中英文版GMP自检规程.doc

本程序适用于所有。 This Self Inspection program applies to all GMP related activities performed in Gold Pharma. 责任人RESONSIBILITIES 自检计划的组织是质量保证部门的职责 Organization of the Self inspection program is under the responsibility of Quality Assurance.所有部门成员应当积极参与到自检程序中，以判定和纠正违反GMP规则的情况。 All the Departments should actively participate in the Self inspection program in order to help identify and correct non compliance situations. Annual Self Inspection Program QA应当和各部门负责人一起协作认真执行年度自检计划。该计划一经订立总经理和质量经理就应当努力推动完成。 QA will coordinate the elaboration of an annual Self Inspection program together with the heads of the different departments. Once established the program should be approved by the General Manager and the Quality Manager. 该计划应当订立一个时间表，并应当包含与GMP相关之所有方面 The program should have a calendar and cover all the areas and activities covered by GMP’s. 所有领域每年应当检查不少于1次 All the areas should be inspected at least once per year. 自检小组Self Inspection teams QA应当组织自检小组，成员应当对所检领域和GMP原则有良好认知。 QA should organize inspection teams with people that have a good understanding of the areas being inspected and of GMP’s. 自检执行Inspection performance 计划前一周，应当联系所检领域负责人员，通知准备应检。 A week before the planned date, the responsible of the area to be inspected should be contacted to confirm the availability for inspection. 检查组首先巡视受检领域，并观察操作流程遵守GMP的水平。 The inspection team will start with a visit to the area in order to observe the level of compliance during routine operation. 对记录进行文件复核以了解其遵守GMP和其他主文件的程度 A document review will follow to check how records reflect compliance with SOP’s and other master documents. 应在30日之内当提供一份自检报告并由QA签署（收集所有检查组成员的观察报告），并送达受检区负责人。严重违反GMP的情况应当报告总经理。 No later than 30 days after the inspection date a Self Inspection report should be compiled and signed by QA (collecting observations from all the team members) and sent to the responsible of the inspected area. Significant violations of GMP’s should be brought to the attention of the General Manager. 自检不符合项分以下几类： Ob