Data Integrity

Amit Kumar Mishra

26-03-2022 1
What is Data Integrity

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 Introduction
• What is data integrity
• Data integrity means:
– Accurate and reliable data
– Trustworthy data
– Original data
– Secured data

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Why Data Integrity Is important

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 Why is it important
• Provides assurance of quality
• Lack of integrity leads to loss of faith in
the organization
• Loss of faith leads to loss of business
• Lack of integrity results in punitive
actions by regulators

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What Drug Regulations Say

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 What FDA says
• 21 CFR Part 211.160 Laboratory Controls
• The requirements in this subpart shall be
followed and shall be documented at the
time of performance.
• Any deviation from the written
specifications, standards, sampling plans,
test procedures, or other laboratory control
mechanisms shall be recorded and justified.
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 What FDA says
• Sec. 211.68 Automatic, mechanical, and
electronic equipment
• Automatic, mechanical, or electronic
equipment or other types of equipment,
including computers, or related systems that
will perform a function satisfactorily, may be
used ……. written records of those calibration
checks and inspections shall be maintained.

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 What FDA says
• Sec. 211.68 Automatic, mechanical, and
electronic equipment
• Input to and output from the computer or
related system of formulas or other records or
data shall be checked for accuracy

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 What FDA says
• Sec. 211.68 Automatic, mechanical, and
electronic equipment
• A backup file of data entered into the
computer or related system shall be
maintained except where certain data, such as
calculations performed in connection with
laboratory analysis, are eliminated by
computerization or other automated processes

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 What FDA says
• Sec. 211.68 Automatic, mechanical, and
electronic equipment
• In such instances a written record of the
program shall be maintained along with
appropriate validation data

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 What EU GMP Says
• Records should be made or completed at the
time each action is taken and in such a way
that all significant activities concerning the
manufacture of medicinal products are
traceable

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 What EU GMP Says
• Any alteration made to the entry on a
document should be signed and dated; the
alteration should permit the reading of the
original information. Where appropriate, the
reason for the alteration should be recorded

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 What EU GMP Says
• Logbooks should be kept for major or critical
analytical testing, production equipment, and
areas where product has been processed.
They should be used to record in chronological
order, as appropriate, any use of the area,
equipment /method, calibrations,
maintenance, cleaning or repair operations,
including the dates and identity of people who
carried these operations out.

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 What other regulations say
• In some form or other, ALL drug regulations
emphasize the importance of data and data
integrity

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 Key data
• Release testing data
– Should meet the spec
– Should meet filing commitments
• Stability testing data
– Should be without significant deviations
• For all data, real-time recording is a must

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 Key data
• Comparison of raw data
– Hard copies of format and reports
– Weighing slips
– Chromatograms HPLC, GC, TLC etc.
– Spectra IR, UV etc.
– Calculations
– Note books
– Electronic copies

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 Key data
• Type of data
– Purely manual paper data
– Exclusively electronic data
– Hybrid data – combination of paper and
electronic data
• Back up system for all type of data should be
robust and should be able to be demonstrated
for its integrity

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 Common deficiencies
• Non availability of data itself
• Inaccurate and incorrect data
• Unauthorized corrections
• Authorized corrections but not justified
• Absence of date and details of operators
• Absence of original electronic data

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 Common reasons
 Human errors - unintentional mistakes
 Lack of awareness of regulatory requirements
 Falsification of data to cover up mistakes
 Lack of staff to do job systematically
 Undue pressure from management
 Middle managers eagerness to show
everything ‘under control’
 Attitudinal problems

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 Area of main concerns
 BMR and BPR
 Analytical reports
 Stability testing reports
 Calibration records
 Training records
 Cleaning and sanitation records

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 Way forward
 If you have understood the reasons for data
integrity issues, you are the best judge to
suggest way forward
 Let us discuss

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