dimitris catsoulacos - unicef qa system for procurement of mnp's

UNICEF’s Quality Assurance System

for Procurement of Micronutrient

Powders (MNP)

Nutrition Supplier Meeting, June 30, 2015

Dimitris Catsoulacos – Quality Assurance Specialist

Source: UNICEF Supply Division

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• 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

Product Development

Manufacturing and

Distribution

Product Discontinuation

Scale up



FOR MNP LIFE CYCLE

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

Product Development

Manufacturing and

Distribution




FOR MNP LIFE CYCLE

Production Discontinuation- Retention of documentation

- Sample retention

- Continued product assessment and reporting, if appropriate

Product Development

Manufacturing and

Distribution




FOR MNP LIFE CYCLE

Verification

Improvement

Planning and realization of safe

products

Risk/ Hazard analysis

Validation of processes &

control measures

Risk mitigation plan or HACCP

plan

implementation

Monitoring

Discontinuation

Development


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 ACTIVITIESMicronutrient 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 informationwith international partners and vice versa

Inspection reports and information from partners isused to prioritize and in some cases to waive GMPinspections

It is expected that manufacturers that are foundGMP non-compliant by UNICEF partners informUNICEF immediately.

Thank you for your attentionAny questions?

dimitris catsoulacos - unicef qa system for procurement of mnp's

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