Event No.

BQAE 14/012
Section 1: Event information
1.1 Date event occurred 21/06/14
1.2 Date identified 22/06/14
1.3 Shift/ time General
1.4
Responsible Dept.
(Business Unit)
Quality assurance
1.5
Is it batch related?
(Check one)
yes, complete section 1.5a- 1.5d below No
1.5a Product Name (s) Piperacilin & Tazobactum for injection USP 3.375g
1.5b List No./Product Code/ Market 501/US Market
1.5c Batch/Lot Number (s) 501E013
1.5d Contract Manufactured Product? (check one)
Yes No If Yes, provide Customer Name
1.6
Name and No. of
affected equipment
Not Equipment Related
1.7
Physical location of Affected Area (i.e. Room
#, Line, etc)
Not specific to a location or area
1.8
Describe what happened. Include as much
detail as possible.
Inprocess specification worksheet is not available at the
time of sampling of bulk solution.
1.9
Describe in which step of the process the
event occurred (i.e. Compounding, Setup,
Filling, Beginning or End of Run, Entire
process, lab testing, etc)
Sampling of bulk solution by QC
1.10
If known, what type of problem is it? (i.e.
equipment malfunction, line clearance event,
audit failure, OOS, Calibration, etc.)
Failure of QA personnel to obtain the worksheets from
QA document cell inline with the production plan
Hospira Healthcare India Pvt. Ltd.
Initial contact form (ICF)
Note: Must be completed and initiated within 1 working day of the event identification.
Event Description:
Apotex
Format No.: QA023-F10-00 Page 1 of 4
Event No. BQAE 14/012
Hospira Healthcare India Pvt. Ltd.
Initial contact form (ICF)
1.11
If a requirement was NOT met, list the
document number and the requirement. (i.e.
Batch Record, specification, SOP,
Monograph, etc)
N/A Not related to a requirement
Document Number: QC 021
Requirement/Limit/Range: QA has to provide the
samples, worksheet and request to QC.
1.12
If documentation error (missing signatures or
dates, data not verified etc.) provide details.
Attach copy of documentation showing the
error.
N/A Not related to a requirement
Document Number:
______NA_________________________
Document name:
__________________NA___________
Type of error: ________________NA______________
1.13
List the involved employee(s)
ID number or Full Name.
Who identified event?: Karthikeyan (80106248)
Who was involved with the event?: Other QA personnel
(8008.)
1.14
What do you think caused the event? (i.e.
Preliminary/potential causes, your
observations, areas to further investigate, etc)
a) May be due to the tight schedule of Audit preparation
b) May be due to the overlook, since QA is not involved
in sampling activity.
1.15
What immediate corrections or corrective
actions were taken?
QC shall analyse the bulk sample without the worksheet
and the results can be transcribed after the availability of
worksheet on next working day.
Initiator sign/date: HOD sign/ date
Section 2: Initial Product Impact Assessment and Containment
Note: must be completed within 3 working days of the event identification
2.1
Enter how many items of the material (# of
trays, loads, vials, batches etc.) have been
directly affected and provide justification.
NIL
2.2
What were the containment actions or steps
taken to control the event? Explain how the
materials were identified and segregated.
NA
2.3
Explain why it is acceptable to continue with
processing of the room/ product/ equipment,
etc.
Format No.: QA023-F10-00 Page 2 of 4
Event No. BQAE 14/012
Hospira Healthcare India Pvt. Ltd.
Initial contact form (ICF)
2.4
Was additional testing/ sampling or other
action immediately taken to address this
event? i.e. Additional fill volume samples,
retests, resampling. Provide rationale for
answer.
Yes No (If Yes, what were the results?)
2.5
Is this event restricted only to the lot in
question? Provide rationale for answer.
Consider impact of event on other lots on
the same lines/equipment at, before and
after this event
N/A
Yes No (If No, list other lots that may be
affected)
2.6
If this event involves a raw material or
component, other lots, manufacturing lines/
areas impacted? Provide rationale for answer.
N/A Not Related to a Raw Material or Component
Yes No
2.7
If you answered yes in 2.6, document the
supplier information including supplier name,
supplier lot number, material name and
material grade.
N/A Not Related to an Incoming Item
HOD sign/ date
Section 3: Historical Search
Note: Work with a member of the QA to complete the section below
3.1
What were the results of the historical search?
Attach the historical search report.
No such events or incidents reported in past 24 months
3.2
Were any trends identified during the
historical search?
Yes No (If Yes, state the trend identified)
HOD sign/ date QA Sign/date:
Initiator sign/date:
QA sign date
Format No.: QA023-F10-00 Page 3 of 4
Event No. BQAE 14/012
Hospira Healthcare India Pvt. Ltd.
Initial contact form (ICF)
List of supporting documents attached( 1, 2,3,4,5..)
Section 4: Field Alert
Note: must be completed within 3 working days of the event identification.
4.1 Field Alert Action (check one)
Yes No (If No, provide justification)
QA Sign/date:
Section 5: Level Classification
Note: must be completed within 3 working days of the event identification.
5.1 Event Classification (check one)
Low Med High
If High, is a notification to management required?
Yes No (If No, provide justification)
5.2
Provide justification and reasoning for level
selected
QA Sign/date:
Section 6: QA Comments/ Disposition:
QA Sign/date:
Format No.: QA023-F10-00 Page 4 of 4