Publisher's Synopsis
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines.
Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: - WHO guidelines on good herbal processing practices for herbal medicines;- Guidelines on good manufacturing practices for the manufacture of herbal medicines;
- Considerations for requesting analysis of medicine samples;
- WHO model certificate of analysis;
- WHO guidance on testing of "suspect" falsified medicines;
- Good pharmacopoeial practices - Chapter on monographs for compounded preparations;
- Good pharmacopoeial practices - Chapter on monographs on herbal medicines;
- Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products;
- 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;
- Stability testing of active pharmaceutical ingredients and finished pharmaceutical products; and
- Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.
