- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > GMP inspection
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > manufacturing standards
- Mots-clés > pharmaceutical manufacturing system
- Mots-clés > quality assurance - medicines
- Mots-clés > quality management systems (QMS)
- Mots-clés > substandard drugs
- Mots-clés > validation - manufacturing process
(2015; 24 pages)
A high number of substandard medicinal products are causing severe health impacts on patients, especially in developing countries. Too frequently, cases of people being severely affected or even dying due to the consumption of sub-standard medicines occur. Significant reasons for the presence of such products are inadequate adherence to and enforcement of unified, internationally acceptable standards for Good Manufacturing Practices (GMP).
This white paper explains UNIDO’s approach to developing a country-specific, achievable roadmap towards internationally acceptable GMP standards, such as those issued by the World Health Organization (WHO). The document points out the need for a risk-based, phased roadmap towards WHO GMP compliance and explains required steps and tools for its development. The recommended development process involves consultation with key stakeholders in the country concerned, and can be outlined as follows:
- Collecting baseline data on existing manufacturing practices
- Evaluation of gathered information and identification of the main common technical challenges
- Design of a GMP roadmap based on the evaluation results The white paper also highlights the various benefits of a risk-based, phased GMP roadmap for the pharmaceutical sector in developing countries and describes the prospects of aligning the UNIDO approach with other stakeholders’ activities in the future. Finally, the document outlines an example for the successful application of the roadmap concept in a developing country as evidenced by the implementation of the Kenya GMP Roadmap.