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OTC Stability Program for FDA Compliance

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Overview / Abstract:

Who Should Attend?
This course is intended for individuals who have the responsibility for establishing the stability of Over-the-Counter (OTC) drug products. This course will benefit individuals in:
• R&D
• Technical Operations
• Contract Laboratories

RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. With the ICH guidance documents covering New Chemical Entities (NCEs) and their associated drug products, there was no guidance provided for OTC drugs covered by an ANDA or OTC monograph. In 2014, FDA issued Guidance for Stability testing requirements for all drug products covered by an ANDA, but no guidance has been provided for OTC monograph drug products.

As a result, strictly following the ICH stability guidance for NCEs is unwarranted and ignores this significant database of information that is typically available for OTC drug products. For OTC drug products covered by an OTC monograph or an ANDA, there is frequently years of proven experience with the drug substance as well as the drug product. It is this body of data that can often be used to justify a pre-market stability program.

This 2-day intensive course will provide an understanding of how the pre-market stability programs can be successfully managed while minimizing the overall timeline. Lectures will address the seven key GMP aspects of a stability program along with all of the relevant ICH, FDA, WHO and CHPA guidelines that cover drug product stability. Accelerated testing that allows the marketing of a new OTC drug product prior to the generation of long term, real time stability data and confirmation of the stability projections through an appropriate post-market stability program will also be covered.


May 10, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

David E. Wiggins; Analytical/Stability Consultant

Keywords / Search Terms

CfPA OTC Stability Program, FDA, Compliance, ICH, WHO, CHPA, ANDA, GMP Seminar CE CME

LIVE Activity Location Details

05-09-2018 - 05-10-2018

New Brunswick
United States of America

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