The self inspection program is an a

The self inspection program is an annual/periodic plan for self inspections and is applicable to all departments of the company in order to keep control of the GMP compliance of the company. The planning and execution of self inspections is based on existing requirements from CFDA, Company specific Guidelines, SOPs and other regulating documents, the content is drawn up by the self inspection team and the members of the self inspection team are selected based on their different competences and come from both manufacturing, QC and QA.Wherever GMP deficiencies are detected during self inspections these are dealt with within the existing quality systems.An annual summary and evaluation of the self inspection program is made to have as a basis for forthcoming programs.QA is rsponsible for the training and maintenance of he self inspection system.QA is also rsponsible for the establishment and accomplishment of the self inspection program.The self inspection team is jointly responsible for execution, reporting,and follow up of inspections.The self-inspection report delivers to the senior management of company.Self inspection fndings are regarded as company privileged information,which is unavailable to read by inspectors of outside of the company.