Annex B - Terms of Reference for Laboratory Services 1.€¦ · A pharmaceutical product is generally tested either against its compendial specifications [i.e. The International Pharmacopoeia

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United Nations Children’s Fund Telephone +45-45 33 55 00

Supply Division Facsimile +45-35 26 94 21

Oceanvej 10-12 E-mail: [email protected]

DK-2150 Copenhagen Ø www.unicef.org/supply

Denmark

Annex B - Terms of Reference for Laboratory Services

1. Background

As part of the UNICEF procurement process, risk based sampling and testing of purchased pharmaceuticals and nutrition products as well as bednets should be carried out in order to ensure that products comply with their predefined specifications. Different types of testing may be necessary for the various commodity groups purchased by UNICEF. Since UNICEF Supply Division (SD) does not have a laboratory performing chemical, microbiological and sterility testing; these services should be contracted to appropriately qualified external laboratories.

A pharmaceutical product is generally tested either against its compendial specifications [i.e. The International Pharmacopoeia (Ph. Int.), The British Pharmacopoeia (BP), The United States Pharmacopoeia (USP)] or against its in-house approved specifications. Testing of nutrition products consists principally of safety-driven microbiological testing and quantitative compliance. Microbiological testing ensures absence of pathogenic microorganisms while quantitative testing assesses the specified composition in relation to nutrition values (e.g. proteins and fat) and micronutrient levels for vitamins and minerals. Chemical testing of bednets focuses on qualitative and quantitative analysis of the embedded insecticide and mechanical testing.

A sampling and testing plan for pharmaceutical and nutrition products is elaborated on an annual basis. In 2014 UNICEF Supply Division established LTAS with WHO pre-qualified laboratories for quality control testing of pharmaceutical products and bednets and with ISO 17025 certified laboratories for microbiological and composition testing of nutrition products.

2. Purpose & Expected results

The purpose of this RFPS is to establish Long Term Arrangements for Services (LTA-S) with successful proposer(s) for laboratory testing of samples as defined in Section 3 of this TOR on the basis of pre-identified fees. Proposals are thus requested from qualified and reputable laboratories with demonstrated qualifications, capacity and experience across the categories of services provided. It is expected that 60-70 pharmaceuticals will be tested annually against their approved specifications while an average of 1000 RUTF batches and 50 batches of therapeutic milk are expected to be tested for microbial contamination. It is also expected that 40-50 tests of nutrition products in relation to their compliance with the nutrition values (protein, fat and micronutrients) will be carried out annually. It is projected that the number of insecticide content tests on bednets will be around 60 per year. The specific quantities expected for each test are further detailed in Appendix IV attached. Due to an increase in testing of nutrition products for Salmonella and Enterobacteriacea, and possibly follow-up testing for presence of Chronobacter spp., it is a requirement for laboratories to have sufficient capacity for microbiological testing. It is also crucial for laboratories to have the ability to perform all the requested analyses in a timely manner and promptly deliver analytical results.

3. Description of the assignment

LOT I: PHARMACEUTICALS – BEDNETS Analytical testing for pharmaceuticals will be performed against compendial specifications [i.e. The International Pharmacopoeia (Ph. Int.), The British Pharmacopoeia (BP), The United States Pharmacopoeia (USP)] or against approved in-house specifications. The analytical testing for bednets is limited to an HPLC method measuring insecticide concentration as well as mechanical testing. Sterility testing of pharmaceutical products should take place in accordance with compendial methods.

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This is an indicative list of pharmaceutical products tested in 2016 which constitutes the basis for the Financial Proposal requested in Appendix IV. It is expected that the number of products to be tested per year will remain the same. However, UNICEF reserve the rights to request quotation for Ad-hoc testing of other pharmaceutical products from the awarded LTA holder(s).

