fda's top data integrity issues during the inspections

FDA’s Top Data Integrity Issues Found During Inspections

2 March 2016

FDA’s Top Data Integrity Issues Found During Inspections

Data Integrity:

"is the common issue that

inspections. When FDA finds anyinspections. When FDA finds any

during inspection, it is considered

of the products manufactured

facility cannot be good. FDA

the violation of 21 CFR part 11

""

is found during the FDA

any invalid or unreliable dataany invalid or unreliable data

considered by FDA that the quality

manufactured in such a manufacturing

issues warning letter when

11 is found during inspection.

Common data integrity issues observed by FDA during their inspections:

1. Data Manipulation: Alteration

original data to obtain theoriginal data to obtain the

manufactured product is very

quality control laboratories. The

whitener to hide the original

correction are against the GMP

data integrity issues observed by FDA during their inspections::

Alteration or manipulation of

the passing results for anythe passing results for any

very common issue found in

The analyst may use fluid or

original results. These methods of

GMP and GDP regulations.


2. Multiple Sample Runs:

analysis any sample is runanalysis any sample is run

passing results. Some analysts

these multiple runs. This issue

pharmaceutical companies.


: During the HPLC and GC

multiple times to get themultiple times to get the

analysts delete the data files of

issue is found in many Indian


3. Back Dated Documentation

done in stability analysis. Samplesdone in stability analysis. Samples

backdate by changing date in

of various regions such as

system or manpower. Back

serious issue by FDA.


Documentation: Generally back dating is

Samples are run on HPLC inSamples are run on HPLC in

in computer system because

unavailability of the HPLC

dating is considered as a


4. Unauthorized Data Access

electronic data generated byelectronic data generated by

analyst is unauthorized data

generating electronic data must

Electronic raw data of all analyzed

archived and available on demand


Access: Deletion or alteration of

different instruments by thedifferent instruments by the

data access. All instruments

must be audit trail enabled.

analyzed samples must be

demand.


5. Logbook Recording: When

any instrument and it is notany instrument and it is not

logbook or timing mismatch on

as balance and HPLC logbooks

is not done actually and fake report


When any activity is done on

recorded in the instrumentrecorded in the instrument

on different instruments such

logbooks. FDA considers that activity

report is prepared.


6. Data Copying: When any

done and the data or resultsdone and the data or results

instead of the actual analysis.

fairly by coping electronic data

rename it with new batch

calculating the results for new


any activity or analysis is not

results of previous batch are filledresults of previous batch are filled

. Some analysts does it very

data file of previous batch,

number and use this data

new batch.

Thank you for your attention!!Thank you for your attention!!Thank you for your attention!!Thank you for your attention!!

fda's top data integrity issues during the inspections

Health & Medicine