The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The Setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization’s functions that it should develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products.


Contents:

1. WHO good manufacturing practices: main principles for pharmaceutical products
Quality management in the drug industry: philosophy and essential elements
Heating Ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
Validation
Water for pharmaceutical use

2. WHO good manufacturing practices: starting materials
Active pharmaceutical ingredients (bulk drug substances)
Pharmaceutical excipients

3. WHO good manufacturing practices: specific pharmaceutical products
Sterile pharmaceutical products
Biological products
Investigational pharmaceutical products for clinical trials in humans
The manufacture of herbal medicines
Radiopharmaceutical products

4. Inspection
Pre-approval inspections
Inspection of pharmaceutical manufacturers
Inspection of drug distribution channels
Quality systems requirements for national good manufacturing practice inspectorates
Guidance on good manufacturing practices: inspection report
Model certificate of good manufacturing practices

5. Hazard and risk analysis in pharmaceutical products
Application of hazard analysis and critical control point (HACCP) methodology to pharmaceuticals

6. Sampling operations (new)
Sampling of pharmaceutical products and related materials