UNICEF s Quality Assurance System for procurement of medicines

Transcription

1 UNICEF s Quality Assurance System for procurement of medicines QA Specialist Peter Svarrer Jakobsen Joint UNICEF, UNFPA and WHO Meeting with Manufacturers and Suppliers UN City, Copenhagen 23 September 2014

2 UNICEF QA SYSTEM BASED ON: WRITTEN DOCUMENTATION SYSTEM BASED ON QUALITY MANUAL, DIVISION PROCEDURES AND CENTRE PROCEDURES PRINCIPLES OF THE WHO MODEL QA SYSTEM FOR PROCUREMENT AGENCIES FOLLOWED - TRS 986 ANNEX 3 PRINCIPLES OF PIC-S QUALITY SYSTEM REQUIREMENTS FOR GMP INSPECTORATES FOLLOWED ALL PROCUREMENT ACTIVITIES ARE CENTRALIZED IN UNICEF SUPPLY DIVISION (PROCUREMENT BY UNICEF COUNTRY OFFICES REQUIRES SPECIFIC AUTHORIZATION)

3 PRE-QUALIFICATION - MEDICINES PRODUCTS PRODUCT QUESTIONNAIRE AS IN THE WHO MODEL QA SYSTEM WHO TRS 986 SUPPLIERS REVIEW OF SUBMITTED DOCUMENTATION AND/OR GOOD MANUFACTURING PRACTICE (GMP) INSPECTIONS TO ENSURE COMPLIANCE WITH WHO GMP GUIDELINES

4 PRE-QUALIFICATION OF SUPPLIERS HOW? TECHNICAL QUESTIONNAIRE MANUFACTURING SITE (S) DEFINED DOSAGE FORMS / PRODUCTS OF INTEREST EXPORT EXPERIENCE LICENSE TO MANUFACTURE MEDICINAL PRODUCTS IS A GMP INSPECTION NEEDED?

5 GMP INSPECTIONS DECISION BASED ON THE REGULATORY ENVIRONMENT IN COUNTRY OF ORIGIN AND PRIOR EXPERIENCE OF UNICEF GMP INSPECTION BY UNICEF OR A REPRESENTATIVE SELECTED BY UNICEF CONTRACT MANUFACTURE ONLY ACCEPTED IF SUB- CONTRACTOR ALSO IS APPROVED BY UNICEF

6 GMP INSPECTIONS BY UNICEF TO CHECK COMPLIANCE WITH WHO GMP GUIDELINES 135 GMP INSPECTIONS CARRIED OUT IN COMPANIES FAILED (15%) DETAILED GMP INSPECTION REPORT FORWARDED TO COMPANY WITH REQUEST TO RESPOND WITHIN 1 MONTH ANNUAL INSPECTION PLAN IS ESTABLISHED (FREQUENCY OFTEN 2 5 YEARS)

7 GMP INSPECTIONS COLLABORATION LOCAL AUTHORITY INVITED TO PARTICIPATE JOINT INSPECTIONS WITH WHO PQ, ICRC, MSF UNICEF RELY ON WHO PQ OF VACCINES, HIV, MALARIA AND TB PRODUCTS UNICEF IS A PARTNER TO THE PHARMACEUTICAL INSPECTION COOPERATION SCHEME (PIC-S) UNICEF USE AVAILABLE INFORMATION FROM PARTNERS AND PIC/S MEMBER AUTHORITIES TO WAIVE UNICEF GMP INSPECTIONS COMPANIES THAT ARE FOUND GMP NON-COMPLIANT BY UNICEF PARTNERS SHOULD NOT CONTINUE TO SUPPLY TO UNICEF. INSTANT NOTIFICATION MUST BE PROVIDED

8 UNICEF SUPPLY DIVISION WAREHOUSE LICENSED BY THE DANISH HEALTH AND MEDICINES AGENCY: TO WHOLESALE OF MEDICINES HANDLE NARCOTIC AND PSYCHOTROPIC SUBSTANCES COMPLIANCE WITH EUROPEAN UNION GUIDELINE ON GOOD DISTRIBUTION PRACTICE (GDP) UNICEF WHOLESALE MEDICINES IT IS NOT SUPPLY UNDER A CONTRACT MANUFACTURE AGREEMENT

9 PROBLEMS AT UNICEF GOODS RECEIPT NO PACKING LIST MISSING CERTIFICATE AT GOODS RECEIPT PLEASE NOTE: UPON SHIPMENT OF THE ORDER, THE PACKING LIST AND THE RELEVANT CERTIFICATES OF ANALYSIS SHOULD BE SENT AS SEPARATE PDF FILES VIA TO THE ATTACHED FILES SHOULD NOT EXCEED 6MB UNICEF'S PURCHASE ORDER NUMBER SHOULD BE STATED ON THE SUBJECT LINE OF ALL CORRESPONDENCE. FAILURE TO COMPLY WITH THIS PROCEDURE MAY RESULT IN PAYMENT DELAYS.

