NSF International Reference Standards Director of Scientific and Regulatory Compliance Tom Savage will speak at CPHi India regarding quality control testing of active pharmaceutical ingredients and drug dosage forms to US and European standards for quality.
To gain entry into US and European markets, Indian pharmaceutical manufacturers must meet various regulatory requirements. This presentation will discuss how NSF Reference Standards enable pharmaceutical manufacturers to demonstrate the quality and purity of their products and compliance to US and European regulatory requirements, helping Indian pharmaceutical manufacturers gain entry into new export markets worldwide.
WHO: NSF International Reference Standards Director of Scientific and Regulatory Compliance
Tom Savage has more than 35 years of experience with the US Food and Drug Administration (FDA). His expertise includes performing inspections of pharmaceutical facilities worldwide and training FDA analysts on laboratory Good Manufacturing Practices. Tom also initiated and managed the testing of USP reference standard candidates by FDA laboratories throughout the US. Tom served in a variety of roles at the FDA: Senior Policy Advisor for the FDA Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs; Senior Coordinator for Pharmaceutical Sciences in the FDA Division of Field Sciences; and Supervisory Chemist for the FDA Seattle District Laboratory.
As Director of Scientific and Regulatory Compliance for NSF International’s Reference Standards program, Tom Savage manages the laboratory qualification testing of NSF Reference Standard candidates and ensures the Certificate of Analysis package provided with each NSF reference standard meets regulatory requirements worldwide.
WHY: The Indian pharmaceutical industry is the world's third largest by volume. Worldwide exportation requires that pharmaceutical products meet the regulatory expectations of the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory agencies worldwide. These expectations include proper characterization of reference standards used for quality control testing of active pharmaceutical ingredients and drug dosage forms. This presentation will explain how NSF reference standards meet not only the standards of quality expected by the Indian pharmaceutical industry, but also the requirements of regulatory agencies worldwide.
Completely traceable to both US and European pharmacopeial standards, NSF Reference Standards are:
- Tested independently by a minimum of three collaborating laboratories
- Traceable to both United States Pharmacopeia® (USP) and European Pharmacopeia (EP) reference standards
- Verified to conform to U.S. Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) regulatory requirements
- Produced and tested following the principles of current Good Manufacturing Practices (cGMPs)
- Accompanied by documentation that includes a Certificate of Analysis and Material Safety Data Sheet
WHEN/WHERE: Wednesday, November 30 at 15:00 hours (3:00 PM) IST.
CPHi India, Bombay Exhibition Centre, Mumbai, India.
NSF International will also be exhibiting at Booth Q12.
Background on CPHi India 2011: Focused on pharmaceutical ingredients, CPhI India features high level speakers from respected companies covering a range of key topics and trends pertinent to the Indian and South Asian pharmaceuticals markets including: Global Clinical Trials; Global Biosimilars Regulations; Healthcare and OTC Drugs; Developing Difficult Generics; Export Potential; and Competitive API Strategies. Visit cphi-india.com for more information.
About NSF International: NSF International is an independent organization that writes standards and certifies products for food, water and consumer goods to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF operates in more than 150 countries and is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.