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SECTION VII TECHNICAL SPECIFICATIONS

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					SECTION VII: TECHNICAL SPECIFICATIONS
           Technical Specifications




TECHNICAL SPECIFICATIONS: PHARMACEUTICALS




                   Sec.VII-2
        Section VI:           Technical Specifications
1. SPECIFICATION OF INJECT ABLE CONTRACEPTIVES:
   MEDROXYPROGESTERONE SUSPENSION 150MG/ML

         1 Actives                        150mg of medroxyprogesterone
           ingredient/generics name
           and strength
         2 Additives                      Various additives as required for the
                                          formulation of the preparation. Additives must
                                          not influence the medical effect of the drug nor
                                          be toxic in the used concentration or cause local
                                          irritations.
         3 Formulation, dosage            Each vial containing 1ml sterile aqueous
           form                           injectable suspension for intramuscular (IM)
                                          depot injection.
         4 Description                    An aseptically closed glass container (vial) with
                                          rubber stopper protected with aluminium foil
                                          containing 1ml sterile aqueous single
                                          suspension of 150mg of medroxyprogesterone
                                          acetate in water for injection for IM use.
                                          Labelling of vial shall be in accordance with
                                          attached labelling specifications.
         5 Period of action               3 months; for this time period the serum level
                                          of medroxyprogesterone acetate should be
                                          continuously above 0.1 microg /L (0.025nMl/L)
                                          in order to inhibit ovulation.
         6 Contraception efficacy         0.3 (average pregnancy rates per 100 women-
                                          years).
         7 General requirement for        Sterile, complies with endotoxin test, pH and
           Injections and                 osmotic pressure adjusted. Please refer to the
           suspensions                    mentioned Pharmacopoeias.
                                          Any sediment formed during the storage must
                                          easily be re-dispersed through shaking. The
                                          suspension must be stable enough to allow
                                          measurement of proper dose. The particle size
                                          should be monitored during the production and
                                          appropriate for the kind of application.
         8 General requirements           The preparation must be manufactured
                                          according to GMP (Good manufacturing
                                          practice) and should be registered as a three-
                                          monthly injectable contraceptive in the country
                                          of manufacture and in Tanzania.
         9 Pharmacopoeia standards        USP, Ph.Eur./EP, BP or other standard
            (for preparation and          pharmacopoeias as recognized by Tanzania
            container including the       Food and Drugs Authority, Tanzania.
            closures)



                                  Sec.VII-3
10 Shelf life                    At least 36 months, of which at least 80% left at
                                 the time of arrival of the medicine
11 Special Instruction           Labelling on each unit should mention ‘msd
                                 logo’.




                         Sec.VII-4
2. SPECIFICATION OF DISPOSABLE SYRINGES WITH NEEDLES
             1 Name of the Item          Disposable syringe 3 parts luer lock with needle.
             2 Capacity of the syringe   2ml with coloured graduation lines on barrel in units of 0.1ml

             3 Description of syringe    Non-prefilled, transparent with graduation scale on the syringe.
                                         Bubble exclusion (Excessive air bubbles introduced during filling will be
                                         easily moved to the top of barrel by flicking the finger nail against the
                                         barrel and then expelled by depressing the plunger
                                         Aspiration for blood (When the syringe is filled with liquid to the
                                         maximum graduated capacity, sufficient flexibility will be provided to
                                         enable the plunger to withdrawn sufficiently to check for the present of
                                         blood. Aspiration will be possible at any position of the plunger within the
                                         graduated range.
             4 Size of the needle        21G x 1.5 (0.8mm x 40mm), with very sharp tip
             5 Package                   Each syringe with needle mounted or unmounted, should be packed in
                                         sterile peel-off blister pack or ribbon pouch made of paper and plastic.
                                         Sterilized by Ethylene oxide(EO). Primary packaging should be labelled
                                         with name of primary manufacturer, brand name, lot number,
                                         manufacturing and expiry dates coded quality manufacturing standard eg.
                                         ISO EN CE etc.
             6 Shelf life                At least 48 months, of which at least 80% left at the time of arrival of the
                                         Syringes with needle.



