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

TERMINAL STERILIZATION VALIDATION SHOULD DEMONSTRATE 10 or better sterility assurance levels, according to a new FDA guideline on NDA/ANDA submission requirements for sterilization process validation. The guideline emphasizes that validation studies for terminal sterilization processes should be submitted in applications demonstrating a 10 sterility assurance level "for all parts of the drug product (including the container and closure, if applicable) which are claimed to be sterile." FDA recognizes that the specific type of study and the methods used to carry out the study or studies "are product and process specific and may vary from manufacturer to manufacturer." However, the guideline states that microbiological challenge studies must demonstrate the 10 efficacy level "under the most difficult to sterilize conditions (e.g., the most difficult to sterilize load with biological indicators at microbiological master sites or in master product or both)." Microbiological master sites or solutions are defined as those "in which it is most difficult to kill the biological indicator under sterilization cycles that stimulate production conditions." The "Guideline for Submitting Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products" was published by FDA in the Dec. 3 Federal Register. Written comments on the guideline should be submitted to the agency by Jan. 3. The document contains separate sections discussing submission requirements on the validation of: moist heat terminal sterilization processes; other terminal sterilization methods including ethylene oxide and radiation; and aseptic fill manufacturing processes. Stability considerations are also addressed. The information contained in the guideline was issued by FDA in preliminary form at a workshop on sterilization process validation sponsored by the agency in Chicago, Ill. in January. Based on the discussions at that conference, FDA issued a revised draft at a follow-up workshop in New Jersey in early June. The agency plans to hold additional workshops on the subject in Europe and California over the next few months. The guideline points out that whether a drug product is sterilized by a terminal sterilization process or by an aseptic filling process, "the efficacy of the sterilization process may be validated without the manufacture of three production batches." However, FDA cautions, "the data should be generated using procedures and conditions that are fully representative and descriptive of the procedures and conditions proposed for manufacture of the product in the application." FDA explains that the scientific evaluation of the validation information submitted in applications "is part of a cooperative effort between the review staff, compliance staff, and field investigators to ensure the overall state of control of the sterile processing" of drug products.

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