UNICEF s Quality Assurance System for Procurement of Micronutrient Powders (MNP) Nutrition Supplier Meeting, June 30, 2015 Dimitris Catsoulacos Quality Assurance Specialist
PRESENTATION OVERVIEW Quality Standards for MNP Quality Management System and MNP Lifecycle UNICEF s Quality Assurance System Pre-qualification Activities and Inspections Most frequently encountered deficiencies
QUALITY STANDARDS Codex Alimentarius - Recommended International Code of Practice. General Principles of Food Hygiene CAC/RCP 1-1969, Rev. 4-2003 ISO 22000: 2005 Food safety management systems Requirements for any organization in the food chain ISO 22004: 2014 Food safety management systems Guidance on the application of ISO 22000 Quality Manual on Micronutrient Powders UNIDO HF-TAG "Good Manufacturing Practices for Pharmaceutical Products" (WHO Technical Report Series 986)
A QUALITY MANAGEMENT SYSTEM FOR MNP LIFE CYCLE Product Development Manufacturing and Distribution Product Discontinuation Product Development Product design selection of appropriate starting and packaging material in order to ensure adherence to pre-defined quality and safety criteria Process design and scaling up consistent delivery of the intended performance Analytical method development Establishment of HACCP plan Stability studies Change management Scale up
A QUALITY MANAGEMENT SYSTEM FOR MNP LIFE CYCLE Product Development Manufacturing and Distribution Product Discontinuation Manufacturing - Qualification of suppliers - Acquisition and control of materials - Qualification of facilities - Verification/calibration utilities, and equipment - Production (including packaging and labelling) and change management - Quality control and assurance - Release - On-going stability - Storage - Distribution - Technology transfer
A QUALITY MANAGEMENT SYSTEM FOR MNP LIFE CYCLE Product Development Manufacturing and Distribution Product Discontinuation Production Discontinuation - Retention of documentation - Sample retention - Continued product assessment and reporting, if appropriate
A QUALITY MANAGEMENT SYSTEM FOR MNP LIFE CYCLE Discontinuation Verification Improvement Monitoring Development Planning and realization of safe products implementation Risk/ Hazard analysis Risk mitigation plan or HACCP plan Validation of processes & control measures
UNICEF S QUALITY ASSURANCE SYSTEM Adherence to WHO Model Quality Assurance System for Procurement Agencies MQAS - TRS 986 Annex 3 Documentation system in place - Quality manual - Division procedures - Centre procedures Generally procurement activities are centralized in UNICEF Supply Division (procurement by UNICEF country offices requires authorization)
PRE-QUALIFICATION ACTIVITIES Micronutrient Powders Interagency Food Product Questionnaire Manufacturers/ Suppliers Review of Good Manufacturing Practice information: - Technical Questionnaire - Manufacturing license - ISO Certification or equivalent - Site Master File or equivalent - Recent Inspection Reports Contract Manufacture is accepted if both the manufacturer and the sub-contractor are approved by UNICEF
GMP INSPECTIONS Decision making process - Evaluation of manufacturing information - Regulatory framework in the country where the manufacturer is located - Prior UNICEF experience Plan, Prepare, Perform - Agree on inspection date - Request Site Master File Manufacturing License - Provide inspection plan in advance - Extend invitation to local authority - Inspection performed by UNICEF inspector(s) or qualified UNICEF representative(s) - Verify compliance with ISO 22000 or GMP - Detailed inspection report issued within 3 weeks of inspection date - Manufacturer s response/capa plan expected within 1 month of inspection report receipt. - Official closing letter
MOST FREQUENTLY ENCOUNTERED DEFICIENCIES (1) QUALITY MANAGEMENT AND DOCUMENTATION - HACCP plan not updated - Poor handling of non conformities - Weak investigations poor corrective action implementation - Prerequisite programmes (PRPs) not documented - Inadequate control on issue, distribution and review of procedures
MOST FREQUENTLY ENCOUNTERED DEFICIENCIES (2) ORGANIZATION AND PERSONNEL - Top management role and responsibilities not adequately defined - No evaluation of training sessions Missing records FACILITIES - Storage conditions not monitored or not defined - Inappropriate construction materials poor maintenance
MOST FREQUENTLY ENCOUNTERED DEFICIENCIES (3) EQUIPMENT - UTILITIES - Inappropriate design and qualification of HVAC system Unknown airflow patterns/ differential pressure cascade - Incomplete verification/ qualification of production equipment PRODUCTION - Manufacturing process not validated or not for all batch sizes - Metal detectors not installed - Incomplete batch record documentation - Campaign working - Cleaning not defined - Line clearance not documented - No technical agreement for contract manufacturing activities
MOST FREQUENTLY ENCOUNTERED DEFICIENCIES (4) QUALITY CONTROL - Incomplete analytical method validation - Poor qualification and control of API suppliers - Limited testing on raw materials and finished product - Stability data not in support of current formulation and packaging - Finished product specifications and release criteria not defined.
INTERNATIONAL COLLABORATION ON INSPECTIONS UNICEF shares inspection reports and information with international partners and vice versa Inspection reports and information from partners is used to prioritize and in some cases to waive GMP inspections It is expected that manufacturers that are found GMP non-compliant by UNICEF partners inform UNICEF immediately.
Thank you for your attention Any questions?