WHO GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS.
In view of an old publication date, and the recent need for new guidelines arising from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) Prequalification Team - Inspection Services (PQT INS) raised the urgency for a revision of the WHO Good manufacturing practic...
| Publicado en: | WHO Drug Information Vol. 35; no. 3; pp. 662 - 684 |
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| Formato: | Journal Article |
| Publicado: |
World Health Organization
2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| Sumario: | In view of an old publication date, and the recent need for new guidelines arising from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) Prequalification Team - Inspection Services (PQT INS) raised the urgency for a revision of the WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans (1). The Fifty-fifth Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) concurred with this proposal. The objective of this update is to bring the guideline in line with current expectations and trends in good practices and to harmonize the text with the principles from other related international guidelines. |
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