Regulatory Open Forum

Hello there,

Is it required to report a deviation for a drug product - not biological - to FDA when there was no affect on the product confirmed after testing?
I understand that as per 21 CFR 211.192, to keep a written record of the event and investigation on-site.

Thanks in advance!
Claire

------------------------------
Claire McMorrow
'S-Gravenhage
Netherlands
------------------------------

This message was posted by a user wishing to remain anonymous

No reporting required unless there is a change to the product either to API or to drug product. Deviations - 21 CFR 211.92 is way to go!
Original Message:
Sent: 14-Jun-2021 09:11
From: Claire McMorrow
Subject: Reporting deviations to FDA

Hello there,

Is it required to report a deviation for a drug product - not biological - to FDA when there was no affect on the product confirmed after testing?
I understand that as per 21 CFR 211.192, to keep a written record of the event and investigation on-site.

Thanks in advance!
Claire

------------------------------
Claire McMorrow
'S-Gravenhage
Netherlands
------------------------------

Thanks!

------------------------------
Claire McMorrow
'S-Gravenhage
Netherlands
------------------------------

Original Message:
Sent: 14-Jun-2021 12:02
From: Anonymous Member
Subject: Reporting deviations to FDA

This message was posted by a user wishing to remain anonymous

No reporting required unless there is a change to the product either to API or to drug product. Deviations - 21 CFR 211.92 is way to go!
Original Message:
Sent: 14-Jun-2021 09:11
From: Claire McMorrow
Subject: Reporting deviations to FDA

Hello there,

Is it required to report a deviation for a drug product - not biological - to FDA when there was no affect on the product confirmed after testing?
I understand that as per 21 CFR 211.192, to keep a written record of the event and investigation on-site.

Thanks in advance!
Claire

------------------------------
Claire McMorrow
'S-Gravenhage
Netherlands
------------------------------

The ramifications of the term "deviation" need to be fully considered.  Please take note of the requirements for a Field Alert Report (FAR).  There is an extremely rigorous timeframe of 3 working days to report (identify) drug products in distribution that represent a potential health hazard (see 21 CFR 314.81) and FDA's corresponding Compliance Program 7356.021.  If a potential health hazard (such as a failing stability test result) cannot be legitimately discounted (invalidated) within 3 working days, an initial field alert is expected to be filed.  A supplemental report can then be filed to amend the record.

There is a separate regulatory requirement for Biological Product Deviation Reports.

------------------------------
Mark Lookabaugh
Principal
Mark Lookabaugh Consulting, LLC
Stafford Springs CT
United States
Principal ConsultantPrincipal Consultant1lookabaugh@cox.net
------------------------------

Original Message:
Sent: 15-Jun-2021 02:36
From: Claire McMorrow
Subject: Reporting deviations to FDA

Thanks!

------------------------------
Claire McMorrow
'S-Gravenhage
Netherlands

Original Message:
Sent: 14-Jun-2021 12:02
From: Anonymous Member
Subject: Reporting deviations to FDA

This message was posted by a user wishing to remain anonymous

No reporting required unless there is a change to the product either to API or to drug product. Deviations - 21 CFR 211.92 is way to go!
Original Message:
Sent: 14-Jun-2021 09:11
From: Claire McMorrow
Subject: Reporting deviations to FDA

Hello there,

Is it required to report a deviation for a drug product - not biological - to FDA when there was no affect on the product confirmed after testing?
I understand that as per 21 CFR 211.192, to keep a written record of the event and investigation on-site.

Thanks in advance!
Claire

------------------------------
Claire McMorrow
'S-Gravenhage
Netherlands
------------------------------