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08/01/2024

SPECICIFICATIONS
IN PROCUREMENT
Tenders: Technical Specifications Schedule

By
Dan Kibuule
Dept. Pharmacology & Therapeutics
Faculty of Health Sciences
Busitema University, Mbale Uganda

CATEGORIES OF PARASITES
Classes of BIOMATERIALS

METALS POLYMERS CERAMICS COMPOSITE

Natural
• Carbon-carbon
• Ti & its alloys • Nylon • Aluminum Oxide
• Wire
• Silicon • Calcium Phosphates
• Co-Cr alloys • Fiber reinforced Bone Cement
Synthetic • Hydroxyapatite carbon
• Stainless steels • Rubber
BIODEGRADABLE
• Polyester
• PTFE

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Learning OUTCOMES

By the end of this session, you should be able to;


• (1) Define the term specifications
• (2) Describe the types of product specifications
• (3) Apply specifications in procurement

Procurement in a nutshell

Need is identified and the purchase is Bids are invited, clarified and
planned Bids are evaluated
closed

The User Department Develops the Bidding documents are prepared The successful bidder is selected with
Specifications as per specifications supplied in-put from the user department

If the total value of the request is


User Department completes the The buyer selects the Procurement <UGx a request must be loaded on
Individual procurement plan ( Goods, Method to Utilize in line with the the system for verification and
services and more) procurement Act approval. The Purchase order is then
issued

Once approval is obtained from the


Fully Approved Procurement Request If the total value of the request is >
Confirm budget availability through the Accounting Officer a request is loaded
Form is sent to the procurement UGx a Note to Procurement
Budget Control Process for verification and approval after which
department Committee has to be prepared
the Purchase Order is issued

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Tender cycle & Suppliers

The tender cycle depends on the capacity of the procurement agency to:

1. Select the supplies for tender


2. Quantify product requirements
3. Prequalify suppliers
4. Prepare tender documents
5. Evaluate tenders

SPECIFICATIONS in procurement

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Tender invitation
• An important document which lays down the technical and basic legal
requirements for obtaining products of acceptable quality.
• It serves as a REFERENCE in the event that problems with suppliers should arise
• It lays down the terms and conditions of the procurement.
• The document specifies, among others:

1. How the quotations should be submitted 5. Product specifications


2. Terms of payment 6. Labelling
3. Delivery periods 7. Packaging
4. Delivery schedule 8. Shelf life (> 80% on delivery)

SPECIFICATIONS in procurement

• “Specification” is the description of an object of procurement


in accordance with national and international standards
adopted and approved by the Authority after consultation
with the National Bureau of Standards or other appropriate
trade associations and professions , which shall be
mandatory in all bidding documents;

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Types: generic vs specific specifications

• The specifications are to be as generic as possible to encourage adequate


responses from potential suppliers.
• The greater the number of respondents, the greater the prospect of competitive bids.
• It is particularly important to avoid the use of brand names in material specifications.
• Where unavoidable, the phrase “or equivalent” should be used.
• A performance (or generic) specification gives a clear idea of the function,
application, and performance required of the supplied goods or services.
• From such specifications, suppliers can often provide new improved or cheaper solutions.
• Conformance (or specific) specification restricts the Supplier to providing the
actual article specifically identified.

Ideal Product specifications


• 1) Specifications are to address functions and performance
• in order to avoid elements that restrict competition such as brand, trade names, origin,
patent, design or type and producer or service provider except where such items are
must-fit or are covered by requirements under warranty term.
• 2) Specification must be clearly, accurately and completely drawn
• so as to leave no doubt in the supplier’s mind as to what the purchaser requires.
• Unnecessarily restrictive requirements, which may unduly limit the number of bidders,
shall be avoided.
• 3) The PU develops a database of material specifications
• which shall be regularly maintained and updated to ensure its accuracy and reliability.
• A database is an invaluable management tool for facilitating the objectives of the supply
process under the sector i.e. efficiency, economy, and transparency without sacrificing
quality

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Use of brand names and patents

• We do not encourage specification by brand names or patents.


• However, due to prevalence of identification and prescription of specific
materials for particular ailments by medical practitioners, such special
references may be used when procuring the drugs from potential
suppliers provided the words “and/or” equivalent are used in order to
avoid restriction of competition.

Samples
• 1) For each product item where necessary, inter alia because of high risks
and quality assurance reasons, require product samples.
• The bidding documents should identify this requirement by requiring the bidder to
provide samples for evaluation with the bid submission or before award, allowing a
reasonable time for such submission.
• 2) Procedures and details of tests to be conducted should be specified
• Results of tests obtained within a reasonable time of about two weeks.
• bidders required to submit, along with their bids, test results conducted in a
recognized laboratory.
• 3) If the samples fail, pursuant to tests conducted,
• bidders will be notified of the discrepancies and items of failure accompanied with
test reports submitted by the bidder

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Demonstration samples
• When it is difficult to specify consumables such as disinfectants and
laboratory chemicals adequately and clearly, potential suppliers may be
asked to demonstrate performance of a product. Otherwise the samples
should be accompanied by a certificate of conformance to specifications
from an authorized laboratory.
• Items like hospital disinfectants may be subjected to testing by bidders
demonstrate effectiveness or appropriate method of use at the
procuring entity’s premises.
• Once a sample has been approved, all the supplied products must
conform to the sample

Specifying testing and inspections

• 1) In addition to specifying performance of equipment or products for


the health sector, the Tender Document shall when appropriate specify
testing and inspection requirements in order to derive confidence in the
delivered item by applying the following testing and inspection options:
• a) In-process testing and inspection at the manufacturing stage including
assessment of quality assurance documentation in place at the end of
production or pre-shipment inspection (PSI)
• b) Acceptance testing at the time of receipt, installation and /or commissioning;
and
• c) The party to meet the cost of testing and inspection is to be explicitly spelt out
in the tender document and the contract.

