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

PIC/S Guideline Sets Harmonized Approach For Classifying GMP Deficiencies Worldwide

Executive Summary

PIC/S has issued guidance to help member pharmaceutical inspectorates classify good manufacturing practice deficiencies to ensure there is a consistent view across inspectorates as to which deficiencies are “critical” or “major.”

You may also be interested in...



PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications

Draft guidance soon will help the world’s leading pharmaceutical inspectorates align views on which drug GMP deficiencies are considered major – and which are truly critical.

PIC/S explores harmonized approach to classifying GMP deficiencies

The Pharmaceutical Inspection Convention and Co-operation Scheme is looking at possible approaches to harmonizing the classification of good manufacturing practice deficiencies and identify the most common GMP deficiencies noted during inspections1.

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

PS124516

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