RFP TGF-014- Round 1 Questions and Responses No 1 Question Response Do I understand correctly that we can bid either for ARVs, Anti-TB or Anti-Malarial? Would it be preferred that a lab covers all products? That is correct. A Quality Control Laboratory (QCL) can quote any one of the three but completely for all the products for that part. For example, if the QCL chooses to quote only for ARV, then the QCL should quote for all the ARV products in Schedule B2. Of course for obvious reasons if a QCL is able to test all products in all three categories of drugs, it will be preferred. 2 Is it expected, that the distribution between these three types of products, as provided under item 3, table 4, will be comparable in the following years (i.e. with very low number of batches of ARVs)? It is not predictable. This is a general trend, linked to the randomization process applied (refer Tab 2, par 2.5)We find in our experience that the number of ARVs referred to the labs are decreasing due to the reason that more and more ARV products are getting prequalified by WHO or approved by SRA. For ARVs, only the ERP reviewed category is tested. For TB and Malaria, the randomization process is different than for ARVs. WHO prequalified or SRA products are also tested at different rates, depending on the program 3 4 Do I understand correctly that a QC lab applying for the testing has mandatorily to cover item 2.2.3 of the RFP (review of certificates including CoA Database development), but is free to also apply for item 2.2.4 (communications management)? Yes that is correct. We require that item 2.2.3 be performed by the lab that will undertake QC testing. For 2.2.4, it is not mandatory that the QC lab respond to this. Is it mandatory to test for dissolution of oral dosage form? Especially in case pharmacopoeia does not test for Page 1 of 12 5 dissolution but in-house methods still test for dissolution. In this case do the Lab need to do method transfer of dissolution with manufacturer then test for dissolution in routine test following in-house method? Yes you are right, the dissolution test is requested and if not included in pharmacopoeia methods, the lab will need to perform this test as per the manufacturer specification and ensure method transfer for this parameter. We understand that the evaluation will be in two stage: technical evaluation and cost evaluation. Do we need to submit Cost Proposal at the same time with Technical Proposal? Do we need to submit them in separate emails? Yes that is correct. The response to the RFP should be complete with all schedules completed and submitted by the dead line. Cost Proposal and Technical Proposal must be submitted simultaneously and in separate emails by 14 November 2014 17.00hrs 6 We learn from the RFP that the Cost proposal will not include the cost for Reference Substances (RS). Could you let us know who will provide RS? Because we understand that our capability to test the listed products does not mean that we have to establish or purchase those RS by ourselves. Do we understand right? Yes that is correct. In practise so far we have been able to obtain the RS manufacturers for almost all the products, for assay or for testing related impurities. However in exceptional cases where RS is required for any specific need, the Global Fund would pay for it separately when such a situation would arise. Any related expense towards the procurement of a RS will be met by the Global Fund, based on pre-approval by the Global Fund, that the lab procured the said reference substance. 7 In B3 form, it is requested that the bidder need to "Provide copies of all SoP related to different activities performed in the QC Laboratory". Are they Subcontracted Lab's SoPs or both Subcontracted Lab's SoPs and SoP of ourselves? Do we need to provide every SoP in detail or just the list of SoP? The QCL is requested to provide the list of its SOPs (and the SOPs list of the sub contracted lab if the QCL subcontracts some testing to another laboratory) as well as the detailed SOP related to Handling Out of Specification. 8 Is there any reason to explain why in 6.2, it is stated: «The quote offered for testing should include the cost of all materials used in testing EXCEPT the cost of reference See question. No 6 of this document. Page 2 of 12 standards. The offeror shall quote the cost for testing without taking into account the cost of reference standard»? Will the standards be provided to the Quality Control Laboratory? 9 In order to be able to give adequate quotation, specifically for method transfer or method validation, we will need to get the Manufacturer’ specification or Manufacturer’s Method mentioned on the list attached to this email It is not practically possible to provide the manufacturer’s method for each product especially in most cases there are multiple manufacturers. So we have clearly stated in page 15 (6.2) that for such non-compendial products the bidder shall quote for the specified tests (a to i) for both Method transfer and for routine testing of the non compendial product Please refer to 6.2 (second bullet point) For non-compendial products (i.e., products that do not have monograph in any of the above three pharmacopoeias), these should be tested as per manufacturer’s in-house specification. Since the in-house specifications are not available, the bidder shall consider for quoting the cost for testing for routine testing as well for method transfer based on (a) Identification based on API specifications (b) Related subs based on API Specification (c) Dissolution test (d) Disintegration test where applicable (e) Uniformity of content where applicable (f) Assay based on API specification (g) Sterility test where applicable (h) Endotoxin test where applicable and (i) Microbial count where applicable. However in practise after the conclusion of the contract, when there are more tests to be performed as per the manufacture’s specification, the cost of that particular product can be revised as per the mutual agreement. 