Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FDA CONTENT UNIFORMITY COMPLIANCE GUIDE: TESTING SPECS ARE REQUIRED for non-USP tablets and capsules that contain less than 50 mg of any active ingredient. In a recently issued "Compliance Policy Guide," FDA notes that current GMPs require "the establishment of scientifically sound and adequate specifications to assure" that products not subject to compendial requirements meet their purported standards. "Specifications for content uniformity are required, within this context," the guide states, "for tablets and capsules which contain less than 50 mg of any active ingredient." The requirements can be satisfied for such products, the guide adds, by adopting either USP test specifications, or "sound alternative specifications." The FDA guide also requires content uniformity specifications for relative standard deviation for both compendial and non-compendial products. The relative standard deviation specs are in addition to specifications for individual dosage unit assays. The guide points out that there has been "confusion" among tablet and capsule manufacturers as a result of a recent revision in the USP content uniformity requirements. Manufacturers must now include the relative standard deviation specification in order to limit large variations in test results. While "many firms have been reluctant to incorporate the relative standard deviation specification into their standard operating procedures," FDA notes, the USP monograph requirement must be met for a product to be considered in GMP compliance. FDA said that the requirement for specifications for both individual dosage unit assay and for relative standard deviation are applicable regardless of whether the product in question is subject to an NDA. The guide adds that "if an approved NDA does not currently provide for complete content uniformity testing, or provides specifications that are inconsistent with the USP monograph, the NDA holder must submit a change to provide for such testing."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts