Not that I'm aware of - the regulatory expectation is that a manufacturer will continue to follow their Quality Management System (i.e., operate within GMP requirements). If remote internal audits are going to be adopted, appropriate changes in the QMS may be needed (e.g., updating SOPs). Continuing with an internal audit program, using some new auditing methods, is likely to be helpful in identifying new compliance issues under the altered operating models related to COVID.
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Tammy Pelnik, MS, IRCA Principal QMS Auditor
President
St. Vrain Group
Boulder CO
United States
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Original Message:
Sent: 08-Jul-2020 13:59
From: Anonymous Member
Subject: Ask Me Anything Session: The Shifting Global Regulatory Landscape
This message was posted by a user wishing to remain anonymous
@Tammy Pelnik Have there been any statements from regulators regarding relaxing audit requirements for "non-essential" manufacturers that have most non-production staff working remotely?
Original Message:
Sent: 01-Jul-2020 12:05
From: Annie O'Brien
Subject: Ask Me Anything Session: The Shifting Global Regulatory Landscape
Hi RegEx members,
Recently, RAPS released its' Quarterly Regulatory Focus Article Series, The Shifting Global Regulatory Landscape. We will be hosting an "Ask Me Anything" session on Wednesday, 8 July, from 1:30-2:30 PM ET here on RegEx. We will have three regulatory experts, @Jordanna Jayne, @Tammy Pelnik, @Darin Oppenheimer, and @Siegfried Schmitt, who will be discussing the articles in real-time and available to answer your questions.
If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event.
Looking forward to seeing your questions!
Best,
Annie
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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
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