Click here for search results

Health Sector Goods - Section VII. Technical Specifications

Section VII. Technical Specifications

Notes for Preparing the Technical Specifications
[Procurement Specific]

A set of precise and clear specifications is a prerequisite for Bidders to respond realistically and competitively to the requirements of the Purchaser without qualifying their bids. The sample text provided in this section should serve as guidance only. This text is not intended to be used verbatim since technical specifications specific to each procurement should be drafted by the Purchaser for inclusion in the bidding documents. In the context of international competitive bidding (ICB) among qualified firms, the specifications must be drafted to permit the widest possible competition. The technical specifications establish the requirements for good manufacturing practices (GMPs), pharmacopoeial standards, nomenclature, and description required for each product, shelf life and package expiration date parameters, labeling instructions, packaging instructions, GMP and quality assurance certificates required, and other evidence of product quality to be submitted with the bid and with each shipment. Only if this is done will the objectives of economy, efficiency, and fairness in procurement be realized, responsiveness of bids be ensured, and the subsequent task of bid evaluation facilitated.

Specific pharmacopoeial standards should be listed for each product; if any of a range of standards is adequate (British Pharmacopoeia, United States Pharmacopoeia, European Pharmacopoeia, or International Pharmacopoeia), this should be noted. If special packaging or labeling is required for a subset of products, this should be indicated on the schedule of requirements (see above), but a generic statement of packaging and labeling applied to all products should be included in the general technical specifications. Instructions about labeling (contents and language) and package inserts can be included in the technical specifications, unless there are specific requirements for each batch or schedule of requirements.

Technical Specifications

[Text of Technical Specifications to be inserted in the Bidding Documents by the Purchaser, as applicable.]

Technical Specifications:

 

Technical Specifications:

 

Technical Specifications:

Pharmaceuticals

Condoms

Vaccines

 

Sample Technical Specifications

Pharmaceuticals

1. Product and Package Specifications

1.1 The Goods to be purchased by the Purchaser under this Invitation for Bids are included in the Purchaser¬タルs current national essential drugs list or national formulary. The required packing standards and labeling must meet the latest requirements of the World Health Organization (WHO) good manufacturing practices (GMP) standards in all respects. (These standards are 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, w/w or v/w acceptable range). The Goods should conform to standards specified in the following compendia: [The Borrower should specify an acceptable 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 Purchaser¬タルs 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 the packaging and labeling components (e.g., bottles, closures, and labeling) should also meet specifications suitable for distribution, storage, and use in a climate similar to that prevailing in the country of the Purchaser. 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¬タルs national regulatory authority (RA). The Purchaser should specify any additional special requirements.

 

1.4 All labeling 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¬タルs information for any specific goods the Purchaser may request.

2. Labeling Instructions

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

  1. The international nonproprietary 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;

  2. dosage form, e.g., tablet, ampoule, syrup, etc.;

  3. the active ingredient "per unit, dose, tablet or capsule, etc.";

  4. the applicable pharmacopoeial standard;

  5. the Purchaser¬タルs logo and code number and any specific color coding if required;

  6. content per pack;

  7. instructions for use;

  8. special storage requirements;

  9. batch number;

  10. date of manufacture and date of expiry (in clear language, not code);

  11. name and address of manufacture;

  12. any additional cautionary statement.
 

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

3. Case Identification

3.1 All cases should prominently indicate the following:

  1. Purchaser¬タルs line and code numbers;

  2. the generic name of the product;

  3. the dosage form (tablet, ampoule, syrup);

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

  5. batch number;

  6. quantity per case;

  7. special instructions for storage;

  8. name and address of manufacture;

  9. any additional cautionary statements.
 

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

4. Unique Identifiers

4.1 The Purchaser shall have the right to request the 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 bidding, and confirmation of the design of such logo shall be provided to the Supplier at the time of contract award.

5. Standards of Quality Control for Supply

5.1 The successful Supplier will be required to furnish to the Purchaser:

  1. With each consignment, and for each item a 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¬タルs certificate of analysis.

  2. Assay methodology of any or all tests if requested.

  3. 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.

  4. 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 inspect the compliance with the GMP requirements and quality control mechanisms.


Sample Technical Specification
Vaccines

1. Product Qualification Requirements

Option A

1.1 The Goods to be purchased by the Purchaser under this Invitation for Bids must be produced under the control of a recognized, well-functioning National Control Authority (NCA) for biologicals, which performs all six critical functions as defined by the World Health Organization (WHO):

 

  1. licensing based on published set of requirements

  2. surveillance of vaccine field performance

  3. system of lot release for vaccines

  4. use of laboratory when needed

  5. regular inspections for good manufacturing practices (GMP)

  6. evaluation of clinical performance

Or state the following:

Option B

1.1 The Goods under this Invitation for Bids should be purchased from WHO-approved sources only.

 

1.2 The Goods to be purchased by the Purchaser under this Invitation for Bids must be produced in accordance with the GMP recommendations of WHO for biological products.

