Active Pharmaceutical Ingredient (API) and Drug Product Specifications

This comprehensive three-day course is valuable to R&D personnel involved with researching synthetic routes, scaling up and manufacturing APIs. Those responsible for achieving technology transfer, as well as, generating CMC data for all regulatory filings from IND to NDA will also benefit from this course. Chemists and chemical engineers in process R&D who perform, supervise, or manage process scale up for the manufacture of pharmaceuticals will find this course valuable.

The course is also important to those in other departments who participate in work surrounding the manufacture and release of APIs. This includes manufacturing chemists preparing API under cGMP protocols for clinical and non-clinical use; formulations personnel converting cGMP API to finished dosage forms; as well as analytical chemists involved with stability testing, assays, methods development and drug release.

Personnel in Regulatory Affairs, Quality Assurance, and the Quality Control laboratories who are involved in cGMP/cGLP activities will also benefit by acquiring an in-depth knowledge of FDA regulations and ICH guidelines.

Learning Objectives

This course provides a comprehensive understanding of operations involved in the manufacture and testing of APIs for non-clinical and clinical use. Diverse facets of parameters involved in determining specifications for Active Pharmaceutical Ingredient (API), raw materials, intermediates, drug products, excipients and placebos will be discussed. Curriculum will outline and detail the issues and guidelines incorporated in FDA guidances and ICH regulatory guidelines. Upon completion of this course, attendees will have a clear understanding of the many factors implicit in chemical route selection and specifications to meet regulatory agency expectations.

Specifically, this course will focus on learning the protocols and techniques needed to establish specifications required to support all levels of development. Attendees are actively engaged through the use of workshops and in-depth discussion, including exercises on writing and revising specifications and the stability data required to support these specifications.

Course Description

This continually updated course covers the entire gamut of operations in the development of a New Chemical Entity (NCE) - from discovery to the filing of a New Drug Application. Emphasis will be placed on discussing stability issues, impurity profiles, polymorphism, bioequivalence, bioavailability and chemical route selection. Upon completion of this course, attendees will have a clear understanding of the many factors implicit in chemical route selection. Participants will also understand the specifications needed to meet current FDA regulatory requirements and ICH guidelines. Selected case studies will be presented to exemplify the concepts covered throughout the course.

View Course Agenda

Past Participants' Comments:

"The Course Director shared real-world examples of projects that worked on the industry. This is a great improvement on many other courses. Too often, course work details regulations and theoretical concepts. This course, however, correctly balanced case studies and regulations within the pharmaceutical industry. The instructor had a great amount of experience in several different dosage forms and in several disciplines within the industry."
Ted R., Supervisor, BI Roxane Inc.

"The Course Director is very knowledgeable about the subject matter and presented it in a very interesting way. Use of course materials and real life examples were very helpful in explaining the concepts and ideas. The casual and interactive nature of the course was great for getting any questions answered and for encouraging the flow of dialogue and information."
Jennifer B., AT Supervisor

"The course was taught phenomenally. Best API training course I have taken. I would highly recommend this to a friend."
Susasha D., RA Associate, Teva/Barr

"This course is very informative and the Course Directors is very experienced and knowledgeable. I would highly recommend this course to anyone involved with specifications."
Syed R., Manager (PD), Incyte Corporation

"This course is very informative. I will be using everything that I learned here for my work, and I learned a lot! Thank you."
Natalya S., Associate Director-RA CMC, Daiichi-Sankyo

Related Courses:

CMC Regulatory Compliance for Biopharmaceuticals and Biologics™

Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries™

Pharmaceutical Production Batch Record Review™

Preparing the CMC Section for NDAs/INDs/CTDs™

Stability Programs for Product Shelf Life – From Development to Approval™

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Active Pharmaceutical Ingredient (API) and Drug Product Specifications™