38 BioPharm International eBook March 2021 www.biopharminternational.com
nificantly underestimated or not
considered:
• Requirements related to stan-
dard operating procedure (SOP)
development
• Training
• New responsibilities
• Reorganizational aspects
• Addition of staff
• Updated job descriptions
• Signatory aspects of protocols,
SOPs, etc.
• Revision of contracts
• Cost of adding requirements for
accreditation of animal facilities
• Amending reports to change
archive location.
The WG concluded that the pro-
posed regulations may limit the
number of companies that will be
able to execute nonclinical studies in
a compliant manner because of cost.
Dilution of the role of the study direc-
tor and introduction of new roles. The
role of the study director, the sin-
gle point of study control, has been
diluted and responsibilities dupli-
cated with other personnel. New
roles, as proposed, add more organi-
zational complexity, which directs
an overreach in some responsibili-
ties (e.g., management with execu-
tive responsibility). New signatory
requirements could unnecessarily
delay initiation, execution, and
reporting of nonclinical regulated
studies.
Inclusion of the Animal Welfare Act
and Regulations. Animal Welfare Act
and Regulations should be excluded
from the modernized GLP regu-
lations. Animal welfare activities
already are covered by the Animal
Welfare Act and are governed by US
Department of Agriculture (USDA);
and their inclusion in the proposed
rule changes will not advance a
purpose distinct from USDA regula-
tions already in place.
Changing the traditional, independent
role of the QAU. The proposal for FDA
to extend their authority to inspect
all QAU records "when necessary"
to ensure compliance will nega-
tively impact the interrelationship
between management, study direc-
tor, principal investigator, and QAU.
Introduction of additional roles and
responsibilities to align with the qual-
ity systems approach. The proposed
regulations are overly prescriptive
regarding company infrastructure to
support study conduct rather than
providing a flexible framework to
allow large and small organizations
to design and conduct GLP studies.
ADDITIONAL DIALOGUE
WITH INDUSTRY NEEDED
Compliance with FDA regulations
in the conduct of nonclinical labo-
ratory studies is an important pro-
cess that helps ensure the quality
and integrity of data derived from
safety studies, the protection of
human subjects, and marketing
decisions based on accurate and
reliable data. The 2016 proposed
rule changes, as written, did not
provide an improved framework
for moder nization that offered
pharmaceutical companies flexibil-
ity, and did not help improve the
quality, planning, conducting, and
reporting of nonclinical laboratory
studies.
Because of the importance of
these regulations to industry, IQ
GLP LG in January 2017 requested
FDA withdraw the 2016 proposed
rules and open a dialogue with
industry representatives for review
and comment before revised the
proposed GLP regulations becomes
final. FDA to date has not issued a
revision to the GLP regulations.
SUMMARY
The consolidated quality exper-
tise offered by the working groups
of IQ allow the organization to
avoid redu nda nc ies of ef for ts;
benefit from the experience and
expertise of different disciplines
to enable innovative drug devel-
opment approaches that are com-
pliant and meet global qualit y
re qu i re me nt s; a nd prov ide a n
avenue to interact with regulators
to positively influence guidance
documents and implementation of
novel approaches. The QCC was
key in initiating the creation of the
Regulatory Advisory Committee,
which provides expert advice to
any IQ team that needs guidance
in developing justifications for
pro-active engagement with regu-
lators in seeking scientific advice.
REFERENCES
1. J. Lippke, et al., Pharm Tech 44 (8) 51–54
(August 2020).
2. MHRA, GXP Data Integrity Guidance and
Definitions (London, UK, March 2018)
3. FDA, Data Integrity and Compliance with
Drug cGMP–Questions and Answers
(Rockville, MD, December 2018)
4. IQ Consortium, "IQ Data Integrity WG Risk
Assessment Tool," www.iqconsortium.org,
Aug. 3, 2020.
5. FDA, "Good Laboratory Practice for
Nonclinical Laboratory Studies," Notice,
Federal Register, 81 FR 58341, 58341-
58380.
BP
ABOUT THE AUTHORS
Ganapathy Mohan*, Ganapathy_
mohan@merck.com, is executive
director, global quality compliance,
Merck & Co., Inc., Kenilworth, NJ,
USA; Christopher Turner is associ-
ate director, quality laboratory prac-
tices, Bristol Myers Squibb; Dennis
O'Connor is senior associate director,
GMP QA, Boehringer Ingelheim; Lisa
Fink is senior quality technical con-
sultant (retired), Baxter Healthcare
C or porat ion; T homa s P u rdue
is quality analyst V, Boehringer
Ingelheim; Jeffrey Beebie is director
and GLP QA team lead, Pfizer, Inc.;
Kerri Robles is director, quality labo-
ratory practices, Bristol Myers Squibb;
and Karen Waetjen is director, GCP/
GLP Compliance, Amgen; all authors
are members of the IQ Consortium.
*To whom all correspondence should
be addressed.
Regulatory Sourcebook Quality Collaboration
