EEffi QAI WEEKLY ROUTINE INSPECTION REPORT Form No.

OP-10005-F02

Audil Reporl No.: QAr-20r9-003

AM.EUROPHARMA CORPORATION
Audited Site: Audit Dote(s): Morch 28,2019
Boronooy Soimsim, Colombo City, Lqqunq
Audiled Areo(s): Suooort Fociliiies * Premises ond Eouioment Poqe: 1of 3

Item Correclive Aclion / Prevenlive

Colegory Audil Flndings Root Couse Torget Dote Remorks
No. Aclion

I MINOR Compressor- Ceccolo ond GA Numberwos removed

Atlos Copco Compressed Air
mochine hos no Equipmenl
Number tog.
2 MINOR Used otiochmenl monitoring
form #OP-l 2032/FOl indicoled os
poper test ond nol monitoring
form os perSOP.
3 MINOR Monitoring Form ottochmenl
revision number wqs noi
updoted in the SOP.
from lhe body during
cleoning due to old slicker. Provide number for the equipmenl. Morch 30,2019 Done
This is the revised form
numberwhen OP-12032
wos generoted. the some
poper test form wos
included in the SOP-12014 Non Required NIA Done
os OP-1201414/F0l
previously ond wos not
chonge in lhe lost
submilted OP revision.
Clericol enor during Corrected enor ond prompt review &
documentolion typing. revision of OP-12014 content lo motch
form no. OP-12032? F0l in the April 30, 2019 Done
ottochment / reports.

Recommendolion

( ) To olwoys obgerve Good Monufoclurlng Proclice/ Good Sloroge Proclice

( ) For follow-up inspection

Direclives

For Coneclive Aclion / Prevenlive Ac-tion ( CAPA)

 INTERNAL QUALITY AUDIT REPORT Form No. OP-10005-F02

Audil Reporl No.: QAr-20r9-003

AM-EU ROPHARMA CORPORATION
Audited Siie: Audil Dote(s): Morch 28,2019
Boronqoy Soimsim, Colombo City, Loquno
Audiied Areo(s): Support Focilrties - Premises ond Equipment Poqe: 2of3

llem Correclive Aclion / Prevenlive

Colegory Audit Findings Rool Couse Iorgel Dole Remqrks
No. Aclion

Address lhe deficiencies ond submit the CAPA Plon including submission of objective evidence of complionce within lhe specified
limeline reckoned on lhe following doy of receipl of summory of observotions/findings:

( ) Twenty five (25) colendor doys for crilicoldeficiencies

( ) Ihirty five (35) colendors doys for mojor ond olher deficiencies

lnspecled By:

Auditor Audilor
leonordo Dionisio Celerino Somonte

The Complionce-reloted Risk bosed on lhe inspection

Ihe complionce risk indicoled by lhe most
recent deficiency profile of lhe oreo is E Low - No mojor or criticoldeficiencies

E Medium - I io 5 mojor deficiencies : No. Of mojors

- l0 ond obove minors or olhers : No. Of Minors

E High - I or more crilicoldeficiencies or more thon 5 mojors

Complionce Mode by the Areo

 -qww INTERNAL QUALITY AUDIT REPORT I,brm No. OP-10005-1.'02

Audil Repori No.: QAI-2019-003

AM-EUROPHARMA CORPORATION
Audited Site: Audit Dote(s): Morch 28,2019
Boronooy Soimsim, Colombo City, Loquno
Audited Areo(s): Support Focilities - Premises ond Equipment Poqe: 3of3

llem Correclive Aclion / Prevenlive

Colegory Audit Findings Rool Couse Torget Dote Remorks
No. Action

( Submitled CAPA
( Accepled
( Nol occepted

Recommendolion:

Prepared by:

Ba utista
ne leader

Noted by:

(Y1'n
Virs(fGatdula
EMD Manager