10 Will the "Global Fund" provide to the Bidders the Word version of the following documents: A2 (page 29-30), Schedule B (page 31) and later Schedule C and Schedule D? Document A2: No Word version: have to be printed, manually completed and signed Schedule B: No Word version: have to be completed directly on the Excel sheet Document C: We will post a word sheet to complete the November, 26th as indicated on the RFP Page 3 of 12 Document D: No Word version: have to be printed, manually completed and signed. 11 Is it possible for a Laboratory qualified by the NRA (National Regulatory Authority) or the SRA (Stringent Regulatory Authority, can be used for microbiological testing instead of WHO pre-qualified or ISO 17025 qualified Laboratory? When the Quality Control laboratory subcontracts tests, it is to be done in a laboratory that fulfils the required eligible criteria mentioned under 1.4.3” , then the sub-contracted lab can only be WHO prequalified WHO prequalified lab as a rule and in exceptional case, upon mutual agreement, sub contracted lab can be ISO 17025 certified. 12 With regards to the (RFP) TGF-14-052 tender document, with reference to Section 6.2. Are local clearing charges for reference standards catered for or should be included in the quote? See answer No 6 of this document. Could we include additional text in our Proposal, in addition to the standardized excel tables/schedules? Yes. Please do not alter the format of the existing sheets. Where space is provided (Schedule B1 and B3), additional info relevant to the Schedule can be included. If needed, the bidder can attach a separate sheet/s as well. 14 Further to paragraph 2.1.4. of the RFP, where an example is given of the inspection activities for AMFm/Private Sector Co-payment Mechanism, would the packing/labelling requirements to be taken into account for Global Fund and GDF also be uniform for all their products, or different per product or per product/manufacturer? The example given is not only for AMFm project, the same requirements will be applied for any type of PSI. Packing/ labelling requirements are also common for all type of products. A SoP will be developed at the time of concluding the contract between the bidder and the organisation (GF, GDF) according to the needs of the organisation. 15 Ref. Schedule B3 for QC Laboratory, work sheet ‘Past Performance’ last point: ‘Please explain how your laboratory will manage the additional task required to be The activities in the RFP are by itself an added work to your laboratory’s existing activities. So we need to know how your lab plans to manage the work stated in the RFP, including and respecting the time schedules given in the Schedules. 13 Page 4 of 12 performed in the RFP’, Could you clarify to which additional task this refers? 16 17 18 RFP point 7.3.3 – confidentiality agreement: at which stage this confidentiality agreement shall be submitted to you and then received signed? Would it be possible to submit it and receive the countersigned copy before tender closure? Yes, it’s be possible. As soon as the confidentiality agreement is completed and signed, you can submitted it to us RFP point 7.4.4 – submission of proposal: our understanding is that the maximum size limit for each single email is eight (8) MB. Kindly confirm No, this is the maximum size limit for each single file. In any case the bidder after sending the document should wait for the acknowledgement from our side. RFP point 7.4.7 – submission of proposal: kindly clarify if you expect to receive the technical proposal and the cost proposal through separate e-mails explicitly stating “technical proposal” and “cost proposal” or else. e.g. Option one would be more appropriate Option one: 1st e-mail: Inspection Agency’s name Technical Proposal No. XXX – RFP TGF-14-052 1 of 4 2nd e-mail: Inspection Agency’s name Cost Proposal No. XXX – RFP TGF-14-052 1 of 1 Option two: Inspection Agency’s name, Proposal No. XXX – RFP TGF14-052 1 of 4 Page 5 of 12 19 RFP point 7.4.4 – submission of proposal: a duplicate copy of all documents, either in Microsoft Word, Excel or Power Point format is requested. Kindly confirm you refer to the duplicate of Schedule B1 and B3 forms only or else. We actually refer to all stage 1 documents you will submit : Schedule B1 Schedule B2 Schedule B3 Additional documents if applicable You also send a signed copy of all submissions in PDF format. RFP point 7.4.2 – in case the same company/legal entity offers both of the services could there be the case that you could award for just one service according to evaluation score obtained for each considered separately? One bidder can apply for all the three or any one or two. 21 RFP point 7.4.1 – in case the same company offers both inspection and sampling services and communications management (or testing services and communications management), kindly confirm whether you would evaluate and could award them separately (one or the other or both) See point 20 of this document. 22 RFP point 7.4.1 – kindly confirm whether you expect the templates Schedule B1 and Schedule B3 to be filled in as they are presented or if they are to be considered as a guideline for putting the technical proposal in writing; The templates Schedules B1 and Schedule B3 should be filled in as they are presented. You are free to write additional details in the space provided in the Schedule B1 and B3 or on a separate sheet/s, attached to the applicable Schedule. 