3. GENERAL REQUIREMENTS OF MEDROXYPROGESTERONE SUSPENSION 150MG/ML, SYRINGE AND NEEDLE




                                                           Sec.VII-5
1 General requirements    The preparation must be sterile and manufactured and tested in
                          accordance with manufacturing instructions, testing standards, GCP/GMP
                          (Good clinical practice/Good manufacturing practice) and should be
                          certified /registered as medical device in the country of manufacture.
                          (Attach certificate).




2 ISO - Standards         ISO 7886, ISO 7864 and ISO 13485.

3 Packing specification   One box should contain 100 vials packed in 10's in sealed polystyrene
                          boxes and 100 disposable syringes with needle.
                          One carton should carry 4 boxes




                                           Sec.VII-6
          5. GENERAL SPECIFICATION FOR PHARMACEUTICALS

1.   Product and      1.1   The Goods to be purchased by the Purchaser under
     Package                this Invitation for Bids are included in the Purchaser’s
     Specifications         current national essential drugs list or national
                            formulary. The required packing standards and label
                            must meet the latest requirements of the World
                            Health Organization (WHO) good manufacturing
                            practices (GMP) standards in all respects. (These
                            standards contained in “Good Practices in the
                            Manufacture and Quality Control of Drugs.”)

                      1.2   Product specifications indicate dosage form (e.g.,
                            tablet, capsules, dry syrup, liquid, ointment, injectable,
                            emulsion suspension, etc.) and the drug content (exact
                            number of mg or international units [IU] or % v/v, wlw
                            or v/w acceptable range).     The Goods should conform
                            to standards specified in the following compendia:
                            [The procuring entity should specify an accept
                            Pharmacopoeia standard from one of the following:
                            the British Pharmacopoeia, the United States
                            Pharmacopoeia, the French Pharmacopoeia, the
                            International     Pharmacopoeia      or    the    European
                            Pharmacopoeia, the latter particularly for raw
                            materials.] The standards will be the latest edition unless
                            otherwise stated by the Purchaser or other if applicable. In
                            case the pharmaceutical product is not included in
                            (the specified compendium, but included in the
                            Purchasers, national essential drug list, the Purchaser
                            should clearly indicate acceptable limits and the Supplier,
                            upon award of the Contract, must provide the
                            reference, standards and testing protocols to allow for
                            quality control testing.

                      1.3   Not only the pharmaceutical item, but also packaging
                            and labelling components (e.g., bottles, closures, and
                            labelling) should also meet specifications suitable for
                            distribution, storage, and use in a climate similar to
                            that prevailing in the United Republic of Tanzania.
                            All packaging must be properly sealed and tamper-
                            proof and packaging components must meet the latest
                            compendium standards and be approved for pharmaceutical
                            packaging by the manufacturer's national Regulatory


                                     Sec.VII-7
                          Authority (RA). The Purchaser should specify any
                          additional special requirements.

                    1.4   All labelling and packaging inserts shall be in the
                          language requested by the Purchaser or English if not
                          otherwise stated.

                    1.5   Goods requiring refrigeration or freezing or those that
                          should not fall below a certain minimum temperature for
                          stability    must     specifically   indicate     storage
                          requirements on labels and containers and be shipped
                          in special containers to ensure stability in transit from
                          point of shipment to port of entry.

                    1.6   Upon award, the successful Supplier shall, on
                          demand, provide a translated version in the language
                          of the bid of the prescriber's information for any
                          specific goods the Purchaser may request.