 

1.3 The Goods to be purchased by the Purchaser under this Invitation for Bids must be registered by the National Control Authority (NCA) of the Purchaser¬タルs country.

2. Product Specifications

2.1 Dosage form (e.g.: oral or injectable; liquid or freeze dried with sterile diluent packed separately, etc.).

 

2.2 Type (e.g.: "live attenuated," "manufactured from purified inactivated (...) obtained from human plasma or manufactured using recombinant DNA technology," etc.).

 

2.3 Administration (e.g.: "intended for intramuscular injection," etc.).

 

2.4 Description of intended use (e.g.: "immunization of newborn infants," etc.).

 

2.5 Dosage size (if not restrictive), or expected immunogenic reaction (e.g.: each dose shall contain that amount of Hbsag protein with micrograms/ml specified by the manufacturer for newborn dosage, that when given as part of a primary immunization series [3 doses] is capable of producing specific humoral antibody [anti HBs] at a level of at least 10 milli international units in >-90 percent of recipients," etc.).

 

2.6 Dose package (e.g.: "5 infant dose sterile glass vials," etc.).

 

2.7 Filling volume (e.g.: "final product should contain 15% overfill," etc.).

 

2.8 Closures (e.g.: "vaccine vials shall be fitted with closures that conform to ISO standard 8362-2").

 

2.9 Storage temperature (e.g.: "2¬タモ8 degrees C. Do not freeze," or as appropriate, etc.).

 

2.10 The product should remain stable up to the indicated test expiry date if kept according to the required storage temperature.

 

2.11 Standards (e.g.: "The vaccine should conform to standards established by the Purchaser¬タルs country or, where no standard has been adopted, meet current requirements published by the WHO Expert Committee on Biological Standardization, or requirements of an established body of equivalent stature such as the U.S. Pharmacopoeia, the British Pharmacopoeia, the French Pharmacopoeia, or the International Pharmacopoeia").

3. Labeling Requirements

3.1 Each vial or ampoule shall carry the manufacturer¬タルs standard label in the language of Purchaser¬タルs country, if available at no extra charge; otherwise, the label shall be in English.

 

3.2 Each vial or ampoule label shall state the following:

  1. name of the vaccine;

  2. name of the manufacturer;

  3. place of manufacture;

  4. lot number;

  5. composition;

  6. concentration;

  7. dose mode for administration;

  8. expiration date;

  9. storage temperature;

  10. any other information that is appropriate.
 

3.3 All labeling shall withstand immersion in water and remain intact.

4. Packing Requirements

4.1 Inner boxes: Inner Boxes shall contain not more than (number) individual vials/ampoules and shall be constructed of sturdy white cardboard outfitted with individual segments for protecting and separating each vial/ampoules.

 

4.2 Printed materials: Each inner box shall contain at least (number) manufacturer¬タルs standard package inserts in the language of Purchaser¬タルs country if available at no extra charge; otherwise, package insert shall be in English.

 

4.3 Overpacking: Inner boxes shall be overpacked so that the vaccine remains refrigerated as designated in Clause 2.9. The overpacking must be suitable for export handling and be in accordance with WHO Expanded Program of Immunization (EPI) Guidelines on International Packaging and Shipping of Vaccines including all measures needed to maintain required temperatures for seventy-two (72) hours. It must have adequate insulation and sufficient refrigerant to ensure that the warmest storage temperature of the vaccine does not rise above that designated in Sub-Clause 2.9 when exposed to continuous outside temperature of +43 degrees C, nor fall below that specified of -20 degrees C during transit and for a period of at least twenty-four (24) hours after arrival at the airport destination. Additional cushioning shall be provided sufficient to protect the vials/ampoules from breakage during transit and handling.

 

4.4 Exterior shipping cartons: Product and printed materials, packaged as described above, shall be packed in weather-resistant, triple-wall corrugated fiberboard cartons with a bursting test strength of not less than 1,900 kPa. The overall dimensions of the exterior shipping cartons should be such that the product does not become damaged during transportation and storage.

No shipping carton should contain vaccine from more than one lot.

 

4.5 Cold chain monitor cards: Each insulated shipping container must include appropriate temperature-monitoring devices designated by the Purchaser.

 

  1. At least two suitable cold chain monitor cards, as approved by the Purchaser, shall be packed in each transport case of vaccine.

  2. Freeze watch indicators shall be included in each transport case at the direction of Purchaser.

5. Marking Requirements

5.1 All containers and invoices must bear the following information:

  1. the name of the vaccine;

  2. expiration date of the vaccine;

  3. appropriate storage temperature.
 

5.2 Inner boxes: The inner boxes containing vaccine vials or ampoules shall be marked with the following information in a clearly legible manner that is acceptable to the Purchaser:

 

  1. Generic name and trade name of the vaccine;

  2. Manufacturer¬タルs name and trade registered address;

  3. Manufacturer¬タルs national registration number;

  4. Lot or batch number;

  5. Composition and concentration;

  6. Number of vials contained in box;

  7. Expiration date (month and year in clear language, not code);

  8. Instructions for storage and handling;

  9. Place of manufacture (Made in ______).
 

5.3 Exterior Shipping Cartons: The following information shall be stenciled or labeled on the exterior shipping cartons on two opposing sides in bold letters at least 30mm high with waterproof ink in a clearly legible manner that is acceptable to the Purchaser.

