UNICEF Prequalification of Nutrition Products · PDF filet d Request for further info from...
-
Upload
trinhnguyet -
Category
Documents
-
view
213 -
download
0
Transcript of UNICEF Prequalification of Nutrition Products · PDF filet d Request for further info from...
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
Type your title in this FOOTER area and in CAPS
2ND STAGE : SAMPLE EVALUATION
Sample evaluation
Conducted by Technical
staff in Quality or
Nutrition units
UNICEF
UNICEF’s Technical Evaluation of Nutrition Products
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
UNICEF’s Technical Evaluation of Nutrition Products
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
Type your title in this FOOTER area and in CAPS
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
Type your title in this FOOTER area and in CAPS
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
Type your title in this FOOTER area and in CAPS