SR REGION API GRADE EXCIPIENTS GRADE MFG PLANT GMP STD

1 EU COS grade As per Ph.Eur Grade with Inspection by EU member with

MEMBER GMP certificate OR ISO of HIGH REGULATORY
the MFG Pant STANDARDS

2 S. AFRICA COS Or DMF Pharmacopoeial grade or Inspection by Reference

Grade In-House grade with country from PIC/S scheme
Validation report ;and (like Sweden, UK, Canada)
Plant with GMP certificate or
ISO of MFG plant

3 CANANDA COS grade with EP/USP/BP GRADE with Inspection by reference

CANADIAN GMP certificate or ISO country from PIC/S scheme
DMF registered. 9000/2 of MFG PLANT (like Sweden,UK,Netherlands)

4 WHO PQP COS or DMF Pharmacopoeial grade or Inspection by WHO,GENEVA

Grade In-house grade with
(Submission of VALIDATION Report;
DMF to WHO, ISO 9002 or GMP certificate
GENEVA for
evaluation &
Plant inspection)
STABILITY STUDIES OF FP BE / BA REQUIREMENT

6M Long term (25/60), 6M Against the Innovator registered in the

Accelerated (40/75) 6M EU member country
Intermidiate (30/65)

9M or 12M Long term (30/65) or Against S. African innovator; from S.

(30/75), 6M Accelerated Africa or same innovator from other
(40/75) regulated country with supporting data
about qualitative equivalence and
comparative dissolution data

12M Long term (25/60), 6M Against the Canandian reference product

Accelerated(40/75) 6M
Iintermidiate (30/65)

6M or 12M Long term (25/60), Against the Innovator registered in the

6M Accelerated EU member country/ USA/ JAPAN as
(40/75) 6M Intermidiate per published competitor list.
(30/75) Minimum 2 Pilot scale
batches and 1 small scale
batch
SR REGION API GRADEEXCIPIENTS
MFG
GRADE
PLANT
STABILITY
GMP STDBE
STUDIES
/ BA REQUIREMENT
OF FP

1 EU MEMBER
COS GRADE
AS PER PHARM
INSPECTION
EUR 6M
GRADE
BY
LONG
EUWITH
MEMBER
TERM
Against
GMP
(25/60),
the
WITH
CERTIFICATE
Innovator
6M
HIGH
ACELERATED(40/75)
registered
REGULATORY
OR ISOinOF
theTHE
STANDARDS
EU &member
MFG
6M INTERME
PLANT
country

2 S. AFRICA COS OR DMF

PHARMACOPIAL
GRADEINSPECTION
GRADE
9MBY
LONG
OR
REFERENCE
IN-HOUSE
TERM
Against(30/65)
S.
GRADE
COUNTRY
African
ORWITH
(30/75),
innovator;
FROM
VALIDATION
& PIC/S
from
6M ACELERATED(40/75)
S.SCHEME
Africa
REPORTor (like
same
;AND
Sweden
innova
PLA

3 CANANDA COS GRADE

EP/USP/BP
WITH CANADIAN
INSPECTION
GRADE DMF
WITH
12MBY
REGISTERED.
LONG
GMP
REFERENCE
Against
CERTIFICATE
TERM (25/60),
the
COUNTRY
Canandian
OR
6MISO
ACELERATED(40/75)
FROM
reference
9000/2
PIC/S
OFproduct
THE
SCHEME
MFG
& 6M
(like
PLANTINTERM
Sweden

4 WHO PQP COS OR DMF

PHARMACOPIAL
GRADEINSPECTION
(SUBMISSION
GRADE
12MBY
OR
LONG
OF
WHO,GENEVA
IN-HOUSE
DMF
Against
TERM
TO WHO,
(25/60),
the
GRADE
correspondingInnovator
GENEVA
that 6M
WITH
ACELERATED(40/75)
strength
the registered
VALIDATION
FOR
formulation
innovator
of EVALUATION
a leading inthe
the
ofcompany REPORT;
EU that
brand member
product&&6M
itPLANT
ISO
INTERM
(normally
used country
9002
markets
istheINS
the th
s
innovator product)
Australia.
as marketed
including
dissolution medium in
formulation
The reference Australia
should product and method
be that described
is registeredof
in
USP monograph,
a regulatory
used inif the
onebioequivalence
system
exists. comparable
studytoart
the corresponding innovator produc
in the EU member country

m S. Africa or same innovator from other regulated country with supporting data about qualittative equivalence and comparative dissolution

in the EU that
company member country/
it markets theUSA/
sameJAPAN
productas peris,
(that published
identicalcompetitor list.
in all respects,
ormulation and method of manufacture) in both countries
rence product is registered in and obtained from a country with
erybioequivalence
system comparable
studyto that
are in Australiaidentical to those in
qualitatively
ponding innovator product registered in Australia.
d comparative dissolution data