Inspection and surveillance enable drug regulatory authorities to monitor whether pharmaceutical operations are carried out in accordance with approved standards and guidelines. In so doing, they uncover weaknesses and actual errors in drug production, QC, storage and distribution of drugs. Activities include physical inspection and quality-testing of product samples. In order to perform these duties, inspectors should be assigned the necessary legal powers. They should also be suitably qualified and free from conflicts of interest and political pressure.
This chapter assesses the situation in the 10 countries with respect to GMP inspection and inspection of distribution channels.