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

QRM Not the Same as Root Cause Analysis

This article was originally published in The Gold Sheet

Executive Summary

William Miele of Pfizer Global Manufacturing discussed the differences between quality risk management as espoused under the ICH Q9 guideline and root cause analysis at the 11 APIC/CEFIC European conference on APIs Oct. 23 in Paris. He said that "root cause analysis is retrospective, examining what has already occurred to determine what happened, why it happened and how it can be prevented from happening again. Risk management looks at the dataset and what are the potential future consequences and identifies potential risks and analyzes potentials risks; these actions are all focused on making decisions related to potential future events." He also noted that QRM "is a tool to complement existing works processes" and that "the primary outputs of QRM are decisions to identify the actions needed to controls risk.

You may also be interested in...



FDA Wants To Put Hep C Tests On 510(k) Pathway

The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.

Facing Shortage, FDA Further Relaxes Face Mask, Face Shield And Respirator Guidance

As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers

Why US FDA Requested Ranitidine Withdrawal, And How Other Drugs Could Follow

FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.

UsernamePublicRestriction

Register

PS000313

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

Cancel