RFP TGF-014- Round 1 Questions and Responses No Question Response

Transcription

RFP TGF-014- Round 1 Questions and Responses No Question Response
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
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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.
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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
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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.
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performed in the RFP’, Could you clarify to which
additional task this refers?
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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?
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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.
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pharmaceuticals only or generally. [cfr. B1 line 8 general
experience to be detailed in B3)
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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.
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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.
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Schedule F Communications management: kindly confirm
that this optional service could be offered by the
Consignment Inspection and sampling agency;
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Is there any possibility to have the deadline for submission
extended?
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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
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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
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Yes the bidder is required to test all the products per category.
Please also see s.no 1 of this document.
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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
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