been a subcontractor to a consulting firm hired as expert consultants by pharmaceutical firms in consent decree with FDA. Currently, he has continued to work with the International Pharmaceutical Excipients Council of the Americas (IPEC) since their founding in 1991and has been involved in the development of excipient GMPs and related guidelines. He is on the NSF Standards Writing Committee that developed the NSF/IPEC/ANSI 363 Good Manufacturing Practices for Pharmaceutical Excipients ANSI standard. He is also the chair of the IPEC Learning Lab with responsibility for development of workshops, webinars and eLearning.

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Course Director
J. Mark Wiggins; B.S., M.S.

J. Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He is also Pharmacopoeia Editor for the on-line publication International Pharmaceutical Quality. He was previously Director of Compendial Affairs at Merck & Co., Inc., (known as MSD outside the US and Canada), with more than 15 years’ experience optimizing the processes for review and response to compendial changes from around the world to enable quality and regulatory compliance. Mr. Wiggins has been an active participant in compendial harmonization, represented PhRMA on ICH Q4B, authored several papers, and was an invited speaker at international meetings with pharmacopoeias and regulators in the US, UK, Europe, India, Japan, Korea, and China.

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