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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...

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Publicado en:WHO Drug Information Vol. 35; no. 3; pp. 662 - 684
Formato: Journal Article
Publicado: World Health Organization 2021
Acceso en línea:Ver este registro en EBSCOhost
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        atl: WHO GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS.
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        subj:
          World Health Organization Standards
          Drugs, Investigational Standards
          Drug Compounding Standards
          Pharmaceutical Companies Standards
          COVID-19 Drug Therapy
          Practice Guidelines
          Quality Control (Technology)
          Clinical Trials
          Risk Management
          Documentation
          Drug Labeling
          Drug Packaging
          Product Recall
          Drug Storage
      ab: 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.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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