In the contract document7, or when placing an order, a NTP manager or his/her responsible staff should clearly state the product specifications as per the packaging and labelling requirements detailed below.
7 An example of a bid document: Standard Bidding Documents. Procurement of Goods. Washington, The World Bank, 1995. Revised March 2002. Available at URL: http://www.worldbank.org/html/opr/biddocs/contents.html
• The International Nonproprietary Name(s) (INN) (or generic name) of the active ingredient(s);
• The designated name of the product if applicable;
• The pharmacopoeial standard that applies to each active ingredient;
• Requirements as to bio-availability/bio-equivalence for rifampicincontaining FDCs (see section 4.2);
• The strength of the active ingredient(s) per dosage unit (e.g. for the 4-drug FDCs, it is advised that the WHO-recommended dosage strength be used, i.e. R150 mg/H75 mg/Z400 mg/E275 mg per tablet);
• The dosage form and package details;
• The storage conditions and precautions, where applicable;
• The shelf-life.
Packaging and labelling requirements:
• The language to be used for all packaging and labelling;
• The name of the product;
• Adescription of its pharmaceutical form, strength and method of application;
• The pack size expressed in terms of the number, weight, or volume of the product per pack or container;
• Special storage conditions if goods are to be shipped in special containers, to ensure stability of the products;
• Preferred packaging, e.g. blister-packs, loose tablets, patient kit.
• The INN or generic name;
• The designated name of the product, if applicable;
• The dosage form, e.g. tablet, ampoule, vial;
• The strength of the active ingredient(s) per dosage unit;
• The applicable pharmacopoeial standard;
• The content per pack;
• Instructions for use;
• The batch number;
• Special storage requirements;
• The date of manufacture and expiry date (in clear language, not code);
• The full name and address of the manufacturer.