CAPA FORM

CAPA Ref. No.

Start Date:

CAPA
SOURCE

Non-Conformity
from Audits

CATEGORY

Document
Control

From
Complaints /
Notices/ Third
Parties

System Failure

Suggestion for
Improvement

Others
---------------------------

Training/Operator
Fault

Wrong Procedure
/Instructions

Non-Conformity / Complaint / Observation

Presence of hair in filled and reconstituted vials of Cefotrim Injection 1gm Batch No. 281.

Current Status
Not Applicable

CAPA Leader & Team

CAPA Leader:

Zahid Nazir

Team Members:

1.

Abdul Karim
4.

2.

M. Nasir

3.

5.

6.
Root Cause Analysis
Tool Used:
Fishbone Analysis, Cause and Effect Diagram, Gemba, Brain Storming,
Conclusion:
Following are deficiencies in Ceph. Dry Powder Injectable area which can be the potential cause
of contamination in
Filled vials.
i). After Sterilization, depyrogenated vials are stored in SS Trays without Lid.
ii). Vials are fed to the turntable manually without Laminar Flow Protection.
iii). Rubber Stoppers are stored in a SS container in Class B area (open to environment) and fed
into the stopper hopper
with a SS bowl without Laminar Flow Protection.

Page 1 of 3
CAPA Form
Ref SOP No. QA/GEN/005/01

iv). Powder is fed into the Powder Hopper by opening the filling cabinet door.
v). Ways of Working of Staff is not as per standard aseptic practices.
vi). There is no in-process testing for Clarity.
vii). There is no visual inspection of filled vials under illuminated background.

CAPA Leader:
______________________
____________________________

QA Manager:

Corrective & Preventive Action (CAPA)

Corrective Action

Responsibilit
y

Target
Completion
Date

Actual
Completion
Date

Responsibilit
y

Target
Completion
Date

Actual
Completion
Date

Provision of Storage LFC in cooling area for

the storage of depyrogenated vials, seals,
rubber stoppers etc.
Use of SS trays with lid for depyrogenated
vials and modification in LFC for feeding of
vials.
Storage of Rubber Stoppers under LAF.
Training of staff working in Sterile area on
aseptic techniques.
Inclusion of Clarity Test as in-process check
after every 30 minutes of filling.
100% visual inspection of filled vials before
labeling operation.
Preventive Action
Training and refresher courses for
management and non-management staff
working in aseptic areas.

CAPA Approved By
QA Manager : ______________________________
___________________________

Head of Plant Operations:

Page 2 of 3
CAPA Form
Ref SOP No. QA/GEN/005/01

Post Implementation Review

CAPA Leader:
______________________
____________________________

QA Manager:

CAPA Closure

CAPA Leader:
______________________
____________________________

QA Manager:

Page 3 of 3
CAPA Form
Ref SOP No. QA/GEN/005/01