Amoxicillin 500mg/Clavulanic acid125mg pac-15 Ceftriaxone pdr/inj 1g vial/BOX-10

Paracetamol 125mg/5ml or.liq/BTL-60ml Phytomenadi. 10mg/ml inj.1ml amp./BOX-10

Ketamine inj 50mg/ml 10ml vial/BOX-25 Sulfadox+Pyrimeth 500+25mg tabs/PAC-1000

Miconazole 10mg Muco Adhesive tb/PAC-350 Hydrochlorothiazide 25mg tabs/PAC-100 BP

Paracetamol 500mg tabs/PAC-100 BP Amoxici.pdr/oral sus 125mg/5ml/BOT-100ml

Sulf.800mg+Trimet.160mg tabs/PAC-100 BP Furosemide inj 10mg/ml 2ml amp/BOX-10

Tetracycline eye ointment 1%/TBE-5g Erythro.pdr/oral sus 125mg/5ml/BOT-100ml

Sulf.100mg+Trimet.20mg tabs/PAC-100 Epinephrine inj 1mg/ml 1ml amp/BOX-10

Ferrous sulp.oral sol. 125mg/ml/BOT-30ml USP Amox.500mg+Clav.acid125mg tabs/PAC-15

Folic acid 5mg tabs/PAC-1000 BP Amoxicillin 500mg tabs/PAC-100

Magn.trisilicate compound tabs/PAC-1000 BP Hydralazine pdr/inj 20mg amp/BOX-5

Thiamine 50mg tab/pac-100 LPV/r 200+50mg heat/st tabs/PAC-120

Methylergom. inj 0.2mg/ml 1ml amp/BOX-10 3TC300mg+TDF300mg tabs/PAC-30

Clotrimazole 500mg vag.tabs/applicator BP Mebendazole 100mg chewable tabs/PAC-100

Ascorbic acid 250mg tabs/PAC-1000 Naloxone inj 400mcg/ml 1ml amp/BOX-10

Erythromycin 250mg tabs/PAC-100 Silver Sulfadiaz. 1% cream 50g unsterile

Sul.200mg+Trim.40mg/5ml or.sus/BOT-100ml Sulf.400mg+Trimet.80mg/pac-500 USP

ORS fl.1Lx2+ Zinc 20mg 10tabs.kit/PAC Artesunate pdr./inj. 60mg vial/BOX-1

Gentamicin inj 10mg/ml 2ml amp/BOX-50 Amoxicillin 500mg disp.tab/PAC-100

Povidone iodine sol 10 %, 500ml Sulf.400mg+Trimet.80mg/pac-500 USP

Doxycycline 100mg tabs/PAC-100 Zinc 20 mg dispersible teblets/pac -100

Methylergom. inj 0.2mg/ml 1ml amp/BOX-10 ORS fl.1Lx 2Zinc 20mg 10tabs.kit/PAC

Chlorhexidine conc. sol. 5%/BOT-1000ml Chlorhex.diglu.7.1% gel cord.c.TBE/20g

Metronidazole 500mg tabs/PAC-1000 Artemether 20mg + Lumefantrine 120 tab/18/PAC 30

Ciprofloxacin 500mg tabs/PAC-10 Artemether 20mg + Lumefantrine 120 tab/24/PAC 30

Silver Sulfadiaz. 1% cream 50g unsterile Chloroquine base 50mg/5ml oral liquid, 60 ml

Amoxicillin 250mg tabs/PAC-1000 Chloroquine Phosphate teb 150 mg/pac 100

Ceftriaxone pdr/inj 250mg vial/BOX-50

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Testing of bednets should be performed against the following specifications:

Mechancial test results:

Fabrication (Warp Knitted)

Fiber composition (100% Polyester)

Linear density (100 + 5 denier)

Number of filaments

Mesh size (> 156)

Area weight (40 + 4 gsm)

Dimension stability (+ 5)

Warp (%)

Weft (%)

Netting bursting strength (> 350 kPa)

Seam strength (> 350)

Inner seam (kPa)

Outer seam (kPa)

Flammability Classification (Class 1)

Chemical test results:

Average Deltamehtrin content (45 mg/m2)

or alternative

Average Permethrin content (20 + 3 g/kg) LOT II: NUTRITION PRODUCTS

A-Ready to Use Therapeutic Foods (RUTF) Analytical testing for RUTF should be performed against the following specifications:

