Asian Journal Of Social Pharmacy

Abstract: Objective To analyze the effectiveness deficiency of supplier on-site audit of pharmaceutical manufacturers, and to put forward detailed and feasible improvement measures. Methods A research method of “raising problems – analyzing problems – solving problems” was mainly adopted. That was, first, the existing problems in supplier on-site audit were presented according to GMP regulations. Then the causes were analyzed according to the actual situation of pharmaceutical manufacturers. Finally, improvement measures were raised. Results and Conclusion The improvement measures were proposed, including making a reasonable annual audit plan and audit scheme, improving the effectiveness of communication and carrying out on-site audit discussion CAPA, to promote the effectiveness of supplier on-site audit, achieve the objectives of on-site audit and supplier management.

Key words: supplier on-site audit, effectiveness, risk assessment