 

  1. Generic name and trade name of the vaccine;

  2. Lot or batch number;

  3. Expiration date (month and year in clear language, not code);

  4. Manufacturer¬タルs name and registered address;

  5. Manufacturer¬タルs national registration number;

  6. Destination airport and routing;

  7. Consignee¬タルs name and address in full;

  8. Consignee contact name and telephone number;

  9. Number of vials or ampoules contained in the carton;

  10. Gross weight of each carton (in kg);

  11. Carton #____ of _____;

  12. Instructions for storage and handling;

  13. Contract number;

  14. Place of manufacture (Made in______).

6. Quality Control for Supply

6.1 All goods must:

  1. meet the requirements of manufacturing legislation and regulation of vaccines in the country of origin;

  2. meet internationally recognized standards for safety, efficacy, and quality;

  3. conform to all the specifications and related documents contain herein;

  4. be fit for the purposes expressly made known to the Supplier by the Purchaser;

  5. be free from defects in workmanship and materials; and

  6. be certified by a competent authority in the manufacturer¬タルs country according to resolution WHA 28-65(2), of the WHO release certificate.
 

6.2 The Supplier will be required to furnish to the Purchaser with each consignment;

 

  1. A certificate of quality control and test results in conformity with the WHO release certificate.

  2. Assay methodology of any or all tests if required.

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

6.3 Preshipment inspection and testing: The Supplier will be required to provide the Purchaser or his representative with access to the product as packed for shipment at the sellers¬タル factory and/or warehouse at a mutually agreeable time prior to shipment of the product.

 

  1. The Purchaser may inspect and sample, or cause to be sampled, such product.

  2. The Purchaser may cause independent laboratory testing to be performed as deemed necessary to ensure that the Goods conform to prescribed requirements. The testing laboratory shall be of the Purchaser¬タルs choice and suitably equipped and qualified to conduct quality control test on biological products.


Sample Technical Specifications
Condoms

1. Product and Package Specifications

1.1 The Goods must conform to the manufacturer¬タルs current standards for condoms and specified in line with the ISO 4074 Standard for Latex Rubber Condoms.

 

1.2 The specifications for the Goods shall indicate critical factors, i.e., bursting volume and pressure, freedom from holes, width and length, thickness, lubricant quality, and viscosity.

 

1.3 The Goods and packaging and labeling components shall meet the standards specified in the latest WHO specification, including batch-by-batch independent quality control laboratory tests.

 

1.4 Condoms should be shipped in special containers to ensure stability in transit from point of shipment to port/air port of entry and point of destination for CIP deliveries. Any special temperature requirements must be designed to meet the climatic conditions prevailing in the country of the Purchaser, and the Purchaser should advise the Supplier of any particular requirements.

2. Labeling

2.1 The primary pack should be labeled in accordance with the latest WHO specifications and include:

 

  1. Manufacturer¬タルs name;

  2. Batch number (printed at the time of packaging);

  3. Month and year of expiry; and

  4. Any other information as requested by the Purchaser.
 

2.2 The secondary packing, i.e., the inner box, should be labeled in accordance with the latest WHO specifications and include:

  1. Batch number;

  2. Month and year of manufacture (including the words: Date of Manufacture/month/year);

  3. Manufacturer¬タルs name and registered address;

  4. Nominal width expressed in millimeters;

  5. Number of condoms in box;

  6. Instructions for storage; and

  7. Month and year of expiry.

3. Packaging Specification

3.1 All exterior shipping cartons and packaging must comply with the latest WHO specification for packaging of condoms.

4. Case Identification

4.1 All cases should predominantly indicate the following:

 

  1. Batch number;

  2. Month and year of manufacture (including the words: Date of Manufacture/month/year);

  3. Name and address of supplier;

  4. Nominal width expressed in millimeters;

  5. Number contained in the carton;

  6. Instructions for storage and handling; and

  7. Month and year of expiry.

5. Lot Traceability

5.1 All exterior shipping cartons for each batch should be assembled and shipped together to facilitate the monitoring of batch quality during shipping and storage.

 

5.2 Both codes should be used on exterior shipping cartons, color coded for ease of identification if requested by the Purchaser.

6. Unique Identifiers

6.1 The Purchaser will have the right to request the Supplier to imprint, provided the quantity justifies it, a logo on the packaging of the condoms. The design and details will be clearly indicated at the time of bidding and shall be provided to the Supplier at the time of contract award.

7. Standards of Quality Control for Supply

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

8. Quality Control Testing

8.1 (a) The Supplier shall be required to carry out testing of a proposed shipment in line with the WHO specification, and the size of sample will be calculated by reference to ISO 2859-1.

(b) With each consignment the Supplier must provide a certificate of quality control test results in conformity with the WHO specifications and in accordance with the general sampling levels appropriate to each feature as necessary.