Nutritional composition per 100 g of RUTF paste

Moisture content 2.5% maximum

Water activity 0.6 maximum

Energy 520-550 kcal

Proteins 10-12% total energy

12.8-16.2% by weight

Lipids 45-60% total energy 25.8-36.3% by weight

n-6 fatty acids 3-10% total energy

n-3 fatty acids 0.3-2.5% total energy

Trans-fatty acids <3% total fat

Fibre <5%

Sodium 290 mg maximum

Potassium 1100-1400 mg

Calcium 300-600 mg

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Phosphorous* 300-600 mg

Magnesium 80-140 mg

Iron 10-14 mg

Zinc 11-14 mg

Copper 1.4-1.8 mg

Selenium 20-40 mcg

Iodine 70-140 mcg

Vitamin A (Retinol Equivalent) 0.8-1.1mg RE

Vitamin B1(Thiamine) 0.5 mg minimum

Vitamin B2(Riboflavin) 1.6 mg minimum

Vitamin B3(Niacin) 5 mg. minimum

Vitamin B5(Pantothenic acid) 3 mg minimum

Vitamin B6(Pyridoxine) 0.6 mg minimum

Vitamin B7(Biotin) 60 mcg minimum

Vitmain B9(Folic acid) 200 mcg minimum

Vitamin B12(Cyanocobalamin) 1.6 mcg minimum

Vitamin C(Ascorbic acid) 50 mg minimum

Vitamin D(Cholecalciferol) 15-20 mcg

Vitamin E(Tocopherol) 20 mg minimum

Vitamin K(Phytonadione) 15-30 mcg

* Expressed in terms of non-phytate Phosphorus B-Ready to Use Supplementary Foods (RUSF) Analytical testing for RUSF should be performed against the following specifications:

Nutritional composition per 100 g of RUSF paste


Energy 540 kcal

Proteins 12.5-16.5 g/100g

Lipids 28-37 g/100g

n-6 fatty acids >4.5% total energy

n-3 fatty acids >0.5% total energy

Trans-fatty acids <3% total fat

Fibre <5%

Sodium 290 mg maximum


Calcium 540-755 mg

Phosphorous* 460-755 mg

Magnesium 150-225 mg

Iron 10-16 mg

Zinc 11-19 mg

Copper 0.5-2.0 mg

Selenium 19-49 mcg

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Iodine 80-190 mcg

Vitamin A (Retinol Equivalent) 1080-1620 mcg RE

Vitamin B1(Thiamine) 0.5 mg minimum

Vitamin B2(Riboflavin) 2.0 mg minimum

Vitamin B3(Niacin) 13.5 mg minimum

Vitamin B5(Pantothenic acid) 2.5 mg minimum

Vitamin B6(Pyridoxine) 1 mg minimum

Vitamin B7(Biotin) 11 mcg minimum

Vitmain B9(Folic acid) 215 mcg minimum

Vitamin B12(Cyanocobalamin) 2.5 mcg minimum

Vitamin C(Ascorbic acid) 80 mg minimum

Vitamin D(Cholecalciferol) 11-32 mcg

Vitamin E(Tocopherol) 16 mg minimum

Vitamin K(Phytonadione) >27 mcg

* Expressed in terms of non-phytate Phosphorus F75 Therapeutic diet Analytical testing for F75 Therapeutic diet should be performed against the following specifications: Nutritional composition per 100 g

Moisture content 4% maximum

Solubility index 0.5 ml maximum

Burnt particles 15 max

Energy 425-465 kcal

Protein 4-7% of total energy

Carbohydrate 57-69% of total energy Lactose max. 7.5 g

Lipids 25-35% of total energy n-6 fatty acid 3 -10% of total energy

n-3 fatty acid 0.3- 2.5% of total energy Sodium 100mg maximum


Calcium 300 – 600 mg

Phosphorus 300 – 600 mg

Magnesium 48 - 64 mg

Iron 0 – 0.3 mg

Zinc 11 - 18 mg

Copper 1.4 – 1.8 mg

Selenium 20 - 40 µg

Iodine 70 - 140 µg

Vitamin A 0.8 – 1.7 mg

Vitamin D3 15 – 30 µg

Vitamin E 20 - 40 mg

Vitamin K 15 µg min.

