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Quality Assurance Policy Quality Assurance Policy

Quality Assurance Policy - PowerPoint Presentation

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Quality Assurance Policy - PPT Presentation

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

country quality pic 2011 quality country 2011 pic reg countrymanuf product condoms contraceptives stability regulatory amp specifications review policy system type satisfactorygmp

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Presentation Transcript

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