8/8/2019 Critical Requirements Common Project 1

1/5

SR REGION API GRADE EXCIPIENTS GRADE MFG PLANT GMP STD

1

2 S. AFRICA

3 CANANDA

4 WHO PQP Inspection by WHO,GENEVA

EUMEMBER

COS grade As perPh.EurGrade withGMP certificate OR ISO ofthe MFG Pant

Inspection by EU memberwithHIGH REGULATORYSTANDARDS

COS OrDMFGrade

Pharmacopoeial grade orIn-House grade withValidation report ;andPlant with GMP certificate orISO ofMFG plant

Inspection by Referencecountry from PIC/S scheme(like Sweden, UK, Canada)

COS grade withCANADIANDMF registered.

EP/USP/BP GRADE withGMP certificate orISO9000/2 ofMFG PLANT

Inspection by referencecountry from PIC/S scheme(like Sweden,UK,Netherlands)

COS orDMFGrade(Submission ofDMF to WHO,GENEVA forevaluation &Plant inspection)

Pharmacopoeial grade orIn-house grade withVALIDATION Report;ISO 9002 orGMP certificate

8/8/2019 Critical Requirements Common Project 1

2/5

STABILITY STUDIES OF FP BE / BA REQUIREMENT

6M Long term (25/60), 6MAccelerated (40/75) 6MIntermidiate (30/65)

Against the Innovatorregistered in theEU member country

9M or12M Long term (30/65) or(30/75), 6M Accelerated(40/75)

Against S. African innovator; from S.Africa orsame innovator from otherregulated country with supporting dataabout qualitative equivalence andcomparative dissolution data

12M Long term (25/60), 6MAccelerated(40/75) 6MIintermidiate (30/65)

Against the Canandian reference product

6M or12MLong term (25/60),6M Accelerated

(40/75) 6M Intermidiate(30/75) Minimum 2 Pilot scalebatches and 1 small scalebatch

Against the Innovator registered in theEU member country/ USA/ JAPAN asperpublished competitor list.

8/8/2019 Critical Requirements Common Project 1

3/5

SR REGION API GRAD EXCIPIEN MFG PLANSTABILITYBE / BA REQUIREMENT

1 EU MEMB COS GRAAS PER P INSPECTI 6M LONG Against the Innovator registered in the EU m

2 S. AFRICACOS OR DPHARMACINSPECTI 9M LONG Against S. African innovator; from S. Africa o

3 CANANDACOS GRA EP/USP/B INSPECTI 12M LONGAgainst the Canandian reference product

4 WHO PQP COS OR DPHARMACINSPECTI 12M LONGAgainst the Innovator registered in the EU m

innovator pAustralia.

including formulation a

USP mono a regulatory system co

the corresponding inn

8/8/2019 Critical Requirements Common Project 1

4/5

mber country

r same innovator from other regulated country with supporting data about qualittative equivalence and comparativ

mber country/ USA/ JAPAN as per published competitor list.nd method of manufacture) in both countriesmparable to that in Australiavator product registered in Australia.

8/8/2019 Critical Requirements Common Project 1

5/5

e dissolution data