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The USP Verified Pharmaceutical Ingredients mark can appear on the shipping containers of pharmaceutical ingredients or excipients certified by USP.

As part of its new service to verify the quality of pharmaceutical ingredients, The United States Pharmacopeia (USP) will also be evaluating packaging for these ingredients as part of its review of the chemistry, manufacturing, and controls (CMC) information provided by participants in the program. USP is offering this service to manufacturers of drug substances and excipients worldwide. The verification service will identify those pharmaceutical ingredients that meet USP’s world-class quality standards as outlined in its Drug Substance Ingredient Verification manual, the group reports.

USP Verified pharmaceutical ingredients will receive a Certificate of Standards Compliance. USP will award the certificate and the right to include a representative mark on each container to drug substances and excipients that pass a rigorous audit, testing, and review process.

USP reports that the process includes the following:

• Evaluation of an ingredient manufacturer’s quality systems through an audit for compliance with Good Manufacturing Practices (GMPs) following the ICH Q7 Guideline for drug substances and the IPEC/PQG Guide for excipients.
• Review of manufacturing and quality control documents for drug ingredients submitted for verification.
• Laboratory testing of ingredient samples from USP randomly 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.

USP auditors will review packaging factors during preaudit documentation review, on-site audit, and receipt of samples in a USP laboratory for testing. USP’s Drug Substance Ingredient Verification will be guiding these auditors.

Once ingredients are certified, participants can communicate ingredient or excipient compliance by displaying the USP Verified Pharmaceutical Ingredients mark on product shipping containers.

Roger L. Williams, M.D., USP’s executive vice president and CEO, announced the new service, saying: “USP is proud to offer this new service. It will assure drug product manufacturers and regulatory agencies that the substances with the USP Verified mark have met the highest standards in the world for strength, quality, and purity. USP wants to raise the quality of medicines by calling attention to the best ingredients. Drug product manufacturers and patients worldwide will benefit as a result.”

USP standards are named in federal law, and compliance with its standards is enforceable for drugs marketed in or exported to the United States. USP also offers verification programs for dietary supplement ingredients and products.

Manufacturers seeking USP Verification for a pharmaceutical ingredient should contact Vijayaraghavan Srinivasan, PhD, USP’s vice president, Verification Programs, at 301/816-8334 or e-mail him at vs@usp.org. All other questions may be directed to mediarelations@usp.org.

USP’s Drug Substance Ingredient Verification manual is available at www.usp.org/USPVerified/pharmaceuticalIngredients/. For more information about USP and its standards-setting activities, visit http://www.usp.org/aboutUSP/media.