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Thiamine 0.5 mg minimum

Riboflavine 1.6 mg minimum Ascorbic acid 50 mg minimum

Vitamin B6 0.6 mg minimum

Vitamin B12 1.6 µg minimum

Folic acid 200 µg minimum

Niacin 5 mg minimum

Pantothenic acid 3 mg minimum Biotin 60 µg minimum

F100 Therapeutic diet Analytical testing for F100 Therapeutic diet should be performed against the following specifications: Nutritional composition per 100 g


Solubility index 1 ml maximum

Ash max. 4%

Burnt particles 15 max

Energy 520-550 kcal

Protein 10-12% of total energy

Carbohydrate 57-69% of total energy Lactose 21-23 g

Lipids 45-60% of total energy n-6 fatty acid 3 -10% of total energy

n-3 fatty acid 0.3- 2.5% of total energy Sodium 290mg maximum


Calcium 300 – 600 mg

Phosphorus 300 – 600 mg

Magnesium 80-140 mg

Iron 0 – 0.3 mg

Zinc 11 - 14 mg

Copper 1.4 – 1.8 mg

Selenium 20 - 40 µg

Iodine 70 - 140 µg

Vitamin A 0.8 – 1.7 mg

Vitamin D3 15 – 30 µg

Vitamin E 20 - 40 mg

Vitamin K 15 µg min.

Thiamine 0.5 mg minimum

Riboflavine 1.6 mg minimum Ascorbic acid 50 mg minimum

Vitamin B6 0.6 mg minimum

Vitamin B12 1.6 µg minimum

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Folic acid 200 µg minimum

Niacin 5 mg minimum

Pantothenic acid 3 mg minimum Biotin 60 µg minimum

C-UNICEF proposed testing of RUTF:

Microorganism n C M M Class Plan

Salmonella 30 0 0/25 g n/a 2 Enterobacteriaceae* 10 2 <10/g 100/g 3

*Testing 10 samples of 10 g for EB, 8 of which should contain 10 or less cfu/g and 2 of which may contain up to 100 cfu/g. n is sample size, c is the maximum allowable number of defective sample units in a 2-class plan or marginally acceptable sample units in a 3-class plan, m is a microbiological limit which, in a 2-class plan, separates good quality from defective quality or, in a 3-class plan, separates good quality from marginally acceptable quality, M is a microbiological limit which, in a 3-class plan, separates marginally acceptable quality from defective quality

The analytical sample size for Salmonella testing is 25 gram. Number of sachets are 30. 25 gram from 15 sachets are pooled in a sample and tested for absence in 375 gram twice. The result are to be reported as absence in 325 gram twice on the same certificate of analysis. ISO method 6579 should be used.

The analytical sample size for Enterobacteriacea testing is 10 gram (from 10 individual sachets). The results are to be reported on one certificate together with the results from the salmonella testing. ISO method 21528 should be used.

In case Enterobacteriaceae is found above 10/gram (but still within the above limit) then additional testing presence of Chronobacter spp must be carried out. The limit for presence of Chronobacter spp must then be <10/gram. (In-house method as ISO method 22964 only is used for testing absence/presence of Chronobacter spp).

Aflatoxin should in addition be tested to verify a maximum limit of 5 ppb though the limit is 10 ppb. Sample size 250 gram (3 sachets). In 2016 UNICEF implemented ICMSF’s recommendation regarding Salmonella testing on RUTF by increasing the sample size (n=30) – ICMSF Case 18

D-Super Cereal- Corn Soya Blend with Sugar Analytical testing for CSB nutrition product should be performed against the following specifications: Main composition - Nutritional composition per 100 g 1 Moisture 10.0 % (maximum) ISO 712-2009 2 Protein 14.0 % (N x 6.25)

(minimum) AOAC 981.10 ISO 20483:2006

3 Fat 6.0 % (minimum) AOAC 954.02 ISO 11085:2008 4 Crude fibre 3.8 % (maximum) AOAC 962.09 5 Ash 4.1 (maximum) ISO 2171:2007 Chemico-physical characteristics of flour 6 Peroxide value 10.0 meq/kg fat

(maximum) AOAC 965.33

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7 Urease index 0.20 pH units (maximum)

AOCS Ba 9-58 (1997)

8 Particle size - 95% must pass through a 600 microns sieve - 100% must pass through a 1,000 microns sieve

9 Organoleptic (smell, taste, color) Pleasant smell and palatable taste, typical color 10 Consistency (Bostwick flow rate) Min 55 mm/30s for

15% dry matter porridge

WFP’s SOP http://foodqualityandsafety.wfp.org

Vitamins 11 Vitamin A 2770-4160 IU AOAC 992.04 AACC 86-03 Minerals 12 Iron 9.6-14.4 mg AOAC 944.02 AACC 40-41B 13 Calcium 350-520 mg AOAC 984.27 14 Potassium 610-910 mg AOAC 984.27 Mycotoxins 15 Aflatoxin (total) 20 ppb (total of B1, B2,

