新版gsp自查（New version of GSP self-examination）.docVIP

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新版gsp自查（New version of GSP self-examination）.doc

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新版gsp自查（New version of GSP self-examination）

新版gsp自查（New version of GSP self-examination） Quality management staff of 4 people, including quality management and quality management agency responsible for 1 people, quality administrator and inspector 1 people, 1 inspectors, maintenance personnel 1 people. Two, the GSP quality system, management responsibilities: 1 self summary enterprise establishes the main person in charge of quality led by the leadership of the organization, and clear its responsibilities: to establish the quality system of the enterprise, the implementation of enterprise quality policy, ensure the staff exercise the functions and powers of the enterprise quality management, supervision and implementation of the GSP implementation and carry out internal audit work GSP. The establishment of the quality management organization includes: quality management department head, quality administrator, inspector and maintenance staff. Quality management department in 2007 October on the enterprises pharmaceutical business quality management system was revised, approved by the enterprise legal person, further standardize the drug business activities. According to the provisions of GSP and the drug circulation supervision and management measures, and carry out the quality management department is responsible for the enterprise staff training, training includes the quality management of drug regulations, enterprise pharmaceutical quality management system etc, improve the quality of personnel, to carry out security quality management work. The quality management department for inspection, quality management system for the examination of the enterprises and the GSP internal audit plan, the annual regular inspection, assessment and evaluation, the continuity of effective operation of the protection of the quality system and quality management. 2, personnel and training, pharmaceutical technicians accounted for 30% of the total number of staff; tertiary education, secondary school education and high school e