BACKGROUND

The Access to Medicines, Vaccines and Pharmaceuticals (MVP) Cluster has departments in the wider framework of Universal Health Coverage and the WHO 13th Global Programme of Work, and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, Non Communicable Diseases (NCD) and mental health) towards achieving the UN wide Sustainable Development Goals. The cluster therefore works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres. The MVP Cluster has two departments; The Department of Regulation of Medicines and other Health Technologies (RHT) (covering medicines, vaccines, other biologicals, blood products, medical devices and diagnostics) and the Department of Essential Medicines and Health Products (EMP).

The two departments within MVP have various teams covering the normative and standard setting work, the prequalification of medicines, vaccines and diagnostics for UN and international procurement, and the strengthening of regulatory systems and networks; as well as work on detection and prevention of substandard and falsified (SF) medical products.

The objective of the Regulatory Systems Strengthening Team (RSS) in RHT is to support all Member States to strengthen their capacity so that they will have regulatory systems to ensure that all medical products and other health technologies on their markets meet internationally recognized standards of quality, safety and efficacy. From this perspective RSS contributes to access to medical products of assured quality and to strengthening health systems in Member States. The RSS Program is therefore focused on strengthening of regulatory systems in a manner  consistent with timely access to and effective oversight of priority products of assured quality.

Purpose of the work:

carry out  laboratory analysis of samples of products in accordance with the specifications and methods as indicated by WHO in the survey testing protocol and submit certificates of analyses and detailed report of the analysis for each sample analysed within the agreed times.

Work to be performed:

The service provider will be expected to;

• Perform analysis of samples of pharmaceutical products in accordance with the specifications and methods as indicated by WHO RSS in the survey testing protocol.
• Obtain primary reference standards where required for the analyses. 
• Submit to WHO RSS a test report and detailed report of the analysis for each sample tested within the agreed times.

The specific activities include:

• Receipt of samples collected from participating countries and test them using the appropriate techniques as described in the table below.
• interpretation and evaluation of the test outcomes;
• preparation of reports in the appropriate format and provide input on the implications of the test data; and
• contribute to the NIR library development as applicable.

   

  In general the following tests will be required;

   

• Scanning each provided sample with the handheld NIR scanner to be provided by WHO RSS specifically for the survey and submitting the results to the WHO.
• Scanning each provided sample with own laboratory benchtop NIR spectrometer and submitting the spectra to WHO for further processing.
• Visual inspection  of FPP, primary package, secondary package and  information leaflet.
• Gravimetric testing: uniformity of mass, average mass of the FPP and weight of the information leaflet.
• Dimensions testing: FPP and information leaflet.
• Identification Test: HPLC, UV, FTIR, TLC and/or chemical as per protocol requirements for each product.
• Assay: HPLC, UV and/or titrimetric as per protocol requirements for each product.
• Dissolution: HPLC or UV as per protocol requirements for each product.
• Related substances: HPLC or TLC as per protocol requirements for each product.
• Uniformity of dosage units by mass variation or as applicable.

Please refer to the attached RFP documents for more details.

Planned timelines:

Start date:  01/07/2018

End date:   01/10/2018

Key requirements for this assignment:

• The service provider should have existing Near Infrared spectroscopy equipment suitable for screening of pharmaceuticals and demonstrated technical competence and experience to perform the tests required.
• Equipment to be used for the screening and comprehensive laboratory testing must already be available at the laboratory including operating procedures and trained staff.
• No subcontracting to another laboratory will be permitted unless the contract laboratory meets the accreditations stated in 3.2.1.
• Sample shipment (import) and handling processes should provide adequate sample custody integrity.
• The service provider should be able to conduct pragmatic testing of samples including cases where less than generally expected sample is provided especially for suspected falsified products

Language requirement

expert level of English.

Submission of proposals:

No later than 05 June 2018 (16:00 CET), the bidder shall complete and return by email to WHO (only when this step is completed the bidder is regarded as a prospective bidder):

a       A proposal for the overall cost to undertake this project.

c)      RFP Confidentiality Undertaking form completed/signed.

d)      RFP Acknowledgement form completed/signed as confirmation of the bidder's intention to submit a bona fide proposal and designate its representative to whom communications may be directed, including any addenda.

e)      RFP Acceptance form completed/signed.                 

f)       RFP Completeness form completed/signed.                                                                                                                                  

A prospective bidder requiring any clarification on technical, contractual or commercial matters may notify WHO via email at the following address no later than 5 days prior to the closing date for the submission of offers:

Email for submissions of forms and proposal:       kuwanaru@who.int

(use subject: Bid Ref HQ/MVP/2018/RSS/TAL-2)