10 PROBLEMS AT UNICEF GOODS RECEIPT SUB-HEADER ARIAL 18 LOOSE LABELS ON PRIMARY PACKS (TABLET CONTAINERS) NO LEAFLET OR LEAFLET NOT PACKED TOGETHER WITH THE PRIMARY PACK CERTIFICATE OF ANALYSIS DO NOT INCLUDE NAME OF MANUFACTURING SITE TO LITTLE REMAINING SHELF LIFE (OBTAIN PRIOR APPROVAL IF NEEDED FROM STAFF WHO PLACED THE ORDER)

11 UNICEF QUALITY CONTROL TESTING ANALYSIS PERFORMED ACCORDING TO AN ANNUAL PLAN BOTH WAREHOUSE SHIPMENTS AND DIRECT SHIPMENTS ARE INCLUDED EXTERNAL LABORATORIES USED FOR THE ANALYSIS (MOST ARE WHO PRE-QUALIFIED) FEW PROBLEMS OBSERVED (MAINLY MARGINALLY LOW ASSAY OR IMPURITIES)

12 TEMPERATURE CONTROL DURING SHIPMENT GDP REQUIREMENT THAT NEEDS TO BE IMPLEMENTED ALL MANUFACTURERS/SUPPLIERS WILL IN THE FUTURE BE REQUESTED TO DOCUMENT CORRECT SHIPMENT CONDITIONS AT SUPPLY TO SUPPLY DIVISION TEMPERATURES DURING DIRECT SHIPMENTS WILL ALSO NEED TO BE MONITORED

13 GMP DEFICIENCIES FROM UNICEF INSPECTIONS QUALITY MANAGEMENT QUALITY RISK MANAGEMENT NOT IMPLEMENTED HANDLING OF CHANGES AND DEVIATION ARE POOR ORGANISATION AND PERSONNEL TRAINING IN PRODUCT RELEASE POORLY DOCUMENTED TRAINING IN ASEPTIC PROCEDURES PRODUCTION CLOTHES SHOULD NOT BE WORN OUTSIDE CONTROLLED AREAS

14 GMP DEFICIENCIES FROM UNICEF INSPECTIONS FACILITIES POOR SEPARATION BETWEEN CONTROL AND NON- CONTROLLED AREAS POOR CONSTRUCTION MATERIALS (DIFFICULT TO MAINTAIN) TOILETS IN PRODUCTION AREAS POOR FLOW OF PERSONNEL FLOW, WHICH PREVENT HANDWASH AT ENTRY TO PRODUCTION AREAS RISK OF CROSS-CONTAMINATION BETWEEN PENICILLINS AND CEPHALOSPORINS DOUBLE STANDARD FACILITIES FOR LOCAL / EXPORT MARKET GENERALLY NOT ACCEPTABLE

15 GMP DEFICIENCIES FROM UNICEF INSPECTIONS EQUIPMENT HVAC NOT DESIGNED TO ENSURE A GOOD AIRFLOW IN THE AREA. AIRFLOW PATTERNS NOT KNOWN. RE-CIRCULATION OF AIR IN NON-STERILE DUSTY AREAS WITHOUT HEPA FILTRATION BOTH IN GENERAL VENTILATION AND IN SPECIFIC EQUIPMENT E.G. FLUID BED DRYERS RISK OF CROSS-CONTAMINATION DUE TO WRONG AIRFLOW DIRECTION PRODUCTION MANUFACTURING PROCESS NOT VALIDATED OR NOT FOR ALL BATCH SIZES

16 GMP DEFICIENCIES FROM UNICEF INSPECTIONS DIFFERENT API SOURCE, THAN THE ONE APPROVED BY UNICEF CONTROL OF API SOURCES AND VENDOR QUALIFICATION IS POOR API SOURCE NOT GMP COMPLIANT HANDLING OF ANALYTICAL WORKING STANDARDS NO FORMAL STABILITY REPORT FOR EACH PRODUCT ANNUAL PRODUCT REVIEW NOT TIMELY CARRIED OUT

17 UNICEF VACCINES Thank you!