G1, G2) (maximum) AACC 45-16

Microorganisms 16 Mesophyllic aerobic bacteria 100,000 cfu per g

(maximum) ICC No 125 AACC 42-11

17 Coliforms 100 cfu per g (maximum)

AOAC 2005.03

18 Salmonella 0 cfu per 25g AACC 42-25B 19 Escherichia Coli <10 cfu per g AOAC 991.14 20 Staphylococcus aureus <10 cfu per g AACC 42-30B 21 Bacillus cereus 50 cfu per g

(maximum) AOAC 980.31

22 Yeasts and moulds 1,000 cfu per g (maximum)

ICC No 146 AACC 42-50

23 GMO (only if required) Negative (< 0.9% of GMO material) E-SUPER CEREAL plus- Wheat Soya Blend Analytical testing for WSB nutrition product should be performed against the following specifications:

Main composition - Nutritional composition per 100 g 1 Moisture 7.0 % (maximum) ISO 712-2009 2 Protein 16.0 % (N x 6.25)

(minimum) AOAC 981.10 ISO 20483:2006

3 Fat 9.0 % (minimum) AOAC 954.02 ISO 11085:2008

4 Crude fibre 2.9 % (maximum) AOAC 962.09 5 Ash 5.0 % (maximum) ISO 2171:2007 Chemico-phisical characteristics of flour 6 Peroxide value 10 meq/kg fat (maximum) AOAC 965.33 7 Urease index 0.20 pH units (maximum) AOCS Ba 9-58 (1997) 8 Particle size - 95% must pass through a 600 microns sieve - 100%

must pass through a 1,000 microns sieve

9 Organoleptic (smell, taste, color) Pleasant smell and palatable taste, typical color

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10 Consistency (Bostwick flow rate) min 100 mm/30s for 17% dry matter porridge

WFP’s SOP http://foodqualityandsafety.wfp.org

Vitamins 11 Vitamin A 2780-4170 IU per 100g AOAC 992.04 AACC 86-03 Minerals 12 Iron 9.9-14.8 mg per 100g AOAC 944.02 AACC 40-41B 13 Calcium 440-660 mg per 100g AOAC 984.27 14 Potassium 700-1050 mg per 100g AOAC 984.27 Mycotoxins 15 Aflatoxin (total) 5 ppb (B1, B2, G1, G2)

(maximum) AACC 45-16

Melamine 16 Melamine 1 mg/kg maximum Microorganisms 17 Mesophyllic aerobic bacteria 10,000 cfu per g

(maximum) ICC No 125 AACC 42-11

18 Coliforms 10 cfu per g (maximum) AOAC 2005.03 19 Salmonella 0 cfu per 25g AACC 42-25B 20 Escherichia Coli 0 cfu per g AOAC 991.14 21 Staphylococcus aureus 0 cfu per g AACC 42-30B 22 Bacillus cereus 50 cfu per g (maximum) AOAC 980.31 23 Yeasts and moulds 100 cfu per g (maximum) ICC No 146 AACC 42-50 24 GMO (Only if required) Negative (< 0.9% of GMO material)

4. Deliverables

Chemical and microbiological test results on pharmaceuticals should be provided within two weeks of sample receipt. In case of individual specification testing, results should be provided within one week of sample receipt. Sterility test results for pharmaceuticals should be provided within 3 weeks of sample receipt. Insecticide content results and mechanical test results for bednets should be provided within one week of sample receipt Results on nutritional composition (e.g. protein, lipids, vitamins, minerals) should be provided within two weeks of sample receipt. In case of individual specification testing, results should be provided within one week of sample receipt. Microbiological test results on nutrition products should be provided within one week of sample receipt. Tests for Chronobacter spp., will be carried out when the EB results are higher than the specification allows and test results should be provided within one week. Test results on Aflatoxins should be provided within one week of sample receipt.

