Dr. Reddy’s Laboratories, a generic drug manufacturer in Hyderabad, India, has signed on as the first participant in the U.S. Pharmacopeia’s Pharmaceutical Ingredient Verification Program.
The USP created the program in response to increasing concerns throughout the drug 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.
The company will submit ingredients to the USP’s verification process, which includes the following steps:
- evaluating the quality systems of ingredient manufacturers through an audit for compliance with Good Manufacturing Practices
- reviewing manufacturing and quality-control documents for the ingredients
- laboratory testing of ingredient samples from USP-selected lots to ensure compliance with the USP’s FDA-enforceable standards for purity, potency, and quality
- surveillance testing of ingredients bearing the USP Verified mark after the verification process
After each ingredient or excipient is verified, Dr. Reddy’s will receive a Certificate of Standards Compliance. The company may then post the Verified mark on the shipping container and the certificate of analysis demonstrating that it has met the USP’s quality standards.
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The USP is named in U.S. federal law, and compliance with its standards is enforceable for drugs and dietary supplements marketed in the U.S. USP standards are also recognized worldwide.