The Kenya National Drug Policy: 7. QUALITY ASSURANCE: 7.2. Good Manufacturing Practices

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The Kenya National Drug Policy (WHO; 1994; 27 pages)
	FOREWORD
	ABBREVIATIONS
	1. GOAL AND OBJECTIVES OF THE NATIONAL DRUG POLICY
		1.1. The Goal of the National Drug Policy
		1.2. Specific objectives of the NDP
	2. PUBLIC SECTOR DRUG SUPPLY
		2.1. Essential Drugs List
		2.2. Essential Medical Supplies and Appliances
		2.3. Financing
		2.4. Procurement
		2.5. Distribution
	3. DRUG SUPPLY BY THE PRIVATE SECTOR & NON-GOVERNMENTAL ORGANISATIONS
		3.1. Adoption of the Essential Drugs Concept
		3.2. Generic Labelling
		3.3. Institutional and Retail Pharmacy Services
		3.4. Prescribing and Dispensing
		3.5. Drug Donations
		3.6. Financing and Pricing of Drugs in the Private and NGO Sectors
	4. VETERINARY DRUG SUPPLY
		4.1. Selection and Supply of Veterinary Drug
		4.2. Financing
	5. REGULATORY CONTROL
		5.1. Drug Control and Administration
		5.2. Drug Registration
		5.3. Scheduling of Drugs
		5.4. Pharmaceutical Inspectorate
		5.5. Clinical Trials
		5.6. Traditional Medicine
		5.7. Professional Associations and Professional Ethics
	6. RATIONAL DRUG USE
		6.1. Prescription Practices
		6.2. Treatment Guidelines
		6.3. Generic Prescribing
		6.4. Education and Training
		6.5. Pharmacy and Therapeutic Committees
		6.6. Drug Information
		6.7. Drug Advertising and Promotion
	7. QUALITY ASSURANCE
		7.1. National Quality Control Laboratory
		7.2. Good Manufacturing Practices
		7.3. Certification Schemes on the Quality of Pharmaceuticals
	8. DRUG ABUSE
	9. IMPORTATION AND EXPORTATION OF DRUGS
		9.1. Importation of Drugs
		9.2. Exportation of Drugs
	10. LOCAL PRODUCTION
		10.1. Local Manufacture
		10.2. Patents
		10.3. Research and Development
	11. MANPOWER TRAINING AND DEVELOPMENT
	12. LEGISLATION
	13. MONITORING & EVALUATION
	14. INTERSECTORAL AND TECHNICAL COOPERATION

7.2. Good Manufacturing Practices

All manufacturers will be required to adhere to internationally accepted standards for current Good Manufacturing Practices (GMP).

The location, architectural design and construction of a pharmaceutical factory will be subject to specified minimum requirements. Such requirements should be consistent with standards which will meet international validation criteria acceptable to the Pharmacy and Poison Board.

The Pharmacy and Poisons Board will establish criteria for personnel to man quality assurance and production sections of a pharmaceutical manufacturing facility.

Adherence to GMP and quality assurance policies will be enforced by the QA-GMP team in the Pharmacy Inspectorate of Department of Pharmacy, according to international guidelines.

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