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


Glass Quality Crisis Prompts Multi-Faceted Array of Risk-Based Improvements

This article was originally published in The Gold Sheet

Executive Summary

Drug makers, glass suppliers and FDA officials who attended a recent Parenteral Drug Association glass quality conference made some progress toward understanding why glass-related recalls have surged and what corrective and preventive measures they should apply.

You may also be interested in...

Drug Recalls Soared Again in 2013, Driven by Contamination

FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.

USP and FDA Look to Improve Drug Packaging Standards

FDA and the U.S. Pharmacopeia are looking to improve their standards for drug packaging systems. USP is proposing new test methods for detecting contaminants in plastic packaging systems and has proposed a best practice guide for assessing extractables and leachables, while FDA has announced plans to update its 1999 container closure guidance.

Contamination Issues Drove Drug Recalls to Record Levels in 2011

How contamination, sterility assurance, OOS and other issues caused drug recalls to spike again last year. What happened at Aidapak, H&P, Ben Venue, Hospira, Teva and other manufacturers to set a new record.

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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