5. Reporting requirements

Test results should be provided in English in the form of a report where at least the following information should be included: Header Section: Name, address and contact details of the laboratory conducting the analysis General Information Section: Name of product, dosage form, name of manufacturer, lot/ batch number, manufacturing date, expiry date, purchase order (if applicable)

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Analysis Section: The test name, the result, the acceptance criteria or specifications, and a reference to the test method used should be included for each characteristic listed. Actual data and observations should be recorded rather than non-specific “passes” or “conforms” statements. Footer section: Identity and signature of authorized individual for approval, date of approval, page number (i.e 1of 3)

The report should be sent electronically in PDF format to UNICEF SD Quality Assurance Centre and to the UNICEF Country in case they have requested the analysis. A hard copy of the report accompanied by the invoice should be send to UNICEF country office or to UNICEF SD Quality Assurance Centre. In case of “out of specification results” the subject line of the Email and the report should state “Alert OOS results”

6. Duration

It is expected that 24 month Long Term Arrangement(s) with possible extension for further 12 months will be put in place in January 2018

7. Response from Bidders:

The Technical Proposal should include but not limited to the following: - Detailed Methodology/Approach to project, demonstrating how you meet or exceed UNICEF

requirements for this assignment.

- An overview of the Quality system in place should be provided including details on:

- Receipt of Samples

- Processing of Samples

- Storage of Samples

- Disposal of Samples

- ISO or WHO certification as detailed in section 8 (Qualification requirements)

- Expertise of Company detailing the general and specific experience similar assignments in the past

five years. More specifically evidence of similar assignment implemented in the past Evidence

could be in form of job completion certificate, contracts and or references. The submission should

also include list of five similar assignment in terms of requirements and scope implemented in the

past 5 years. Please provide the following:

- Name of Client

- Title of the Project

- Scope of the Project/Requirements

- Proposed Solution/Outcome

- Project timelines (start and end date year, etc., and any other information necessary)

- Reference /Contact person with the reference

- Detailed resume of the person responsible for the laboratory and the person in charge of the

project, if different

- Number of personnel to be involved in the project and educational qualifications/ professional

experiences

8. Qualification requirements

Laboratories conducting tests on pharmaceuticals and bednets should be WHO pre-qualified

They should also operate according to WHO Technical Report Series No. 957, 2010 – Annex 1 “Good practices for pharmaceutical quality control laboratories”.

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Laboratories performing tests on nutrition products must be ISO 17025 certified and accredited to perform testing for Salmonella (ISO 6579), Enterobacteriaceae (ISO 6579) and Chronobacter spp (ISO 22964)

Laboratories should have a proven record of working with UN organizations or international organization such as e.g. WHO, WFP or the Global Fund.

9. Evaluation Process and Methods

Proposals meeting the mandatory criteria specified above and in Annex II will continue into the evaluation of the technical proposals on the basis of the following technical criteria per lot.

s/no Technical Evaluation Criteria Points

Technical Approach

1 Proposals will be assessed on the extent to which the proposed approach and methodology are solid, feasible, implementable, and effective and demonstrate a clear understanding of the nature of the work being undertaken and the environment in which the work must be performed. The proposed work plan must also describe that there will be no issue with custom clearance of samples submitted. The lead time for analysis must be specified in the proposal and meet the above stated deadlines. The laboratory must also demonstrate that they have a sufficient capacity to deal with the anticipated number of analysis in a timely way. ISO and WHO Certification. Quality Assurance and risk mitigation put in place.

40 points

2 Expertise of the Personnel and Organization - Proposals will assess the extent to which the laboratory has sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions.

10 points

A The Head of the Laboratory (supervisor) must be of a high professional standing with extensive experience in drug analysis and laboratory management in a pharmaceutical control laboratory in the regulatory sector or in the industry.

B The analysts, who must be graduates in pharmacy, analytical chemistry, microbiology or other relevant subjects with the requisite knowledge, skills and ability to adequately perform the tasks assigned to them by management and to supervise technical staff. Personnel should have the minimum qualification and experience as mentioned.

3 Organizational Capabilities and Past Performance 20 points

Organizational Capabilities and Past Performance Proposals will be assessed based on the extent to which the Proposer’s corporate and institutional capability demonstrates an ability to successfully and quickly launch and implement the Terms of Reference.

