Quality Assurance Policy for Reproductive Health Supplies and Services in Ethiopia
This policy outlines the quality assurance measures implemented in Addis Ababa, Ethiopia, in June 2011. It emphasizes risk management in procurement, quality approval processes, and monitoring. The achievements include the assurance of contraceptives and essential medical devices, capacity building, and the development of guidelines. The policy was developed in consultation with WHO, UNICEF, and other agencies, with a focus on ensuring compliance with QA requirements for reproductive health medicines.
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Quality Assurance Policy RHSC, SSWG Addis Ababa, Ethiopia 21 June 2011 Morten Sorensen, UNFPA PSB
Key Players Raw materials suppliers Manufacturer Quality Assurance Quality Control Laboratory National regulatory authority Procurement unit Logistics system End user
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 product Well known supplier, reputable Supplying to markets with Stringent Regulatory Authority QA monitoring: Quality assessment before entering into LTA (Qualification processes) Pre-shipment inspections / quality control
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 & IUDs Technical Review process for Female Condoms Capacity building, system strengthening national regulatory authorities and quality control laboratories Development of guidelines (CD-rom): Male Condoms & IUD specifications Female Condom generic specifications Statement on Post-shipment testing of condoms Statement on UNFPA QA system
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. 2011
QA Requirements as per new policy Contraceptives WHO/UNFPA Prequalification (condoms & IUDs) WHO Prequalification (hormonal contraceptives, oxytocics) ERP approval Internal Technical Review Committee approval Other Essential Medicines Internal Technical Review Committee approval 1. GMP compliance 2. QA of API 3. Finished product pharmacopeia monograph 4. Stability 5. Regulatory status 6. Packaging and labelling
RatingTable REGISTRAT. / MANUFACT. F.P. ANAL. REFERENCE SAMPLE / PACK. / LAB. MFG SITE GMP STABILITY API QA PHARMACOPOEIA BP/USP/Int.Ph. + Additional tests REG in an Highly Regulated Country Fully compliant With specifications TRILING. LABEL SATISFACTORY GMP AUDIT (product oriented) Report received Satisfactory Type 4 CEP 6 AVAILABLE T H E R A P E U T I C MANUF: PIC/S or eq. country REG in an Highly Regulated Country Compliant With specifications BILING. LABEL DMF SATISFACTORY GMP AUDIT (product oriented) PHARMACOPOEIA BP/USP/Int.Ph. Satisfactory Type 2+ AVAILABLE + GMP 5 MANUF: Non PIC/S or eq. country Not REG in an Highly Regulated Country MANUF : PIC/S or eq. country Compliant With specifications ENGLISH ONLY SATISFACTORY GMP AUDIT (not product oriented) IN HOUSE EQUIVALENT METHODS TF Satisfactory Type 2 4 AVAILABLE + GMP E Q U I V A L E N C E REG: country of origin (non HRC) CORRECTIONS COMMITMENT RECEIVED IN Temporarly Acceptable MINOR DEVIATIONS PRODUCER IDENTIFIED + 3 HOUSE MANUF: Non PIC/s or eq. country REG : any other country IN HOUSE < BP/USP/Int.Ph. CORRECTIONS + NEW AUDIT NEEDED UNSATISFACTORY STABILITY STUDIES 2 PRODUCER IDENTIFIED MAJOR DEVIATIONS MANUF: Non PIC/s or eq. country DEFICIENCIES TOO NUMEROUS TO HOPE RAPID CORRECTIONS NO STABILITY STUDIES AVAILABLE NOT REGISTERED. in any country CRITICAL DEFICIENCIES ANALYTICAL METHODS NOT AVAILABLE PRODUCER NOT IDENTIFIED 1 MANUF: Non PIC/S or eq. country
