INTERNAL QUALITY AUDIT REPORT l,'orm No.

OP-10005-F02
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Audil Reporl No.: QAt-2019-003
AM_EUROPHARMA CORPORATION
Audited Site: Audil Dole(s): Morch 26,2019
Boronqov Soimsim, Colombo Citv. Loquno
Audited Areo(s): Liquid Areo - Premises ond Equipments Poqe: lof 3

llem Correclive Aclion / Prevenlive

Colegory Audit Findings Root Couse Torgel Dole Remorks
No. Action

I Compounding ll
Minor No reol time recording of
compounding of RM linc Z 120m1
lot# 19FS0908
2 Pockoging Areo
Double line cleoronce form in
Minor pocking of Eurivit syrup 250m1.
Compounder overlook the CA line leoder check ond updote reol
reol time recording during time record during compounding.
compounding. PA Sirict implemeniotion of Good Morch 21 ,2019 Done
Documentotion prociice.
Coding personnel did not CA- Pocking personnel withdrow BPK
issue the line cleoronce ot coding section prior to pocking
ottoched in the BPK due to process Morch 21 2019 Done
not yet done on the PA- To ensure thqt BPK is olwoys
coding process of ovoiloble during process.
individuol box.

Recommendotion

( ) To ohrvoys observe Good Monufocluring Proclice/ Good Sloroge Proctice

( ) For follow-up inspeclion

Directives

For Corrective Action / Preventive Action ( CAPA)

Address the deficiencies ond submit the CAPA Plon including submission of objeclive evidence of complionce within the specified
timeline reckoned on the following doy of receipl of summory of observolionsfindings:
 INTERNAL QUALITY AUDIT REPORT Form No. OP-I0005-F02

Audil Reporl No.: QAr-2019-003

AM-EUROPHARMA CORPORATION
Audited Sile: Audit Dote(s): Morch 26,2019
Borongoy Soimsim, Colombo City, Loguno
Audited Areo(s): Liquid Areo - Premises ond Equipments Poqe: 2of3

llem Correclive Aclion / Prevenlive

Colegory Audit Findings Rool Couse Torgel Dote Remorks
No. Aclion

() Iwenty five (25) colendor doys for crilicol deficiencies

() Thirty five (35) colendors doys for mojor ond other deficiencies

The C nce-reloted Risk bosed on lhe

The complionce risk indicoled by the most
recenl deficiency profile of lhe oreo is E low No mojor or crilicoldeficiencies

E Medium I to 5 mojor deficiencies : No. Of mojors

l0 ond obove minors or others : No. Of Minors

I or more crilicoldeficiencies or more lhon 5 mojors

Complionce Mode by ihe Areo

( ) Submitted CAPA
( ) Accepted
( ) Not occepted
 *ffi@ INTERNAL QUALITY AUDIT REPORT Form No. OP-10005-F02

Audit Report No.: QAr-20r9-003

AM-EUROPHARMA CORPORATION
Audited Site: Audit Dote(s): Morch 26,2019
Boronooy Soimsim, Colombo Citv, Loouno
Audited Areo(s): Liquid Areo - Premises ond Equipments Poqe: 3of3

Item Correclive Action / Prevenlive

Colegory Audit Findings Rool Couse Torgel Doie Remorks
No. Action

Recommendotion:

Prepared by:

Noted by:
,t-
llYn'uod
Cef,erina Samonte
I
Prpduction Manager