Medtech Insight 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

GHTF guidance will tackle 'CAPA' acronym

This article was originally published in The Silver Sheet

Executive Summary

The Global Harmonization Task Force's (GHTF) long-awaited guidance document on corrective and preventive action (CAPA) should be ready in draft form by January, FDA GMP/quality systems expert Kim Trautman says ("The Silver Sheet" July 2009). The draft guidance will attempt to avoid using the word CAPA "because it's so misused," she says. The problem with the CAPA acronym is that "people think that you have to perform a preventive action for every corrective action," Trautman told "The Silver Sheet." "This is not true, and does not align with the definition of preventive action and corrective action in ISO 9000," she says. ISO 9000 is the overarching standard for quality management systems in all industries. "We still use ['CAPA'] in the document, but we discuss the problems with the acronym," Trautman notes

You may also be interested in...



US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework

Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.

Abbott Launches Five-Minute POC Rapid COVID-19 Test

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

In A Bizarre Move, Trump Orders GM To Make Ventilators – Even Though The Auto Giant Already Is

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.

Topics

UsernamePublicRestriction

Register

MT036410

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