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CAPA FORM

CAPA Ref. No. Start Date:

CAPA

SOURCE

Non-Conformity

from Audits

From

Complaints /Notices/ Third

Parties

Suestion for

!mpro"ement

#thers

----------------------------

CATEGORY Document

Control

System Failure Trainin/#perator

Fault

$ron Procedure

/!nstructions

Non-Conformity / Complaint / ObserationPresence of hair in %lled and reconstituted "ials of Cefotrim !n&ection 'm (atch No. )*'.

C!rrent Stat!s

Not Applica+le

CAPA "ea#er $ Team

CAPA ,eader: ahid Nair

Team em+ers: '. A+dul 0arim ). . Nasir 1.

2. 3.

4.Root Ca!se Analysis

Tool Use#%

Fish+one Analysis5 Cause and 67ect Diaram5 8em+a5 (rain Stormin5

Con&l!sion%

Follo9in are de%ciencies in Ceph. Dry Po9der !n&ecta+le area 9hich can +e the potential cause

of contamination in

Filled "ials.

i. After Steriliation5 depyroenated "ials are stored in SS Trays 9ithout ,id.

ii. ;ials are fed to the turnta+le manually 9ithout ,aminar Flo9 Protection.

iii. Ru++er Stoppers are stored in a SS container in Class ( area

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i". Po9der is fed into the Po9der ?opper +y openin the %llin ca+inet door.

". $ays of $or@in of Sta7 is not as per standard aseptic practices.

"i. There is no in-process testin for Clarity.

"ii. There is no "isual inspection of %lled "ials under illuminated +ac@round.

CAPA ,eader: =A anaer:

Corre&tie $ Preentie A&tion )CAPA*

Corre&tie A&tion

Responsibilit

y

Tar+et

Completion,ate

A&t!al

Completion,ate

Pro"ision of Storae ,FC in coolin area for

the storae of depyroenated "ials5 seals5

ru++er stoppers etc.Bse of SS trays 9ith lid for depyroenated

"ials and modi%cation in ,FC for feedin of

"ials.Storae of Ru++er Stoppers under ,AF.

Trainin of sta7 9or@in in Sterile area on

aseptic techniues.!nclusion of Clarity Test as in-process chec@

after e"ery 1> minutes of %llin.'>> "isual inspection of %lled "ials +efore

la+elin operation.

Preentie A&tionResponsibilit

y

Tar+et

Completion

,ate

A&t!al

Completion

,ateTrainin and refresher courses for

manaement and non-manaement sta7

9or@in in aseptic areas.

CAPA Appro"ed (y

=A anaer : ?ead of Plant #perations:

Pae of (CAPA FormRef S#P No. =A/86N/>>3/>'

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Post .mplementation Reie

CAPA ,eader: =A anaer:

CAPA Clos!re

CAPA ,eader: =A anaer:

Pae (of (CAPA FormRef S#P No. =A/86N/>>3/>'