The service, originally launched almost six months ago but until yesterday yet to tempt any customers, was created by the USP "in response to increasing concerns throughout the pharmaceutical industry about the quality and consistency of pharmaceutical ingredients."

The program has been designed by USP to help participating firms assure their customers that their manufactured ingredients are produced in accordance with good manufacturing practice (GMP) guidelines and that the participant's quality controls and systems comply with the ingredient label, among other requirements.

On successful participation and completion of the USP program audit, firms are granted permission to use a dedicated logo in conjunction with a certificate of analysis to advertise their successful qualification.

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

The voluntary USP ingredient verification scheme can be used to confirm the quality of active pharmaceutical ingredients (APIs), excipients and raw materials, but does not let firms off the hook when it comes to audits and inspections by other regulatory bodies.

"The USP audit is not a substitute for a regulatory audit, but it will prepare a company for the strictest of regulatory audits," claims the organization.

Companies will still require an US Food and Drug Administration (FDA) audit, but according to the USP this should be "facilitated for an ingredient that has successfully completed all of the requirements of the Pharmaceutical Verification Program."

However, the organization also notes that it will audit sites using the same guidelines as the FDA, and review the same chemistry, manufacturing and control data as the FDA. According to the USP, this will give companies the chance to identify and resolve any issues ahead of an official FDA inspection.

However, the USP does also admit that as "each auditor has a different background and viewpoint, the FDA audit still is likely to find some deficiencies."

If a firm opts for the pharmaceutical ingredient verification scheme, the USP's fee is negotiated and calculated based on anticipated costs documents reviews, laboratory testing and the performance in the GMP audit.

The time it takes a company to achieve verification for its ingredients following an initial proposal depends on how prepared the firm is - according to the USP, a highly prepared participant can expect to receive the Certificate of Standards Compliance five to eight months after the approval of the licence agreement between the two parties.

Once successfully obtained, the USP certification is valid for three years after which a re-verification process will need to be undertaken to ensure continued USP recognition.