Quality Progress - March 2017 - 16


Field Notes
engaged in the falsification
deletion or manipulation was found.
of
documents
is
troubling
Your response and comments focus
Data integrity is a
and
raises
questions
about
primarily on the issue of intent, and
basic element of
validity
of
documents
gendo not adequately address the serigood documentation
erated
by
your
fi
rm."
ousness of the CGMP violations found
practices, one of the
Senior
management,
during the inspection."
Commitment
most fundamental
especially
those
with
from all
pillars of any quality
REFERENCES
quality management
Data integrity enables
management system,
1. "India: EU Bans 700 Generic Drugs Alleging
responsibilities, should
good decision-making
Manipulation of Trials by GVK Biosciences,
including current
Company Denies Claim," Business and Human
ensure that data integrity
by manufacturers and
good manufacturing
Rights Resource Center, http://tinyurl.com/
risk
is
assessed,
mitigated
regulatory authorities. It is
practices.
qp-eu-hr-center.
and communicated in
a fundamental mandatory
2. U.S. Food and Drug Administration (FDA),
Draft Guidance for Industry "Data Integrity
accordance with the
requirement of the medical
and Compliance With CGMP-Guidance for
principles of quality risk management.
products quality system, applying equally
Industry," draft guidance, April 2016, http://
The effort and resources assigned to data
to manual (paper) and electronic systems.
tinyurl.com/qp-fda-draft-guide.
3. Sarah Barkow, "Current Expectations and
integrity measures should be commenTo ensure data integrity, senior manageGuidance, Including Data Integrity and
surate with the risk to product quality,
ment must engage in the promotion of a
Compliance With CGMP," FDA presentation at
and balanced with other QA resource
quality culture along with the implementhe International Society for Pharmaceutical
Engineering's Data Integrity Workshop,
demands. Where long-term measures are
tation of appropriate organizational and
Bethesda, MD, June 5, 2016, http://tinyurl.com/
identified to achieve the desired state of
technical controls. It requires participation
qp-barkow-present.
control, interim measures should be imple- 4. FDA, "Inspectional Observations-Form FDA
and commitment by staff at all levels
483" Ranbaxy Laboratories Ltd. example,
mented to mitigate risk and should be
within the organization, by the organizaJanuary 2014, http://tinyurl.com/qp-fda-form.
monitored for effectiveness.
tion's suppliers and by its distributors.
5. Alexander Gaff ney, "India's Data Integrity
Data integrity is a basic element of
Problems," Regulatory Aff airs Professional
Society, Feb. 3, 2015, http://tinyurl.com/
good documentation practices, one of the
Data integrity and
qp-raps-data-integrity.
most fundamental pillars of any quality
human error
6. Pharmaceutical Inspection Convention, "Draft
management system, including CGMP.
PIC/S Guidance: Good Practices for Data
Finally, remember that regulators do not
Management and Integrity in Regulated GMP/
Upper management, and especially qualdistinguish between human error or slopGDP Environments," Aug. 10, 2016, www.
ity leaders at every regulated organization piness, and data falsifications and fraud
picscheme.org/layout/document.php?id=714.
must ensure that everyone is accountable
when assessing the impact of data integrity 7. FDA, "Marck Biosciences Ltd. Warning
Letter," July 8, 2014, http://tinyurl.com/
for their actions, including having proper
failures, as demonstrated in the following
qp-fda-warn-letter.
documentation of activities performed.
excerpt from a 2015 FDA warning letter:8
8. FDA, "Apotex Research Private Ltd. Warning
Unfortunately, most regulated organiza"In correspondence with the
Letter," Jan. 30, 2015, http://tinyurl.com/
qp-fda-warn-letter2.
tions only react to data integrity issues
agency, you indicate that no maliafter regulators discover them.
cious data integrity patterns and
FOR MORE INFORMATION
An outrageous example of this can be
practices were found. Also, you
Parenteral Drug Association (PDA), PDA Letter
April 2015.
found in a warning letter7 issued in July
state that no intentional activity to
International Society for Pharmaceutical
2014 in which the FDA required an orgadisguise, misrepresent or replace
Engineering, "Special Report: Data Integrity,"
nization to "identify the specific managers
failing data with passing data was
Pharmaceutical Engineering, March/April 2016,
Vol. 36, No. 2, pp. 40-66.
in place who participated in, facilitated,
identified and no evidence of file
encouraged or failed to stop subordinates
from falsifying data in CGMP records, and
determine the extent of top and middle
José Rodríguez Pérez is president of Business Excellence
Consulting Inc. in Guaynabo, Puerto Rico. He has a doctorate in
management's involvement in or awarebiology from the University of Granada in Spain. A senior ASQ
ness of data manipulation." In the same
member, he has many ASQ certifications: auditor, biomedical
inspection, the FDA also discovered that
auditor, hazard analysis and critical control points auditor, engineer,
manager of quality/organizational excellence, pharmaceutical good
"your firm falsified documents designed
manufacturing practices professional and Six Sigma Black Belt. His
to demonstrate the effectiveness of CGMP
most recent book is Handbook of Investigation and Effective CAPA
training ... That a senior manager was
Systems (ASQ Quality Press, 2016).
chromatography [HPLC]
testing sequence versus
recording only at the
end of the day).

