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

PARAMETRIC RELEASE CAN REPLACE END-PRODUCT STERILITY TESTING for terminally heat-sterilized drug products, with an approved supplement for the procedure, according to the explanation of FDA's policy in a compliance policy guide recently released by FDA. Parametric release is defined by FDA as "a sterility release procedure based upon effective control, monitoring, and documentation of a validated sterilization process cycle in lieu of release based upon end-product sterility testing." Before a lot is released, the compliance guide states, "all parameters within the procedure must be met." The requirements for parametric release in lieu of end product sterility testing are described in the compliance guide. The parameters include validation of the sterilization process cycle and of the integrity of the container closure system employed, bioburden testing, and the inclusion of chemical or biological indicators in each truck, tray, or pallet of each sterilizer load. Discussing validation of the sterilization process cycle under parametric release, FDA notes that "failure of more than one critical parameter must result in automatic rejection of the sterilizer load." Where equipment malfunction prevents measurement of one critical cycle parameter, the guide states that biological indicators (BIs) can be used to evaluate cycle lethality. However, FDA notes, "if more than one critical parameter is not met, the batch is considered non-sterile despite BI sterility." The compliance policy guide requires NDA holders to have approved supplements providing for parametric release. The allowance for parametric release was first made by the agency in 1985, the guide notes, when supplemental NDAs covering the procedure were approved for a few large volume parenteral drug products. The guide is available from FDA's Dockets Management Branch, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.

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