Overall total points for technical evaluation 70 points

Only Submissions that scores 50 points and above shall be considered further

Commercial Evaluation: The overall total for each lot shall be used for the commercial evaluation of all technically compliant bidders. The commercial evaluation shall be done as shown below: The price should be broken down for each component of the proposed work, based on an estimate of time taken which needs to be stated (see Annex III). The total amount of points allocated for the price

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component is 30. The maximum number of points will be allotted to the lowest price proposal per lot that is opened and compared among those invited firms/institutions which obtain the threshold points in the evaluation of the technical component. All other price proposals will receive points in inverse proportion to the lowest price; e.g.: Max. Score for price proposal * Price of lowest priced proposal Score for price proposal X = ------------------------------------------------------------

Price of proposal X On completion of the technical and commercial evaluations, the two scores as per the 70/30 criteria for each lot will be combined and award(s) will be made per lot.

10. Administrative issues – Payment Schedule

Laboratories are requested to provide price quotes for individual parameter testing as well as for comprehensive testing.

Payments will be issued 30 days after receipt of the invoice and satisfactory validation of the test report.

Invoices are to be sent to the office that requests the analysis. It will either be UNICEF Supply Division or a UNICEF Country Office

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Appendix I: Test Turnaround Time Compliance table

s/no Type of Test Turnaround

time for result Compliance (YES/NO)

Comments

Chemical and microbiological test results on pharmaceuticals

2 weeks

Individual specification testing for Chemical and microbiological test results on pharmaceuticals

1 week

Sterility test results for pharmaceuticals and medical devices

3 weeks

Insecticide content results and mechanical test results for bednets

1 week

Nutritional composition (e.g. protein, lipids, vitamins, minerals)

2 weeks

Individual specification testing 1 week Microbiological test results on

nutrition products 1 week

Tests for C. sakazakii, will be carried out when the EB results are higher than the specification allows

1 week

Aflatoxins 1 week Notification of OOS results Depending on

the turnaround time for the above mentioned tests

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Appendix II – Laboratory Qualification

s/no Laboratory Mandatory Qualification Compliance (YES/NO)

Comments

1 Is your Laboratory WHO Prequalified to conduct tests on pharmaceuticals according to WHO Technical Report Series No. 957, 2010 – Annex 1 “Good practices for pharmaceutical quality control laboratories”

Please provide document evidence

2 Is your Laboratory ISO 17025 certified and accredited to perform testing for Salmonella (ISO 6579), Enterobacteriaceae (ISO 6579) and C. Sakazakii (ISO 22964)?

Please provide document evidence

3 Does your laboratory have proven experience working with UN organizations or international organization such as e.g. WHO, WFP or the Global Fund?

Please provide document evidence. Evidence could be past contract or completion certificates e.t.c.

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Appendix III – Technical Evaluation Criteria

Lot I – Pharmaceutical - Bednets s/no Technical Evaluation Criteria Points

Technical Approach

1 Proposals will be assessed on the extent to which the proposed approach and methodology are solid, feasible, implementable, and effective and demonstrate a clear understanding of the nature of the work being undertaken and the environment in which the work must be performed. The proposed work plan must also describe that there will be no issue with custom clearance of samples submitted. The lead time for analysis must be specified in the proposal and meet the above stated deadlines. The laboratory must also demonstrate that they have a sufficient capacity to deal with the anticipated number of analysis in a timely way. ISO and WHO Certification. Quality Assurance and risk mitigation put in place.

40 points


10 points






Only Submissions that scores 50 points and above hall be considered further

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Lot 2 – Therapeutic Foods s/no Technical Evaluation Criteria Points

Technical Approach

1 Proposals will be assessed on the extent to which the proposed approach and methodology are solid, feasible, implementable, and effective and demonstrate a clear understanding of the nature of the work being undertaken and the environment in which the work must be performed. The proposed work plan must also describe that there will be no issue with custom clearance of samples submitted. The lead time for analysis must be specified in the proposal and meet the above stated deadlines. The laboratory must also demonstrate that they have a sufficient capacity to deal with the anticipated number of analysis in a timely way. ISO Certification. Quality Assurance and risk mitigation put in place.

40 points


10 points






Only Submissions that scores 50 points and above hall be considered further

Appendix IV - Financial Proposal Form (refer to attached spread sheet)

Documents

Annex B - Terms of Reference for Laboratory Services 1.€¦ · A pharmaceutical product is generally tested either against its compendial specifications [i.e. The International Pharmacopoeia