Quality Progress - March 2017 - 15


Zooming in on industry-specific issues

by senior management (including that of quality leaders) to a
culture of quality and compliance.

Regulatory impact

Recently, a string of FDA-issued warning letters for data integrity
violations have been published on the agency's website. Specifically, from January 2015 to May 15, 2016, 21 out of 28 warning
letters given to drug manufacturers involved data integrity
issues.3
Some data integrity breaches during FDA inspections are
shocking. They range from backdating records in the presence
of two FDA inspectors,4 to documenting microbial results on a
certificate of analysis when the testing was never performed.5
Between 2015 and 2016, major regulatory bodies, such as
the European Medicines Agency (EMA), the FDA, the WHO,
and the Pharmaceutical Inspection Co-operation Scheme
(PIC/S), published guidance documents on the topic of data
integrity and data management.
In August 2016, the EMA and the PIC/S6 announced the
publication of a new GMP data-integrity guidance document.
Data from testing, manufacturing, packaging, distribution
and monitoring of drugs are used by regulators to review
the quality, safety and efficacy of drugs, so ensuring the
integrity and completeness of such data is important. This
document addresses the assessment of risk to data integrity,
risk-management strategies, design and control of electronic
and paper-based documentation systems, and ensuring data
integrity of outside contractors. It appears that regulators
are taking a closer look at data integrity industry wide.

The FDA released its own data integrity draft guidance
document in April 2016, which relies on numerous prior guidances. It reaffirms the critical role of quality functions and
quality professionals to ensure integrity of data:
+ For recording data, manufacturing or testing steps, numbered
and controlled forms must be issued and reconciled by quality assurance (QA).
+ Any findings of data integrity violations and "removing at all
levels individuals responsible for [data integrity] problems from
current GMP (CGMP) positions" must be disclosed to the FDA.
+ Before batch release, QA must review the audit trail and electronic testing.
+ Control strategies must be in place to ensure all original lab
records (paper and electronic) are reviewed (by a person), and
all test results are appropriately reported.
+ Immediate and irreversible recording of electronic testing data
(including after completing each high-performance liquid

TA B L E   2

Data integrity red flags
Backdating information.
Altering original data and records.
Creating acceptable test results without performing tests.
Documenting activities before execution.
Attaching sticky notes to quality control data packages.

qualityprogress.com ❘ March 2017

QP 15


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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