The FDA conducted an audit of Alkem Laboratories' facility in Daman, India from March 19-27, 2018. The audit uncovered 5 main observations, including out of specification drug batches being distributed, destroyed quality logs, backlogged stability testing samples, lack of integration parameters in chromatography, and improperly stored stability samples without temperature control or monitoring. The FDA recommended Alkem improve its quality control unit, documentation practices, stability study processes, sanitary conditions, and employee training to address the issues found during the audit. News reports indicated Alkem's stock prices dropped in response to the audit findings.

1. A CASE STUDY ON AUDIT
ALKEM LABORATORIES
(Daman and Diu, INDIA)
DATE OF INSPECTION- 19/3/18 – 27/3/18
FEI NUMBER- 3006370524
FDA Investigators- June P Page, Kellia Hicks
Office of International Programs employee-
Dipesh Shah

2. CONTENTS
• Objective of Auditing
• Observations by FDA
• Recommendation for minimizing the problems
• News about ALKEM audit
• Conclusion
• Reference

3. Objectives of Auditing
1. To determine the conformity or non-conformity of
the quality system in meeting the specified
requirements.
2. To determine the effectiveness of the implemented
quality in meeting the specified Quality objectives.
3. To provide the Audit team with an opportunity to
improve the Quality system.
4. To meet the regulatory requirement
5. To permit listing of the audited organizations Quality
systems in a register

4. OBSERVATION 1-
A) The quality unit confirmed an out of specification for
assay testing of usp tablets and was signed by head of
QC and QA on 08 nov 2017. tablets were distributed
to us market 4 months prior to product testing release
(24 july). And the certificate of analysis for the batch
was approved on 13 nov.
B) The firms QC analyst reviewer and QC assistant
manager stated that logbook for invalid analytical
results for system suitability for january was
destroyed. No corrective actions were taken to
address this failures.
C) The logbooks from warehouse, housekeeping, block
QA, QC, manufacturing are destroyed that are not
outdated.there are no written procedures addressing
the deletion of files.

5. OBSERVATION 2-
A) Pending samples for analysis of stability
batches, backlogged in process samples.
As of 19 mar 2018, the batch was found to be
pending 2 month stability testing still the
tablet batch were dispatched to US market.
B) The manufacturing for a tablet batch was
done on april 2017, The stability testing T0
were started on 19 jun, 3 months after T0
and 7 months after manufacturing the long
term stability testing was started. Results
were not reviewed and approved unti 21 mar
2018.

6. OBSEVATION 3-
Laboratory controls do not include the
establishment of scientifically sound and
appropriate specification, sampling plans and
test procedures designed to assure that drug
products conforms to appropriate standards
of identity, strength, quality and purity.
A) Integration parameter are not established to
ensure peaks are detected. Unknown peaks in
chromatographs due to inhibited integration
were not investigated.

7. OBSERVATION 4-
A) The firm fails to follow the procedure for
handling of Out of Specification (OOS) and Out
of Trends (OOT) results within the specified
timeframe in 2017.
111 OOS’s and 23 OOT’s were not completed
within specified timeframe.
B) The samples in sample storage area of central
laboratory lack the required information on
sample analysis sheet which are product
name, batch no. , manufacturing date,
expiration date, sampled by, date of sampling.

8. OBSERVATION 5-
On 23 mar 2018 FDA observed, 45 boxes of
pending and analyzed stability samples ,
which were store in “RH Room” without
temperature control or monitoring. There
was no log book or tracking of the samples
and their location.
The written stability testing program was not
followed.

9. Recommendation for minimizing the
problems
• A good quality control unit must be
integrated.
• Need for Proper documentation
• Stability studies must be improved
• Sanitary and sterile, clean conditions should
be maintained
• Training for employees.

10. News about ALKEM Audit
• Alkem gave no details of the findings but simply said that it would put
together a detailed response “with adequate corrective and preventive
measures to address the US FDA Observations” and send it to the FDA
within the agency’s stipulated timeframe.
• ALKEM labs dips 11% stocks as USFDA issues 13 observations for daman
facility.
• U.S. FDA Conducts Surprise Audit At Alkem Lab’s Daman Plant.
• USFDA has revealed the presence of “flying insects… including mosquitoes
and gnats” at the manufacturing unit. The drug regulator has also
observed that the plant — owned by one of India’s largest pharma
company — has “no quality control unit” at its facility.