| dc.description.abstract | After the events of September 11, 2001, the United States enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) to protect the public from terrorist attacks on the U.S. food supply. The Food and Drug Administration (FDA) tightened its regulations on manufacturers, including those of excipients, or processing aids used in many food and pharmaceutical products. One common excipient, glycerin, now faced stricter regulations.
Unfortunately, there was a lack of resources available for excipient manufacturers until recent years. The need for guidance documents became evident as incidents involving counterfeit glycerin were linked to widespread illness and death across the globe. The International Pharmaceutical Excipients Council joined forces with the Pharmaceutical Quality Group and published The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients. IPEC-PQG divides excipient GMP’s into five sections: quality management systems – excipient quality systems, management responsibility, resource management, product realization, and measurement, analysis and improvement.
Company XYZ sells refined glycerin to customers for use in pharmaceutical and food applications; therefore, the site needs to ensure full compliance with excipient GMP’s. Because of the number and depth of topics outlined in IPEC-PQG’s GMP’s, this project will focus on excipient GMP training, management commitment, annual product review, and significant change notification. Recommendations for maintaining compliance in these areas will be shared with Company XYZ. | |