2.   Labelling      2.1   The label of the primary container for each
     Instructions         pharmaceutical and vaccine products shall meet the
                          W210 GMP standard and include:

                          (a)   the international non-proprietary name (INN)
                                or generic name prominently displayed and
                                above the brand name, where a brand name
                                has been given. Brand names should not be
                                bolder or larger than the generic name;

                          (b)   dosage form, e.g., tablet, ampoule, syrup, etc.;

                          (c)   the active ingredient "per unit, dose, tablet or
                                capsule, etc.";

                          (d)   the applicable pharmacopoeial standard;

                          (e)   the Purchaser's logo and code number and any
                                specific colour coding if required;

                          (f)   content per pack;

                          (g)   instructions for use;

                          (h)   special storage requirements;

                          (i)   batch number;



                                  Sec.VII-8
                             (j)         date of manufacture and date of expiry (in clear
                                         language, not code);

                             (k)         name and address of manufacture; and

                             (l)         Any additional cautionary statement.

                       2.2   The outer case or carton should also display the above
                             information.

3.   Case              3.1   All cases should prominently indicate the following:
     Identification
                                   (a) Purchaser's line and code numbers;

                                   (b) the generic name of the product;

                                   (c) the dosage form (tablet, ampoule, syrup);

                                   (d) date of manufacture and expiry (in clear
                                       language not code);

                                   (e) batch number;

                                   (f) quantity per case;

                                   (g) special instructions for storage;

                                   (h) name and address of manufacture; and

                                   (i) any additional cautionary statements.

                       3.2   No case should contain pharmaceutical products from
                             more than one batch.

4.   Unique            4.1   The Purchaser shall have the right to request the
     Identifiers             Supplier to imprint a logo, if the quantity so justifies
                             it, on the labels of the containers used for packaging and
                             in certain dosage forms, such as tablets, and ampoules
                             and this will be in the Technical Specifications. The
                             design and detail will be clearly indicated at the time of
                             biding, and confirmation of the design of such logo shall be
                             provided to the Supplier at the time of contract award.

5.   Standards of      5.1   The successful Supplier will be required to furnish to
     Quality Control         the Purchaser:
     for Supply
                                   (a)     With each consignment, and for each item a


                                          Sec.VII-9
                WHO certificate of quality control test
                results concerning quantitative assay,
                chemical analysis, sterility, pyrogen content
                uniformity, microbial limit, and other tests,
                as applicable to the Goods being supplied
                and the manufacturer's certificate of
                analysis;

         (b)    Assay methodology of any or all tests if
                requested;

         (c)    Evidence of bio-availability and/or bio-
                equivalence for certain critical Goods upon
                request. This information would be supplied on
                a strictly confidential basis only; and

         (d)    Evidence of basis for expiration dating and
                other stability data concerning the
                commercial final package upon request.

5.2   The Supplier will also be required to provide the
      Purchaser with access to its manufacturing facilities to
      aspect the compliance with the GMP requirements
      and quality control mechanisms.




               Sec.VII-10
           TECHNICAL SPECIFICATION FOR PHARMACEUTICALS
                        (Additional Information)


1.   Product quality and Package Specifications

     1.1    Product specification should indicate dosage form (e.g., tablet, liquid,
            injection, emulsion, suspension, etc.) and the drug content (exact
            number of mg or % v/v per doses with acceptable range). The product
            should conform to standards specified in the latest edition of one of the
            following compendia: the British Pharmacopoeia (BP), the United State
            Pharmacopoeia (USP) European Pharmacopoeia (EP) or the
            International Pharmacopoeia (IP). In case the pharmaceutical is not
            included in the specified compendium, the supplier must provide the
            reference standards and testing protocols to allow for quality control
            testing.

     1.2    The following information must be submitted with the bid:

            i.     Certificates of pharmaceutical products according to WHO 41.18
                    “Certification scheme on the quality of pharmaceutical product
                    moving in international commerce” must be enclosed.

                    Copies of registration certificates of registered products for
                     human medicines” for products tendered issued by the
                     Tanzania Food and Drug Authority (TFDA).

            ii.    Otherwise bidders shall submit copies of the following
                    documents:
                    - A receipt of registration fee issued by the Tanzania Food and Drug
                        Authority (TFDA).

