Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Lilly Official Offers Tips On Reducing Contamination Risks In Cleanrooms

Executive Summary

Having a multilayered approach to sterility assurance is key to preventing contamination in cleanrooms, with equal attention paid to gowning, aseptic technique, engineering technique and proactive and detailed trending, says Eli Lilly official. Official also advises manufacturers to follow both USP Chapter 1116 and the EU’s Annex 1 if they want their sterility assurance programs to pass muster with inspectors and do business globally.

You may also be interested in...



EU Defends Plans To Keep 'PUPSIT' Testing In Revised EU GMP Annex 1

An EU regulatory official is undeterred by pleas from industry to modify a requirement that manufacturers conduct pre-use, post-sterilization integrity testing of filters for sterile drugs under EU GMP Annex 1. The original annex required PUPSIT testing and the revision also is expected to require it. The revised annex has been repeatedly delayed, and now is expected early next year.

Significant Revisions To Annex 1 Cleanroom Standard Soon To Be Released

MHRA inspector and rapporteur Andrew Hopkins anticipates that the long-awaited revision of Annex 1 on environmental monitoring standards for cleanrooms will soon be released and offers a preview of some of the changes.

Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others

Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121710

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

Cancel