Abstract
In the August of 2002, the Consumer Healthcare Products Association (CHPA) member companies were asked to assist the healthcare industry in addressing the lack of stability guidelines that were directly applicable to Over-the-Counter (OTC) monograph drug products. A Stability Working Group (SWG) was formed in May 2003 with experts from the following companies: Johnson & Johnson, Colgate-Palmolive Company, Novartis Consumer Health, Inc., McNeil Consumer Healthcare, Schering- Plough HealthCare Products, Inc., Bayer HealthCare, LLC, Purdue Pharma, The Procter & Gamble Company, Perrigo Company, and a CHPA facilitator. The SWG set out to develop a “white paper” document that would provide a science-based, industry recommended, best practice and minimum requirements for the development of OTC monograph drug products in the United States that are not regulated by an NDA/ANDA.
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