Quality Assurance Policy 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 Logistics system End user Quality Assurance

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 1 st 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 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

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 PHARMACOPOEIA BP/USP/Int.Ph. + Additional tests DMF AVAILABLE + GMP TF AVAILABLE + GMP PRODUCER IDENTIFIED + PRODUCER IDENTIFIED PRODUCER NOT IDENTIFIED CEP AVAILABLE Compliant With specifications BILING. LABEL Compliant With specifications ENGLISH ONLY MINOR DEVIATIONS MAJOR DEVIATIONS CRITICAL DEFICIENCIES Fully compliant With specifications TRILING. LABEL SATISFACTORY GMP AUDIT (product oriented) SATISFACTORY GMP AUDIT (not product oriented) CORRECTIONS COMMITMENT RECEIVED CORRECTIONS + NEW AUDIT NEEDED 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 Highly Regulated Country MANUF: Non PIC/S or eq. country Not REG in an Highly Regulated Country MANUF : PIC/S or eq. country REG: country of origin (non HRC) MANUF: Non PIC/s or eq. country REG : any other country MANUF: Non PIC/s or eq. country NOT REGISTERED. in any country MANUF: Non PIC/S or eq. country REG in an Highly Regulated Country MANUF: PIC/S or eq. country SATISFACTORY GMP AUDIT (product oriented) Report received Rating Table THERAPEUTICEQUIVALENCETHERAPEUTICEQUIVALENCE