Inspections are part of the overall quality assurance system for medicines. Inspections are essential to evaluate commercial manufacturing capability, adequacy of manufacturing and control procedures, suitability of equipment and facilities, and effectiveness of the quality management system in assuring the overall state of GMP/GDP compliance. Inspections include evaluation of authenticity, and the monitoring of the quality of medicines in legitimate distribution channels, from their manufacture to end delivery.
Our aim to include foreign and domestic establishments with the greatest public health risk potential in case of a manufacturing and/or transportation failings.For us, the best inspection approach includes cooperative arrangements among competent national regulatory authorities to enable broader inspection coverage and sharing of inspection results.
