FDA原料药检查六个系统的内容.doc

APPENDIX A: Description of Each System and Areas of Coverage 附件A：系统的描述与包含的内容 QUALITY SYSTEM 质量系统： Assessment of the Quality System has two phases. The first phase is to evaluate whether the Quality Unit has fulfilled the responsibility to review and approve all procedures related to production, quality control, and quality assurance and assure the procedures are adequate for their intended use. This also includes the associated recordkeeping systems. The second phase is to assess the data collected to identify quality problems and may link to other major systems for inspectional coverage. 质量系统的评价有两个方面。第一个方面是评价质量部门是否已经履行职责，审核批准所有与生产，质量控制和质量保证有关的程序，并确保有足够的程序来保证运行。这也包括相关的记录保存系统。第二个方面是评价收集到的数据资料来确定质量问题，可能相关的其他主要系统也在检查范围内。 For each of the following bulleted items, the firm should have written and approved procedures and documentation resulting therefrom. The firm’s adherence to written procedures should be verified through observation whenever possible. These areas are not limited to the final API’s, but may also include starting materials and intermediates. These areas may indicate deficiencies not only in this system but also in other systems that would warrant expansion of coverage. All areas under this system should be covered; however the actual depth of coverage may vary from the planned inspection strategy depending upon inspectional findings. 对下面所列的条款，公司应该有书面的经过批准的程序和文件记录。公司是否遵循书面程序应该通过观察来证明。这些内容不局限于API，也适用于起始物料和中间体。这些内容阐明的不仅仅是本系统的不足，也说明了其他系统存在的缺陷，这就需要扩大检查内容。本系统的所有方面都应该包括在内，但实际包含的范围可能与计划中的检查内容有所改变。 ? Adequacy of staffing to ensure fulfillment of quality unit duties 有足够的人员来确保履行质量部门的职责。 ? Periodic quality reviews as described in ICH Q7A Section 2.5, Product Quality Review; inspection audit coverage should include API types that are representative of manufacturing at this site; inspection audit should also examine some batch and data records associated with each API quality review to verify that firm’s review was sufficiently complete; and, audit should confirm