APR Nov/Dec 2022 - 53

« MANUFACTURING
The inability to inspect " remove[d] a critical
source of information about the quality of
drugs manufactured for the U.S. market, "
which raised warning bells.17
In particular,
members of Congress sent a letter to thenacting
FDA Commissioner Janet Woodcock
with questions about FDA's efforts to
" mitigate the backlog of [...] inspections. " 18
Congress expressed " concern[...] that more
than one year into the pandemic, the strategy
for resuming all inspections and addressing
the backlog of delayed inspections remains
unclear. " 19
The letter pressed FDA to resume
onsite inspections and make improvements
to its current inspectional techniques due to
the extended time between inspections to
" ensure patient access to safe and effective
medicines. " 20
Relatedly, FDA has also
faced pressure from industry for increased
inspections to ensure the continuous supply
of necessary drugs in the United States.21
FDA's New Inspectional
Approach
and Techniques
In order to decrease the backlog of
inspections
and
bolster
assessments
of
foreign manufacturers, beginning in 2021,
FDA modified its approach to inspections
in three key ways: (1) conducting remote
assessments, (2) sharing and relying upon
information from international regulatory
bodies, and (3) initiating unannounced
inspections for foreign manufacturers.22
First, to continue its inspections during the
pandemic, FDA piloted and increasingly
relied on remote regulatory assessments
(RRAs), which are reviews of records and
other information submitted upon request
from FDA.23
The reviews are conducted
entirely remotely, and the agency has
frequently requested and assessed
documents remotely during the COVID-19
pandemic. Records requests are mandatory
since FDA is statutorily authorized to review
documents remotely in advance or in lieu
of onsite inspections.24
Only establishments
engaged in the manufacture, preparation,
propagation, compounding, processing,
or importation of a drug may be subject
to mandatory RRAs. FDA also unveiled
www.americanpharmaceuticalreview.com |
| 53
non-mandatory or voluntary assessments
such as remote interactive evaluations
using technologies such as livestreaming
of video operations, teleconferences, and
screensharing.25
FDA plans to use these
remote interactive evaluations to " verify
corrective actions taken in response
to inspections of previously compliant
manufacturers and in gaining compliance
insight. " 26
The agency's recent draft guidance
on RRAs provides helpful context for how it
will conduct records reviews and remote
interactive evaluations going
forward,
and notes the types of records that could
be requested. These include test results,
deviation and non-conformance
reports,
A pack size for
your application.
Whatever your application,
we can supply you with a pack
size for successful testing. And with
no further preparation needed,
you save on time and waste.
Our high-quality ISO 17025 and
17034 products come with extensive
Certificates of Analysis containing
measurement uncertainty values
and can be used with pharmacopoeial
methods and beyond.
lgcstandards.com/mikromol
mikromol@lgcgroup.com
»
http://www.lgcstandards.com/mikromol http://www.americanpharmaceuticalreview.com
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
