Bethesda, Md., July 21, 2016 – The Parenteral Drug Association (PDA) invites pharmaceutical professionals and regulatory officials to participate in a 2-day, experienced-based training course on the application of good manufacturing practices (GMPs) regulations to active pharmaceutical ingredients (APIs) production in San Juan, Puerto Rico, August 8-9. The course is part of an ongoing series of workshops on the topic GMPs for APIs cosponsored by PDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which has included similar events last year in South Korea, Brazil and India.
Regulators representing the following countries/agencies will be attending the training: Argentina’s INAME-ANMAT, Croatia’s Agency for Medicinal Products and Medical Devices (HALMED), Poland’s Main Pharmaceutical Inspectorate, Republic of Slovenia’s Agency for Medicinal Products and Medicinal Devices, Tunisia’s Ministry of Public Health, Taiwan’s FDA, and others.
The U.S. FDA is heavily represented on the podium, with speakers from both the local Puerto Rico Field Office and the Agency’s headquarters in Silver Spring, Maryland.
The focus of the two-day event is the International Conference on Harmonization (ICH) quality guideline on GMPs for APIs, referred to as ICH Q7. This document is the worldwide standard for manufacturers of active ingredients for the pharmaceutical industry.
Interested members of the press can request a “press pass”.