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

UsernamePublicRestriction
UsernamePublicRestriction

Quality Lowdown: FDA Defends Nitrosamine Testing Methods While US, EU Enforcement Continues

Executive Summary

The crisis of nitrosamine contamination in prescription drug products continues to roil the world’s health authorities and prompts debate on the different approaches used to measure these impurities. Meanwhile, an Austrian firm gets inspected despite the pandemic and yet another homeopathic firm gets an FDA warning letter.

You may also be interested in...



The Quality Lowdown: Yes, The US FDA Expects You To Heed Import Alerts And Testing Requirements

PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.

2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters

The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.

USP Proposes Analytical Methods For Drug Makers To Detect Nitrosamine Impurities

The USP has launched an initiative to address the nitrosamine crisis by proposing a new general chapter that outlines a set of analytical methods that manufacturers can use to demonstrate their products are free from unsafe levels of these potential carcinogens. The chapter is aligned with the FDA’s guidance on nitrosamine impurities.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS142568

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