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Data Integrity

This document summarizes common data integrity issues found during FDA inspections of pharmaceutical companies. The top citations include: failing to retain complete raw data from laboratory tests; deleting, manipulating, or failing to collect electronic data; backdating or pre-dating records; and reporting passing results after multiple analytical methods or repeated testing. Other frequent issues involve incomplete batch records, pre-determining test outcomes, and falsifying or destroying documentation. The document stresses the importance of ensuring all data is attributable, contemporaneous, original, accurate and trustworthy to maintain data integrity as required by regulations.

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davincicode888
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© © All Rights Reserved
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Download as PPTX, PDF, TXT or read online on Scribd
291 views

Data Integrity

This document summarizes common data integrity issues found during FDA inspections of pharmaceutical companies. The top citations include: failing to retain complete raw data from laboratory tests; deleting, manipulating, or failing to collect electronic data; backdating or pre-dating records; and reporting passing results after multiple analytical methods or repeated testing. Other frequent issues involve incomplete batch records, pre-determining test outcomes, and falsifying or destroying documentation. The document stresses the importance of ensuring all data is attributable, contemporaneous, original, accurate and trustworthy to maintain data integrity as required by regulations.

Uploaded by

davincicode888
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Data Integrity Test

ALCOA+

ALCOA+
A

Attributable

Authentication, Unique ID, Access permission

Legible

Human readable, Usable format

Contempora
neous

Recorded at the time of the event, audit trail

Original

Audit trail, record linking

Accurate

Reliable, calibrated

7th Most Common Citation

Your firm failed to document production and


process control functions at the time of
performance
Operator recorded the amount of material
dispensed before it was dispensed
Employees admitted they do not record
activities at the time of performance
QA employee signed as reviewing and
releasing a batch when he did neither

6th Most Common Citation


Your firm blended out-of-specification API
batches with passing batches to meet
specification.
Failing results were often kept in
separate folders and the failing data
was not considered when making
release decisions

5th Most Common Citation


Your firm did not document laboratory
activities at the time of performance.
Pre-dating or backdating laboratory
records
Occurred for assay, loss on drying,
sample weighing, and stability testing

4th Most Common Citation


Your firm failed to maintain complete
information relating to the production and control
of each batch
Records for 23 batches did not contain batch
numbers, manufacturing dates, expiration or
retest dates
Approximately 75 ripped batch production
records (BPRs) were found in the garbage
(some with failing results)

4th Most Common Citation


Ten bags of torn or partially destroyed
original records including CAPAs,
preventative maintenance forms, and
calibration records were found
Raw data was written on scratch paper and
sometimes differed from the data in the BPR
Correction fluid was used on production
records

3rd Most Common Citation


Your firm failed to thoroughly investigate any
unexplained discrepancy or failure of a batch or any of
its components to meet any of it specifications, whether
or not the batch has already been distributed
4 batches of failing API were used in fifteen finished
dosage batches
Failing assays were repeated until passing results
were obtained (occurred at numerous firms)
Environmental monitoring results were recorded as
zero but actually had growth

3rd Most Common Citation


Unofficial visual exam conducted for
sterile injectables to remove vials with
visible contamination so that the batch
would pass the official visual exam
(occurred at 2 firms)
Used three different analytical methods
until obtaining passing results

2nd Most Common Citation


Your firm failed to exercise appropriate controls over computer
or related systems to assure that only authorized personnel
institute changes in the master production and control records,
or other records
Audit trails were disabled
A shared username and password was used by many
analysts
Users were able to manipulate, delete, or overwrite
electronic raw data
Firms laboratory practice is to print chromatograms and
delete electronic raw data files

Most Common Citation


Your firm failed to ensure that laboratory records included
complete data derived from all tests necessary to assure
compliance with established specifications and standards
trial sample injection data was not kept as part of the
data for a batch
Sample weights, sample preparation and sample
dilutions were not retained
Deleted data detected in audit trails
Overwriting data
Ripped up data found in the garbage

Most Common Citation


Microbiological data missing
Not reporting microbiological counts
Hundreds of environmental monitoring samples
were not collected
Some microbiological sample plates/tubes were
missing from the incubator
No microbiological testing was conducted;
however, microbiological test results were
reported on the certificate of analysis (COA)

Most Common Citation


Certificates of analysis missing data:
Data on the COA sent with the batches was different
than the COA the firm retained on file
COA retest date was changed to an expiration date
and listed as eleven months later

No raw data in support of results reported on COA


Samples with no identification were discarded
during the inspection

Most Common Citation


Firm deleted all electronic raw data supporting
HPLC release testing
Standards were injected and used as sample
results
Duplicate logbooks were kept
Complete raw data to support test method
validation was not retained
Integration parameters for HPLC analysis were not
retained

ALCOA

ALCOA

ALCOA

ALCOA

ALCOA

ALCOA

ALCOA

ALCOA

ALCOA

ALCOA

Data Review

Data Review

Data Review

Data Review

Data Review

Data Review

Data Review

How Can You Be Part of the Solution


Look for gaps in how you control your
records
Ensure employees have appropriate user
privileges
Audit your data in a risk-based manner
Verify the authenticity of your
contractors data

Data Integrity in QC
Trial
Injections
Reprocessi
ng

DATA
INTEGRI
TY
Orphan
Data

PaperBased
Review

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