PQA811 Deviation report_Assignment2_E.Beilin
PQA811 Deviation report_Assignment2_E.Beilin
3. Deviation title
Deviation of shipping procedure SOP No.TR-2013-123 dated October 02,
2014
4. Deviation Details
Discovered by: Title/Department : Date discovered:
QA Associate/Quality
Eugene Beilin October 2, 2014
Assurance
Material/Product
Procedure No.: Audit report No.:
name and Lot No.:
PQA811 Injection, lot
TR-2013-123 N/A
No. 20140925
Customer complaint
Specification No. Area/Team affected:
Ref No.
C-ABC-2014-1 ABC-123 QA and Distribution
Description:
On October 2, 2014 at 11:00 am the QA department received a complaint
from the customer OpperXmart, located on 125 Emerald Gren St., Worth
York XXX XXX in regards to PQA811 Injection, lot No. 20140925.
Possible cause:
Shipping SOP TR-2013-123 was not followed
Corrective Actions:
1. Recall of the package shipped without temperature monitoring device
has been initiated (along with QA Department)
Review date: 2015-05-14 Page 2 of 5
EXCEL
EXCEL PHARMACEUTICALS INC. PHARMACEUTICALS
6. QA Management Response
Further Investigation and Deviation Analysis:
1. Reviewing of all Training records of the shipping crew did not
disclose any deficiency – all records were in order
2. The absence of TempTale in the box- barcode No. aIII II II234 was
discovered by OpperXmart employee on October 02, 2014 at 10:30
am
3. The readings on the remaining TempTales of the shipment did not
register any temperature excursions off of the validated
temperature range; also, the time spent during shipping was within
the validated interval, as per Validation report of the
Transportation study AK-47.
4. It was confirmed that all the shipping boxes, including the one
under investigation, were insulated with Styrofoam inserts.
5. The root cause of the deviation: personal negligence and
complacency of the Senior Packager Mr. Smith.
Corrective actions:
6. The vials of PQA811 Injection, lot No. 20140925 shipped in the box
barcode No. aIII II II234 has been returned back to cold storage
facility at Excel Pharmaceuticals warehouse in Worth York (as per
Recall SOP REC-123).
7. Five randomly selected vials from the returned box have been sent
to QC lab for testing in order to confirm the product integrity -
safety and efficacy; destruction or recycling of the returned
product will be considered upon receipt of the testing results.
8. The 1000 recalled vials of PQA811 Injection have been replaced
with identical product and quantity as per Recall SOP REC-123.
Preventive actions:
9. Shipping SOP TR-2013-123 will be reviewed carefully and
modified, if necessary, through the Change Control SOP No. CC123
10. Self-Inspection program will be revisited; comprehensive
audit of the Distribution department will be performed by an the
external QA contractor
11. The audit report will be analysed by QA Management and the
recommendations to be implemented
Review date: 2015-05-14 Page 3 of 5
EXCEL
EXCEL PHARMACEUTICALS INC. PHARMACEUTICALS