RHSC SSWG Addis Ababa Ethiopia 21 June 2011 Morten Sorensen UNFPA PSB Key Players Raw materials suppliers Manufacturer Quality Control Laboratory National regulatory authority Procurement unit ID: 734809
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Slide1
Quality Assurance Policy
RHSC, SSWG
Addis Ababa, Ethiopia
21 June 2011
Morten Sorensen, UNFPA PSBSlide2
Key Players
Raw materials suppliers
ManufacturerQuality Control Laboratory National regulatory authority Procurement unit Logistics system End user
Quality AssuranceSlide3
Quality consciousness
Risk management approach to procurement:
Quality approval status of product
Consideration of known history with supplier New supplier / no or limited history / new productWell known supplier, reputableSupplying to markets with Stringent Regulatory AuthorityQA monitoring:Quality assessment before entering into LTA (Qualification processes)Pre-shipment inspections / quality controlSlide4
The scope of activities & achievements
Quality Assurance of contraceptives, other essential medicines and medical devices to support M/RH
QA Policy
approved and 1st EOI posted Prequalification scheme of Condoms & IUDsTechnical Review process for Female CondomsCapacity building, system strengthening – national regulatory authorities and quality control laboratoriesDevelopment of guidelines (CD-rom):Male Condoms & IUD specifications
Female Condom generic specifications
Statement on Post-shipment testing of condoms
Statement on UNFPA QA systemSlide5
QA Policy for RH medicines
Developed in consultation with WHO, UNICEF and other agencies
Approved March 2011, effective April 2011
EOI for hormonal contraceptives posted April 2011 Indicated interest from generic manufacturers Reviews scheduled for Sept. 2011 Target: complete review and recommendations by Dec. 2011Slide6
QA Requirements as per new policy
Contraceptives
WHO/UNFPA Prequalification (condoms & IUDs)
WHO Prequalification (hormonal contraceptives, oxytocics)ERP approvalInternal Technical Review Committee approvalOther Essential MedicinesInternal Technical Review Committee approvalGMP compliance
QA of API
Finished product pharmacopeia monograph
Stability
Regulatory status
Packaging and labelling Slide7
5
4
3
1
2
Satisfactory
Type 2+
Satisfactory
Type 2
Temporarly
Acceptable
UNSATISFACTORY
STABILITY
STUDIES
NO STABILITY
STUDIES
AVAILABLE
Satisfactory
Type 4
PHARMACOPOEIA
BP/USP/Int.Ph.
IN HOUSE
EQUIVALENT
METHODS
IN
HOUSE
IN HOUSE
<
BP/USP/Int.Ph.
ANALYTICAL
METHODS
NOT AVAILABLE
PHARMACOPOEIABP/USP/Int.Ph. +Additional tests
DMF AVAILABLE+ GMP
TF AVAILABLE+ GMP
PRODUCERIDENTIFIED +
PRODUCERIDENTIFIED
PRODUCERNOTIDENTIFIED
CEP AVAILABLE
Compliant With specifications BILING. LABEL
Compliant With specifications ENGLISH ONLY
MINOR DEVIATIONS
MAJOR DEVIATIONS
CRITICAL DEFICIENCIES
Fully compliant With specificationsTRILING. LABEL
SATISFACTORYGMP AUDIT(product oriented)
SATISFACTORYGMP AUDIT(not product oriented)
CORRECTIONS COMMITMENTRECEIVED
CORRECTIONS + NEW AUDITNEEDED
DEFICIENCIES TOO NUMEROUS TO HOPE RAPID CORRECTIONS
6
REGISTRAT. / MANUFACT.
F.P. ANAL. REFERENCE
API QA
SAMPLE/ PACK. / LAB.
STABILITY
MFG SITE GMP
REG in an HighlyRegulated CountryMANUF: Non PIC/S or eq. country
Not REG in an Highly Regulated CountryMANUF : PIC/S or eq. country
REG: country of origin (non HRC)MANUF: Non PIC/s or eq. country
REG : any other countryMANUF: Non PIC/s or eq. country
NOT REGISTERED. in any countryMANUF: Non PIC/S or eq. country
REG in an Highly Regulated CountryMANUF: PIC/S or eq. country
SATISFACTORYGMP AUDIT(product oriented)Report received
Rating Table
T
H
E
R
A
P
E
U
T
I
C
E
Q
U
I
V
A
L
E
N
C
E