                    -    A letter of acknowledgement from the TFDA that the drug dossier
                          and sample have been received.

                    -   Copy of certificate of pharmaceutical product from Drug Regulatory
                         Authority (DRA) in the country of origin.

                          Note that:
                          By the time of contract signing the successful bidder shall
                          submit the registration certificate for the goods to be
                          supplied under the contract, issued by the Tanzania Food
                          and Drug Authority (TFDA).

            iii.    Description of primary packing material (i.e. PP-bottle 100 ml
                    w/screw cap).




                                        Sec.VII-11
      iv.    The required packing standards and labelling of pharmaceuticals
             must meet the WHO Good Manufacturing Practices ("GMP")
             standard in all respects.

      v.     Alternative specifications to meet functional requirements will
             be considered, but must be submitted separate from, and not on
             the schedule of quantities and must be limited to a maximum of
             two offers including the quoted offer.

1.3   The packaging components (e.g., bottles and closures) should meet
      specifications suitable for the purpose and have no detrimental effects
      on the pharmaceutical product Primary packing materials must give
      adequate protection against external influence and potential
      contamination. All light sensitive pharmaceutical should be packed in
      amber or opaque containers to give maximum protection from light.

      Tablets and capsules should be packed in sealed, waterproof containers
      with replaceable lids that protect the contents against light and
      humidity. For drugs supplied in tins, priorities will be given to tablets
      packed in vacuum packing inside the tins.

1.4   Secondary packaging material should be strong enough to resist
      breakages during transportation and normal handling.

      Bottles should be packed as follows:
       100 ml bottles dry powder for suspension in not more than 100
         units per carton
       100 ml bottles liquid syrups/suspensions in not more than 24 units
         per carton
       5 litres bottles in not more than 4 units per carton

      Eye drops should not be packed more than 30 units per carton, and if
      more than 10 units, the box must be partitioned.

      Ampoules/ vials must be packed in units of 10 in sealed boxes and
      each ampoule/vials must be marked with the product name, strength,
      batch number, manufacture and the expiry date. Instruction leaflets
      should be inserted.


All packing must be properly sealed and tamper-proof.

1.5   Pharmaceuticals requiring refrigeration of freezing for stability must
      specifically indicate storage requirements on labels and containers and
      be shipped in special container to ensure stability in transit from point
      of shipment to Medical stores Department (MSD).



                               Sec.VII-12
2.     Manufacture and expiration date
       All products must indicate the dates of manufacture and expiry in a clear
       language note codes. In additional all products must arrive at the port/airport
       of Dar es Salaam with a remaining shelf life of at least 80% of the total
       stipulated shelf life at the time of manufacture.

3.     Qualifications of Manufacturer

       The Supplier shall furnish a certificate from the competent authority such as
       Food and Drug Authority (FDRA) that the manufacturer of the
       pharmaceuticals is licensed to manufacture these products.

4.     Standards and Quality Assurance for Supply

       4.1    All products must:

a) Meet the requirements of manufacturing legislation and regulation of
   pharmaceuticals in the country of origin.
b) Conform to all the specifications contained herein.
c) Be certified by a competent authority in the manufacturer's country according to
   resolution WHO 28-65B, of the World Health Organization "Certifications Scheme
   on the Quality of Pharmaceuticals Products Moving International Commerce"

       6.2    The Supplier will also be required, if requested, to provide the
              purchaser with access to its manufacturer facilities to inspect its
              facilities, quality control procedures for raw materials, test methods, in-
              process tests, and finished dosage forms.


5.     Recalls
In the event any of the Goods are recalled, the Supplier shall notify the Purchaser
within fourteen (14) days, providing full details of the reason for the recall and
promptly replace, at its own cost, the items covered by the recall with Goods that
fully meet the requirements of the Technical Specification and arrange for collection
or destruction of any defective Goods. If the Supplier fails to fulfil its recall obligation
promptly, the Purchaser will, at the Supplier’s expense, carry out the recall.




                                         Sec.VII-13

				
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