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USP Announces First Participant in Pharmaceutical Ingredient Verification Program

PharmaManufacturing.com
04/17/2007

The United States Pharmacopeia (USP) on Apr. 17 announced that Dr. Reddy's Laboratories, one of the world's leading generic drug manufacturers located in Hyderabad, India, has signed on as the first participant in USP's Pharmaceutical Ingredient Verification Program.

"Participating in this program shows that Dr. Reddy's Laboratories shares USP's commitment to good pharmaceutical care throughout the world,” said Dr. Roger Williams, chief executive officer and executive vice president of USP.

"We look forward to participating in this program so that we can show manufacturers, regulatory authorities and consumers our dedication to producing pharmaceutical ingredients and excipients that are of consistently high quality,” said Mr. Satish Reddy, chief operating officer and managing director of Dr. Reddy's Laboratories.

USP created the Pharmaceutical Ingredient Verification Program in response to increasing concerns throughout the pharmaceutical industry about the quality and consistency of pharmaceutical ingredients. The program enables manufacturers to show the quality and integrity of their ingredients with a recognizable "USP Verified” mark.

As a participant in the Pharmaceutical Ingredient Verification Program, Dr. Reddy's will submit ingredients to USP's verification process, which includes:

• Evaluation of an ingredient manufacturer's quality systems through an audit for compliance with Good Manufacturing Practices (GMPs)
• Review of manufacturing and quality control documents for the ingredients
• Laboratory testing of ingredient samples from USP-selected lots for compliance with USP's FDA-enforceable standards for purity, potency and quality
• Post-verification surveillance testing of ingredients bearing the USP Verified mark

Once each ingredient or excipient passes the verification process, Dr. Reddy's will receive a Certificate of Standards Compliance. They will then be permitted to post the "USP Verified” mark on the shipping container, and certificate of analysis demonstrating that it meets USP's world class quality standards.

USP is named in U.S. federal law and compliance with its standards is enforceable for drugs and dietary supplements marketed in the United States. USP standards are also recognized worldwide. USP offers verification programs for dietary supplements and dietary supplement ingredients, as well as pharmaceutical ingredients.

For more information on the Pharmaceutical Ingredient Verification Program please click here: www.pharmamanufacturing.com/articles/2006/237.html.