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UNICEF PREQUALIFICATION OF NUTRITION PRODUCTS:

Evaluation process for product acceptance

Alison Fleet

UNICEF Supply Division, 1 July 2015

PURPOSE OF PREQUALIFICATION

Ensure that the highest possible quality goods are distributed to end-users.

Assessing the product & facility , UNICEF has an understanding of the product quality

Assurances that donor’s funds

are well spent. UNICEF

PURPOSE OF PREQUALIFICATION

Long Term agreements that can last for 2 years + 1year

Rigorous process is applied up-front as this can mean a big commitment in procurement over the duration of the LTA

UNICEF partners such as MSF and WFP inspections are shared waive a GMP inspection by UNICEF.UNICEF

INPUTS FOR PRE-APPROVAL PROCESS

• Quality Questionnaire&

• Product Questionnaire

Questionnaires

• Dossier received

• Dependant on tender

Product dossiers • Sampling

and testing

• PDIs

Test results

UNICEF

INPUTS FOR PRE-APPROVAL PROCESS

• Complaints

• Feedback & PD partners

Complaints

• Corrective

• Preventative actions

CAPA• Product

submission with bid

Sample

UNICEF

Info not provided

Yes

yes yes

Yes

No No

No

Suppliers dossiers recived

Contracting request for

evaluation

Dossier screened for essential

documents

EssentialDocuments provided?

1st stage : Dossier

evaluation andcompliance

assessment (tests/complain

ts)

Product not accepted

2nd stage: Sample evaluation & GMP compliance

Complience with spec?Vendor

GMP status

follow-upwith

suppliers

Spread-sheet developed

Sample Acceptable?

Productnot accepted

Product not accepted

Evaluationreport

developed

Evaluaitonreport included in contract recomendation

spec

ific

atio

n

dev

elo

pm

ent

& in

vite

e lis

t co

mp

lied

Request for further info from

supplier

Inspection

requested to QAC

Product approved

1st

2nd

SPECIFICATION UPDATES

UNICEF

Type your title in this FOOTER area and in CAPS

bids

quality issues

ongoing improvements

• Updates to specifications for nutritional products supplied by UNICEF are normally conducted prior to procurement bids

• Quality issues can trigger a specification update

• New evidence

• New regulations

INPUTS FOR SPECIFICATION DEVELOPMENT

Guidelines and protocols eg:- WHO- FANTA- UN agency

publications

Suppliers

End users & those

working closely with

program beneficiarie

s

UNICEF Inter-

agency partners

Complaints feedback and

surveys

Experts and

expert panels

UNICEF’ S ACTIVITIES ON DEVELOPING SPECIFICATIONS

Unicef aims to provide products of good quality, that can meet global needs for humanitarian aid

Since 2012, specifications that have had major reviews include:

- RUTF

- F 75 & F100

- Supplementary foods (MQ-LNS & RUSF)

- Micronutrient Powders (MNPs)

- Anthropometric equipment

- Testing equipment for nutrients (Portable photometers and reagents)

PRODUCT EVALUATION PROCESS

UNICEF

1ST STAGE : QUESTIONNAIRES AND DOSSIERS REVIEW

Questionnaires and Dossiers

• Completeness

Specification compliance

• CoA, stability data and manufacturers specification

Certification

• Licencing and certification of the facility

UNICEF

Stability data

Address of manufacturing facility (exact location or Block of site; and country of manufacture), packing facility, supply of intermediate materials are often not provided, or the information is unclear

Questionnaires submitted are incomplete (eg form of vitamin and minerals is needed)

Fully complete analysis (CoA) of all parameters of the product specification are not submitted for a batch

Stability data submitted does not follow a scientific basis; has missing time points, or is not conducted in a controlled way (temperature/humidity)

UNICEF

UNICEF’s Technical Evaluation of Nutrition Products

Common issues with dossiers:

COMMON ISSUES WITH DOSSIERS:

Test reports or documentation are not in English

Suppliers specifications, test reports & stability

data are often missing information such as :

date batch number details, company nameReference specification parametersanalytical limits from the lab

UNICEF


2ND STAGE : SAMPLE EVALUATION

Sample evaluation

Conducted by Technical

staff in Quality or

Nutrition units

UNICEF


If the documentation submitted meets UNICEF criteria, we conduct a sample evaluation

Depending on the product, certain tests are performed on the products

All products are visible inspected for their standard of workmanship and quality

All food items undergo a organoleptic test

Anthropometric equipment is tested for functionality and accessories such as slings and weighing trousers are machine washed to test shrinkage

UNICEF


2nd stage of Product evaluation : Sample Evaluation

2ND STAGE OF PRODUCT EVALUATION : SAMPLE EVALUATION

sample evaluation

• If the documentation submitted meets UNICEF criteria

tests• Depending on the product

eg organoleptic test

visible inspection

• workmanship and quality

functionalityUNICEF

COMMON ISSUES WITH SUBMITTED SAMPLES

Samples are delivered late

Products have visible defects such as :Visible product faults

Packaging difficult to open for the end user

Oil leaking from lipid based products

Labelling not to specifications

Taste and texture issues

Product samples for change approvals arrive with no clear explanation of the change made, or the batch details and associated test reporting.

PRODUCT ACCEPTANCE

If a product is accepted for supply, it is the product, along with its documentation that is accepted.

This is the supplier’s product that the contract agreement is in reference to.

The LTA contains two Technical references :

oSpecification

oTechnical requirements

UNICEF


TECHNICAL REQUIREMENTS IN LTAS

UNICEF has updated the Technical requirements for LTAs :

Product composition and / or process changes

UNICEF should be notified and approve of any changes in the formulation, ingredients, excipient sources, finished product specifications and/or major manufacturing process changes that has been included in the original bid submission.

UNICEF


TECHNICAL REQUIREMENTS - LTAS

Shelf life requirements:

Unless specifically authorised in writing by UNICEF, products must be of fresh production e.g., remaining 80% of shelf life at the time of delivery. Shelf life and storage conditions must be confirmed by stability studies conducted according to the standard specified ….attached or referred to in the bid document.

SUMMARY

Technical evaluation for nutrition products is performed prior to each bid and prior to inspections

Correct documentation submission is a pre-requisite to supplying UNICEF

Submitting a poor quality sample or having unresolved complaints at the time of evaluation will likely lead to non – acceptance

Changes to an approved product (as per the LTA) need to be communicated to UNICEF and sometimes approved

UNICEF

THANK YOU

UNICEF