16 QP

March 2017 ❘ qualityprogress.com


http://www.tinyurl.com/ http://www.tinyurl.com/qp-fda-draft-guide http://www.tinyurl.com/qp-barkow-present http://www.tinyurl.com/qp-fda-form http://www.tinyurl.com/qp-raps-data-integrity http://www.picscheme.org/layout/document.php?id=714 http://www.tinyurl.com/qp-fda-warn-letter http://www.tinyurl.com/qp-fda-warn-letter2 http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - March 2017

Seen and Heard
Expert Answers
Progress Report
Mr. Pareto Head
Field Notes
Innovation Imperative
Hard Wired
Propel Forward
Life After Disruption
Work Smarter, Not Harder
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Back to Basics
Quality Progress - March 2017 - cover1
Quality Progress - March 2017 - cover2
Quality Progress - March 2017 - 1
Quality Progress - March 2017 - 2
Quality Progress - March 2017 - 3
Quality Progress - March 2017 - 4
Quality Progress - March 2017 - 5
Quality Progress - March 2017 - Seen and Heard
Quality Progress - March 2017 - 7
Quality Progress - March 2017 - Expert Answers
Quality Progress - March 2017 - 9
Quality Progress - March 2017 - Progress Report
Quality Progress - March 2017 - 11
Quality Progress - March 2017 - 12
Quality Progress - March 2017 - Mr. Pareto Head
Quality Progress - March 2017 - Field Notes
Quality Progress - March 2017 - 15
Quality Progress - March 2017 - 16
Quality Progress - March 2017 - 17
Quality Progress - March 2017 - Innovation Imperative
Quality Progress - March 2017 - 19
Quality Progress - March 2017 - 20
Quality Progress - March 2017 - 21
Quality Progress - March 2017 - Hard Wired
Quality Progress - March 2017 - 23
Quality Progress - March 2017 - 24
Quality Progress - March 2017 - 25
Quality Progress - March 2017 - 26
Quality Progress - March 2017 - 27
Quality Progress - March 2017 - Propel Forward
Quality Progress - March 2017 - 29
Quality Progress - March 2017 - 30
Quality Progress - March 2017 - 31
Quality Progress - March 2017 - 32
Quality Progress - March 2017 - 33
Quality Progress - March 2017 - Life After Disruption
Quality Progress - March 2017 - 35
Quality Progress - March 2017 - 36
Quality Progress - March 2017 - 37
Quality Progress - March 2017 - 38
Quality Progress - March 2017 - 39
Quality Progress - March 2017 - Work Smarter, Not Harder
Quality Progress - March 2017 - 41
Quality Progress - March 2017 - 42
Quality Progress - March 2017 - 43
Quality Progress - March 2017 - Statistics Spotlight
Quality Progress - March 2017 - 45
Quality Progress - March 2017 - 46
Quality Progress - March 2017 - 47
Quality Progress - March 2017 - Standard Issues
Quality Progress - March 2017 - 49
Quality Progress - March 2017 - Marketplace
Quality Progress - March 2017 - 51
Quality Progress - March 2017 - Footnotes
Quality Progress - March 2017 - 53
Quality Progress - March 2017 - 54
Quality Progress - March 2017 - 55
Quality Progress - March 2017 - Back to Basics
Quality Progress - March 2017 - cover3
Quality Progress - March 2017 - cover4
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