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
Source: UNICEF Supply Division
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)
Source: UNICEF Supply Division
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
Scale up
• Change management
Source: UNICEF Supply Division
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
Source: UNICEF Supply Division
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
Source: UNICEF Supply Division
A QUALITY MANAGEMENT SYSTEM
FOR MNP LIFE CYCLE
Verification
Discontinuation
Improvement
Development
Monitoring
Planning and
realization of safe
products
implementation
Risk mitigation
plan or HACCP
plan
Risk/ Hazard
analysis
Validation of
processes &
control measures
Source: UNICEF Supply Division
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)
Source: UNICEF Supply Division
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
•
Source: UNICEF Supply Division
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
Source: UNICEF Supply Division
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
Source: UNICEF Supply Division
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
Source: UNICEF Supply Division
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
Source: UNICEF Supply Division
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.
Source: UNICEF Supply Division
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.
Source: UNICEF Supply Division
Thank you for your attention
Any questions?