Rockville, Md., October 2, 2007 – The United States Pharmacopeial Convention (USP) today announced the award of a specific verification mark, shown at the conclusion of this announcement, to two drug substances (Active Pharmaceutical Ingredients) manufactured by Dr. Reddy’s Laboratories, Ltd. in Hyderabad, India. The two drug substances are Ramipril and Finasteride. Dr. Reddy’s may now use this special mark on its certificate of analyses and other materials to signal to purchasers, regulatory bodies, official medicines control laboratories, independent testing bodies, and others that the two drug substances have undergone a rigorous and independent conformity assessment activity conducted under the auspices of USP’s Pharmaceutical Ingredient Verification Program (PIVP). Dr. Reddy’s was the first manufacturer to enter the USP PIVP. Two more drug substances manufactured by Dr. Reddy’s are in the final stages of verification by USP.
USP’s PIVP is a voluntary program that includes:
- Evaluation of an ingredient manufacturer’s quality systems through an audit for compliance with Good Manufacturing Practices (GMPs, using ICH Q7 as the standard);
- Review of manufacturing and quality control documents;
- Laboratory testing of ingredient samples from USP-selected lots for compliance with a private or public monograph, including those available in the United States Pharmacopeia (USP);
- Request for follow-on information such as post evaluation change in method or manufacturer that might alter the primary decision; and
- Yearly re-evaluation through testing and other approaches.
“USP has verification programs for dietary supplements and dietary supplement ingredients and, based on decisions of its Board of Trustees, expanded these programs last year to include pharmaceutical ingredients, both drug substances and excipients,” said Roger L. Williams, M.D., USP’s executive vice president and CEO. “USP believes these programs are critically needed in a world with many thousands of manufacturers making many thousands of pharmaceutical ingredients.” Dr. Williams said that many of these ingredients seldom if ever receive inspections, even in advanced countries, and many may be substandard or even counterfeit. While USP’s effort is small, Williams noted that it represents a substantial commitment to work with manufacturers who wish to obtain independent documentation of the integrity of their work and the commitment of their employees. Dr. Williams also said that continued vigilance is needed to assure the quality of manufactured ingredients for medicines, even when an ingredient has been verified through USP’s PIVP program. He noted that the PIVP mark is not intended to signal a well-manufactured drug product, which is the responsibility of a dosage form manufacturer working with a responsible regulatory agency.
Satish Reddy, COO and managing director of Dr. Reddy's Laboratories, stated, "This certification from a highly respectable body such as the USP is yet another veracious witness of quality systems that are internalised in the operations at Dr.Reddy’s. We will continue to work closely with USP to expand the coverage of this certification program in Dr. Reddy’s."
USP will provide a special certificate to Dr. Reddy’s at the CPhI trade show in Milan on October 2. The certificate will recognize Ramipril and Finasteride as the first drug substances to earn the USP verification mark for pharmaceutical ingredients.
USP looks forward to partnering with regulatory and compendial bodies around the world in advancing its pharmaceutical ingredients verification program. The conformity assessment activity embodied in USP’s verification programs, including PIVP, not only assists manufacturers but also helps USP update monographs in USP and National Formulary and allied official USP Reference Standards (reference materials). Despite this opportunity, USP separates entirely the standards-setting activities of the Council of Experts from its PIVP and other verification programs to ensure the continued independence and objectivity of its standard-setting processes.
Manufacturers interested in information about the Pharmaceutical Ingredient Verification Program should contact Dr. V. Srini Srinivasan at 301-816-8334 or vs@usp.org. All other questions may be directed to mediarelations@usp.org.
Note to Editors: An electronic version of the “USP Verified” mark is available upon request.
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The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standards-setting organization that advances public health and improves patient safety by ensuring good pharmaceutical care. USP standards, which are recognized worldwide, are developed through a unique process of public involvement by volunteers representing pharmacy, medicine and other healthcare professions, as well as science, academia, government, the pharmaceutical industry and consumer organizations. For more information about USP and its standards-setting activities, visit http://www.usp.org/aboutUSP/media.