With the publication of the 52nd Technical Report Series No. 1010 of the WHO, eleven Guidelines were adopted and recommended for use:
In the area of Quality Assurance – GMP:
- WHO guidelines on good herbal processing practices for herbal medicines (Annex 1)
- WHO good manufacturing practices for herbal medicines (revision) (Annex 2)
- Guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems (revision) (Annex
- Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions (Annex 9)
- Stability testing of active pharmaceutical ingredients and finished pharmaceutical products (revision) (Annex 10)
- Considerations for requesting analysis of medicines samples (revision) (Annex 3)
- WHO model certificate of analysis (revision) (Annex 4)
- WHO guidance on testing of “suspect” falsified medicines (Annex 5)
- Good pharmacopoeial practices: Chapter on compounding (Annex 6)
- Good pharmacopoeial practices: Chapter on monographs on herbal medicines (Annex 7)
- Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities (Annex 11).
Source:
WHO: Essential Medicines and Health Products