Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs: 3. FDC DRUG MANAGEMENT: 3.2 Procurement: 3.2.4 Minimum product specifications, packaging and labelling requirements to be specified in the contract

Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs
(2002; 81 pages)

Table des matières

ACKNOWLEDGEMENTS
LIST OF ACRONYMS AND ABBREVIATIONS
PREFACE
KEY POINTS
1. INTRODUCTION
	1.1 Aim and objectives
	1.2 What you can find in this guide
	1.3 Background and rationale
2. PROGRAMMATIC AND MANAGERIAL REQUIREMENTS FOR FDCS
	2.1 DOTS strategy
		2.1.1 Challenges in TB control
		2.1.2 Why switch to FDCs?
		2.1.3 FDCs and adverse effects
		2.1.4 Directly observed treatment and FDCs
	2.2 FDC formulations in the WHO Model List of Essential Medicines
	2.3 Treatment regimens using FDCs
	2.4 Justification for dosage forms and dosage schedules
3. FDC DRUG MANAGEMENT
	3.1 Product selection
	3.2 Procurement
		3.2.1 Quantification of drug needs
		3.2.2 Procurement methods and selection of suppliers
		3.2.3 Procurement and quality assurance
		3.2.4 Minimum product specifications, packaging and labelling requirements to be specified in the contract
	3.3 Distribution and storage
	3.4 Rational use of anti-TB medicines
	3.5 Drug problem reporting system
	3.6 Monitoring and evaluation
	3.7 Summary checklist for good anti-TB drug management
4. ENSURING THE QUALITY OF FDC DRUGS
	4.1 Building a quality assurance system for the national TB programme
		4.1.1 Quality assurance where there is an operational drug regulatory authority
		4.1.2 Quality assurance where there is no national drug regulatory authority or no operational drug registration system
	4.2 Bio-availability and bio-equivalence (interchangeability) data
	4.3 Laboratory testing
	4.4 The WHO Certification Scheme
	4.5 Facilitating the drug registration process
5. HOW TO INTRODUCE AND CHANGE OVER TO A REGIMEN WITH 4-DRUG FDCS/2-DRUG FDCS: PLANNING AND IMPLEMENTING A "SCENARIO"
	5.1 The challenge
	5.2 Planning
	5.3 The process
		5.3.1 Decision-making phase
		5.3.2 Preparation
		5.3.3 Initial implementation
		5.3.4 Full implementation
Annex 1. Glossary and use of terms
Annex 2. WHO Certification Scheme - Model Certificate of a Pharmaceutical Product¹
Annex 3. WHO Certification Scheme - Model Batch Certificate of a Pharmaceutical Product
Annex 4. Example of an order form for anti-TB drugs for treatment facilities
Annex 5. Steps in the quantification of anti-TB drugs using consumption-based information
Annex 6. Suggested reading
Request for feedback on the guide

3.2.4 Minimum product specifications, packaging and labelling requirements to be specified in the contract

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

Product specifications:

• 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.

Labelling specifications:

• 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.