20 The adjudication will be separate for (i) consignment inspection, sampling (ii) QC testing and CoA review (iii) communication management. So a company submitting an application for both inspection/sampling and testing services can be awarded for one or the other or both or neither; either with or without the communications management activity. Page 6 of 12 23 RFP point 7.4.1 Schedule B1 – in the case the same company offers different tests from different laboratories – of which one is WHO pre-qualified but the others are also working under GMP/GLP and regularly inspected by international authorities like MHRA and FDA - would this be regarded as acceptable? When the Quality Control laboratory subcontracts tests, it is to be done in a laboratory that fulfils the required eligible criteria mentioned under 1.4.3” , then the sub-contracted lab can only be WHO prequalified WHO prequalified lab as a rule and in exceptional case, upon mutual agreement, sub contracted lab can be ISO 17025 accredited. 24 RFP point 1.4.2 and 7.4.1 Schedule B1 – the Consignment Inspection and Sampling agency should be able to respond to the required task in all the countries mentioned in schedule B2. Does this mean that an agency that does not have such full coverage and adheres to the OFAC policy (no operations for and in the embargoed countries) would not qualify? Preference will be given to an agency that is capable of performing the required task in all the countries. . If there is the Global Fund-funded grant implemented in such a country as mentioned, or a manufacturer is offering the product from such a country, there should be a way to do the required task in that country. 25 RFP point 1.4.1 and 7.4.1 Schedule B1 – turnaround time for completing consignment inspection and sampling is indicated in five (5) working days including time taken to dispatch samples to the specified quality control laboratory. Kindly note that time taken to dispatch samples to the specified laboratory depends on a no. of factors independent from the inspection and sampling agency, such as actual location of inspection (e.g. remote location vs. main capital city), destination of the samples (laboratory location), courier, logistics within involved countries. Would you consider a turnaround time that wouldn’t include the time taken to dispatch samples to the laboratory? This is a general requirement and in our experience, the Turn Around Time given is reasonable from the time of arrival of the inspector in the country. In most cases the consignments are available in main ware houses in the capital city. However on case by case basis things can be relaxed at the required situation. For answering the RFP the bidder shall consider the routine situation for the work required. Moreover the time taken to dispatch the sample refers only to the booking of the sample in the country with the courier service and not to the receipt of the sample at the designated lab. Page 7 of 12 26 27 28 29 30 RFP point 7.4.1 Schedule B2 – cost table for consignment inspection and sample forwarding: here a sample The cost of courier depends on the volume of the samples to be shipped. The forwarding courier cost is to be given. Kindly note that bidder can consider the cost of courier for minimum permissible volume to be courier costs depends on a number of factors such as, shipped to the designated country. sample size/dimension/volume and weight, country of departure and arrival, etc. Such information cannot be predetermined at this stage. Would you consider an ex-post cost-based approach upon presentation of relevant courier receipts? RFP point 2.1 sample handling – it is our understanding that the Consignment Inspection and Sampling agency shall segregate relevant samples and prepare the parcel for dispatch to the designated laboratory and leave it to the supplier for courier pick. Kindly confirm that this is a suitable approach in your view. RFP point 2.1 sample handling – which will be the frequency per month of sampling batches to be tested? RFP point 2.6 and Schedule B2 Cost table-QC testing: it is our understanding that the reference material standard will be provided to the laboratory by the Global Fund, kindly confirm. RFP point 2.6 and Schedule B2 Cost table-QC testing, method validation development and transfer. It is our The good practice is that the the Consignment Inspection and Sampling agency, after having segregated the relevant samples , prepares the parcel for dispatch to the designated laboratory, books the samples with the courier and does not leave it to the manufacturer/supplier to do it . The frequency cannot be predicted as it depends of the procurement made by the countries In the RFP Page 13, table 3, the number of PSI performed in 2012, 2013 and 2014 are given , showing an average of 60 PSI/ Sampling per months See point 6 of this document See point 9 of this document Page 8 of 12 understanding that the manufacturer method will be shared with us and will be provided by Global Fund, kindly confirm. If methods are not available, do we have to develop and validate new method, i.e. where can we provide the separate costs for that (not in the method transfer tab). Regarding method transfer, will the manufacturer QC lab be available for a lab-to-lab method transfer? If not do we need to validate the method? And have the method be done according to ICH guidelines? 31 32 33 FP point 6.4 Communications management – note: the Global Fund not pay for any costs related to the destruction of samples and retaining of samples for the prescribed period of time. Kindly confirm whether this is actually applicable to the communications management or it was included by mistake. RFP Schedule B3 General Information: kindly clarify what is meant by “name of organization accredited by or name of the inspection agency enrolled in. Attach relevant certificate” RFP Schedule B3 Past performance: “client or source of Funding with organizations worked with during past 3 year’s period” and “client reference (name, position, etc…)”.Kindly confirm whether here we shall refer to At the request of the QCL who is making the method transfer, the manufacturer will be asked to provide all the necessary information to properly implement the method and exchanges with manufacturer laboratory could be envisaged. The contracting QC lab is not