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PQA811 Deviation report_Assignment2_E.Beilin

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Eugene Beilin
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54 views

PQA811 Deviation report_Assignment2_E.Beilin

College Assignment

Uploaded by

Eugene Beilin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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EXCEL

EXCEL PHARMACEUTICALS INC. PHARMACEUTICALS

Deviation Report Form 1-GEN-100-00


Revision Number: 0

1. Deviation report ID:


Deviation Report Reported by/Department: Date reported:
Number:
DR 1-2014 Eugene Beilin, Quality October 02, 2014
Assurance

2. Deviation type (check all that apply):


    
Customer Material/ Process/ Audit EHS
complaint Product Procedural
Loss Deviation
    
Incident Failure to meet Discrepancies Unusual Other
specifications occurrenc
es

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.

Nature of the complaint: the temperature monitoring device


TempTale®4USB Monitor (Sensithech Inc.) was missing in one out of 12
boxes of PQA811 Injection, lot No. 20140925 shipped to the customer.

Details: The quantity of PQA811 Injection, lot No. 20140925 shipped to


OpperXmart: 12 carton boxes strapped to a wooden palette, 1000x5 ml vials
per box, total: 12,000 vials. The shipment was performed by a third party
shipment company Pharma-Oppa! Inc.
Review date: 2015-05-14 Page 1 of 5
EXCEL
EXCEL PHARMACEUTICALS INC. PHARMACEUTICALS

Deviation Report Form 1-GEN-100-00


Revision Number: 0

Possible cause:
Shipping SOP TR-2013-123 was not followed

Immediate corrective actions taken:


1. The QA and Shipment Department Managements and personnel were
notified immediately about the incident.
2. Investigation No. INV-123 has been initiated.
3. Based on the customer complaint C-ABC-2014-1 , a Recall procedure
has been initiated
Name: Signature: Date:
Eugene Beilin, QA October 2, 2014
Associate
5. Area Management Response
Deviation Analysis and Investigation:
The PQA811 Injection is a temperature sensitive drug product and must be
stored and shipped at 2-8°C in the temperature controlled environment,
according to SOPs STOR-123 and TR-2013-123.
As per SOP TR-2013-123 the Temp Tale device must be manually inserted
in each carton box containing the PQA811 Injection; however, the
temperature monitoring device was missing in one out of 12 shipped
boxes during shipment to OpperXmart on October 2, 2014.

Investigation No. INV-123 findings:


1. Track licence plate No. AGPN888 (Pharma-Oppa! Inc.) was loaded at
the West dock and had left for the OpperXmart, located on 125
Emerald Gren St., Worse York, XXX XXX on October 02, 2014 at 6:30
am.
2. The track was unloaded on October 02, 2014 at 9:30 am.
3. Mr. Pack, Supervisor of the shipping crew, was questioned; he
indicated that Mr. Smith, Senior packager performed the above
package preparation for shipment.
4. Further questioning of Mr. Smith revealed that he was lacking one
Temp Tale device and decided not to request another one from QA
office ”because he didn’t want to hold the track waitin’ n’ them boxes
were n’ one palette anyway”.

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

Deviation Report Form 1-GEN-100-00


Revision Number: 0

2. Mr. Smith was fired immediately upon conclusion of the investigation.


3. All documentation re: other temperature sensitive goods prepared and
shipped by Mr. Smith have been re-inspected, including reconciliation
of the used TempTales devices and their records verification.

Title: Name: Signature: Date:


Manager, Isa Abu Aladdin October 2,
Distribution 2014

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

Deviation Report Form 1-GEN-100-00


Revision Number: 0

12. GMP Training for QA and Distribution Departments will be


re-scheduled – training frequency will be increased
13. All-Staff emergency meeting will be called and the incident
will be discussed
14. Spot checks/audits of the QA aspects of Manufacturing,
Packaging and Distribution areas will be scheduled and performed
regularly as per defined time intervals.
Title: Name: Signature: Date:
QA Manager Hassan Ibrahim October 6, 2014

7. Deviation Report Approvals


Name/Title Title Signature Date
Ali Baba Director, October 6,
Quality and 2014
Compliance

Paul Director, October 6,


Frankenstein Operations 2014

Tokugawa Director, October 6,


Hidetada Marketing 2014

8. Impact Analysis Template Change History

ISSUE DATE DESCRIPTION


2013-05-14 New Deviation Report Form

9. Deviation Report Form Authorship

QA Associate, Quality and Director, Operations


Compliance
Author Approval Reviewer Approval

10. Deviation Report Form Approvals

Review date: 2015-05-14 Page 4 of 5


EXCEL
EXCEL PHARMACEUTICALS INC. PHARMACEUTICALS

Deviation Report Form 1-GEN-100-00


Revision Number: 0

Director, Quality and Compliance Manager, Change Control


Quality Approval Operations Approval

Review date: 2015-05-14 Page 5 of 5

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