Post on 26-Aug-2020
1
Experience with obtaining GMP certification and WHOprequalification
programme
V. FaillatProux
Mumbai September 29, 2009
2
COARSUCAM / ASAQ Winthrop
To simplify treatment regimens
For a correct and safe use of the product
To ensure treatment effectiveness and prevent future resistance to ACT
ArteSunate + AmodiaQuine, a fixeddose combination
3
A fixed dose combination adapted to patients needs
3 strengths
25mg/67.5mg 100mg/270mg50mg/135mg
4
A fixed dose combination adapted to patients needs
Packed in 4 types blister
5
A fixed dose combination adapted to patients needs
for 4 patients groups
INFANT≥4.5kg to <9 kg (2 11 months)
TODDLERS≥9kg to <18kg(1 to 5 years)
CHILDREN≥18kg to <36kg(6 to 13 years)
ADOLESCENTADULT≥36kg
(14 years and above)
6
COARSUCAM Impact Malaria
COARSUCAM
Artesunate Amodiaquine Winthrop
2 brandnames
7
ASAQ is registered in 25 endemic countries
Registration status
And prequalified since October 2008
8
Presubmission meeting: Dec. 2006
Submission : Feb. 2007First round of questions : Jul. 2007
Second round of question: May 2008Third round of questions : Aug. 2008Fourth round of questions : Oct. 2008
Prequalification : 14 Oct. 2008
The prequalification and GMPcertification experience
Inspection: Jun. 2007New inspection Jan. 2008GMP publication : Feb. 2008
9
It’s not finished !
10
But it is not
finished !
11
Request for WHOPAR applicant contribution: October 2008
First round of questions/modifications : January 2009
Second round of questions/modifications: February 2009
Third round of questions/modifications : February 2009
Fourth round of questions/modifications: March 2009
WHOPAR final version 31 March 2009
The prequalification and GMPcertification experience
12
In case of any modification, the file should be updated and reviewed by the WHO
Every 5 years, requalification
The prequalification and GMPcertification experience
13
The involvement of the company/employees in such process
The importance of early meeting with WHO to confirm points not cover by the current guidelines
The importance of the presubmission meeting
The prequalification experienceLessons learned
14
A long process due to the product status fixed dose combination never prequalified prequalification process adapted to generics or products
already registered by a stringent authority
A long process but with quick review times
A long process justified by the high quality level requirements on both dossier and inspection
The prequalification experience Lessons learned
15
Take care of long process that may open the door to parallel procedures without full guarantee (ERP)
Documentation required not always clearly defined
The prequalification experience Lessons learned
16
File submitted under CTD format
Additional format report PQIF/BTIF
APIMF process
Risk Management Plan
The prequalification experienceThe content of the file
17
Lessons learned:
–Close link between inspection and file assessment, not clear in the procedure => data or documents not required in any guidance
–Requirement of specific reports (time consumming)
–APIMF but no information about the status of the API manufacturer file during the process
–Be creative
The prequalification experienceThe content of the file
18
Prequalification is not a marketing authorization, nor a manufacturing authorization, nor an importation
licence.
Legal and required authorizations/GMP certifications should be obtained additionally country by country.
It is not a key to open regulations doors.
The prequalification experience
19
This may lead to difficulties:
Artemisinin: starting material status in the PQ file, but for some authorities GMP status is required to
import artemisinin.
Requirements from WHO to update leaflet, but variation or notification should be applied in each country.
Management of the various inspections
The prequalification experience
20
Thank you for your attention