requested to revalidate the method, but to implement the method based on data and validation provided by the manufacturer and according to ICH guidelines principles. We confirm that the note is not well placed in the document. The note is not related to point 6.4 (Communications management with Private Sector Copayment Mechanism Suppliers) but to point 6.2 (For Quality control Testing) to the quality control laboratory that receives the samples for testing and the left over after testing. This should read: The Global Fund will not pay for any costs related to the destruction of samples and retaining of samples for the prescribed period of time. As an example ISO17025 is the accreditation offered by certain organisation like CNAS, ILAC, NABL for QC laboratories. Likewise has the consignment inspection and sampling agency got accreditation from any internationally known organisation? OR enrolled in any internationally known inspection agency like IFIA (International Federation of Inspection Agency) So please provide the name of the organisation who certified or accredited your company as well as the relevant certificate of the accreditation In this section we expect receiving your past experience with International Organisations, as a company responsible for handling Pharmaceuticals activities like PSI/, Sampling / QC testing/Communication management. Page 9 of 12 pharmaceuticals only or generally. [cfr. B1 line 8 general experience to be detailed in B3) 34 35 RFP Schedule B3 Past performance: being the laboratory a newly WHO pre-qualified lab and therefore having relative short experience with UN agencies but having worked extensively for key counterfeit project, would this allow the laboratory to still qualify for RFP? 3 years’ experience in working with international agencies stated in the RFP is mandatory However new WHO prequalified laboratory may already have past experience at International level, not only with UN agencies, but working with international programs, NGOs, laboratory network; it is not required to have three years’ experience as WHO Prequalified laboratory. Schedule B2 cost table for Communications management: kindly confirm that cost for pertinent testing is excluded from cost for handling one purchase order Yes. This does not include the cost of testing. This is mentioned in Italics in the cost table for co-payment communication. 36 Schedule F Communications management: reference to items in red is made in order to understand the responsibility of the “communications management”, unless no red items is highlighted. Kindly clarify. 37 Schedule F Communications management: kindly confirm that this optional service could be offered by the Consignment Inspection and sampling agency; 38 Is there any possibility to have the deadline for submission extended? 39 In Schedule B1 it indicates that the bidder should be WHO prequalified. Our company is not yet WHO prequalified, We confirm that the text in Schedule F should read: Those items in italics below would be the responsibility for the “communications management” activity described in the RFP. Yes that is correct. No. We regret that this will not be possible Page 10 of 12 but is ISO 17025 accredited and also on the list Global Fund recognized testing laboratory. We are actually working on WHO PQ and I think plan is to be prequalified by next May. Will this be a problem? The mandatory requirement is that the lab should be listed in the list of WHO prequalified lab at the time of submission of the RFP. ISO17025 certification is not considered for this RFP which means that a laboratory only ISO 17025 certified is not eligible for this RFP. 40 At the top of page 5 it indicates at least 3 years of working Minimum 3 years of working experience with International organisations is experience with international organizations – Our required and mandatory to submit a proposal in response to this RFP company has not been up and running for 3 years. Will this be a problem? 41 In 6.2 it indicates that the cost of testing should not factor in the cost of reference standards. Does this mean they will be provided or that we are expected to absorb the cost of RS? See s.no 6 of this document In 6.2 it discusses what happens for non-compendial products. Will the manufacturer’s in-house method be provided or are we obligated to contact the manufacturer and obtain the method? Refer to S.no 9 of this document. When non compendial method is available the contracting QC laboratory will contact the manufacturer to receive method description, specifications and validation data to implement the new method in their QC. Will there be one for than one testing lab selected? If an offeror is awarded the opportunity, will the offeror be obligated to test all the samples that need to undergo testing? At this stage, we don’t have any particular number agreed. Regarding the eligible criteria and conditions for RFP Participation, since we are working with WHO from 2013 The first requirement is that your lab is in the current list of WHO Prequalified lab and if it is the case you fulfill one of the mandatory criteria. In addition a 42 43 44 Yes the bidder is required to test all the products per category. Please also see s.no 1 of this document. Page 11 of 12 45 we would like to know if it is possible to participate as a bidder to Quality Control analysis second mandatory criteria is that your laboratory has 3 years’ experience with any international organization as stated in the RFP Since our goal is the Quality Control analysis which one of the schedules and sheets are mandatory? For QC lab all sheets related to quality control laboratory are required to be filled in. Schedule B1-Technical Criteria Schedule B3-Request for information( General information and past performance) Schedule B2-Cost table for testing Schedule B2- Cost table for Certificate of Analysis review Page 12 of 12
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