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

GMP Compliance Guidances Should Be Increased, Lilly’s Miner Says

Executive Summary

FDA needs to issue more guidances on GMP compliance topics, Lilly Corporate GMP Compliance Leader David Miner, PhD, said

You may also be interested in...



GMP Dispute Resolution Pilot May Build In Delay Before Form 483 Is Issued

FDA's GMP dispute resolution pilot could allow drug inspectors a "short post-inspection delay" prior to issuing a Form 483 manufacturing report

GMP Dispute Resolution Pilot May Build In Delay Before Form 483 Is Issued

FDA's GMP dispute resolution pilot could allow drug inspectors a "short post-inspection delay" prior to issuing a Form 483 manufacturing report

Aseptic processing concept paper

FDA expects to release a "concept paper" on aseptic processing in time for the Pharmaceutical Science Advisory Committee to review it at a meeting tentatively scheduled for Oct. 21-22. Industry has called upon FDA to revise its guidance on aseptic processing (1"The Pink Sheet" April 22, p. 18). FDA's aseptic processing guidance was issued in 1987; the agency is preparing an updated draft guidance it hopes to publish by the end of the year...

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS039705

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