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National and International Standards


• 1) Unless existing standards may not meet user’s needs for instance due
to new technological advances or practices, the relevant national or
international standards should be used to enhance testing, inspection
and suppliers responsiveness.

Specifications: REJECTION OF BIDS

• Technical Specifications (Product)


• Manufacture: GMP standards
• Finished product: Quality / Standards
• Pharmacopeia standards (BP, USP)
• Properties: Physicochemical & biological
• Quality control tests: analytical methods
• Stability and biocompatibility
• Toxicity, efficacy
• Performance

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6 Properties of Materials
• A property: is a characteristic behaviour of a material when exposed to external STIMULI
• i.e. the kind and magnitude of response to a specific stimulus

Mechanical Magnetic Electrical

Chemical Thermal Optical

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Specifications: REJECTION OF BIDS

• The Purchaser reserves the right to reject any bid at any time during the
ongoing evaluation, which does not substantially respond and conform to all
terms, conditions and technical specifications of the Bidding Document.
• The Purchaser reserves the right to reject any Bid, which fails to present
fundamental documentation as requested in the Bidding Document and
therefore appears inadequate.
• The Purchaser reserves the right to reject any Bid from a company previously
failed to perform properly contracts of a similar nature or did not complete on
time
• Products that do not meet the required specification will be rejected and will
be replaced by the supplier with no additional cost.

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Estimated vs Fixed tender QUANTITIES


• Fixed-quantity, scheduled delivery purchasing contract
• Fixed quantities and delivered at once or several smaller shipments over the life of the contract.
• Risk of overstocking if the quantity far exceeds actual requirements.
• Risks paying higher prices for additional orders if the quantity ordered is less than the actual need
• Estimated quantity, periodic-order contract
• The tender quantity is based on an estimate and the contract price is negotiated for each item.
• Orders are then placed periodically.
• Suppliers face the risk that the amount actually purchased may differ from the estimate.
• Split or single awards
• To avoid being dependent on one supplier, contract awards are split between 2 or 3 suppliers.
• This method enables procurement agencies to maintain links with several suppliers.
• The use of this mechanism, however, may result in higher prices

Technical Specifications to bidders

• 1. Quantities
• The required quantities of medical supplies and instructions as to how the packing
should be done in kits, will be specified in the ”Specifications and schedule of
requirements”.
• 2. Qualifications of Manufacturers
• The Bidder furnishes copies of all certificates and documents issued by the proper
National Authorities, that the Manufacturer of the products and equipment is authorised
to manufacture and sell these products.
• 3. Appraisal
• Placement of orders with a company, which is not known by the Purchaser or is not well
recognised by the international community, will require that the company provide
evidence of certification by an internationally recognised authority

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Technical Specifications to bidders


• 4. Standards And Quality Assurance For Supply
• Any medical product offered must be manufactured in conformity with the latest edition of
British, International, United States, French or European Pharmacopoeia.
• If the product is not included in the specified Compendia, the Bidder upon being awarded the order, must
provide the reference standards and testing protocols to allow for Quality Control.
• Any offered product must be manufactured in accordance with Good Manufacturing Practices
(GMP) standards established by the World Health Organization.
• All medical products must:
• meet the requirements of manufacturing legislation and regulation of pharmaceuticals and medical
products in the country of origin
• indicate the dates of manufacture and expiry.
• arrive at the port of entry (for imports) or warehouse (for local purchases) with a remaining shelf life of at
least 80% of the total stipulated shelf life at the time of manufacture.
• On request, make available samples and studies showing bioavailability and stability,
• especially stability under conditions of high temperature and humidity.
• prove the Quality of packing and the appearance of labels through representative samples on request.

Technical Specifications to bidders


• 5. Product Information
The following information will be required, when applicable, for each product
offered by the Bidder:
• generic name or INN (International Non-propriety Name)
• presentation, strength, quantity in each container
• country of origin, name and address of the Manufacturer
• Pharmacopoeia or other applicable compendia standards
• proper documentation of Quality assurance
• Shelf life
• Type of container
Failure to include any of this information may, at the discretion of the Purchaser,
disqualify the bid.

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Technical Specifications to bidders


• 6. Labelling
• The language of the labels should strictly be English.
• The label for each pharmaceutical product shall meet the W210 GMP standard and include:
• the INN or generic name prominently displayed
• the active ingredient per unit, dose, tablet or capsule, etc. (strength & presentation)
• the applicable pharmacopoeia standard
• the Purchaser’s logo and code number if required
• content per container
• instructions for use ( only on instructions by the purchaser)
• special storage requirements
• batch number
• date of manufacture and date of expiry.
• name and address of Manufacturer
• country of origin
• Keep out of reach of children”
The outer carton should also display the above information.

Technical Specifications to bidders


7. Packing
• Containers for Pharmaceuticals must conform with any of the latest of the
internationally recognised Pharmacopoeia Standards, such as British, United
States or European.
• The size of the container should be proportional to its content, with the addition
of appropriate padding to prevent damage to the product during transport.
• Containers should be tamper-proof.
• Ampoules should be one ended and autobreakable.

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Technical Specifications to bidders


• 8. Packing Of Goods
• The Vendor shall ensure that the packing of goods is according to
appropriate commercial standards and adequate to protect the goods for
carriage by sea to the agreed port of entry or address of delivery.

END

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