There must be document controls in place to assure product quality (see §§ 211.100, 211.160(a), 211.186, 212.20(d), and 212.60(g)). For example, bound paginated notebooks, stamped for official use by a document control group, provide good document control because they allow easy detection of unofficial notebooks as well as any gaps in notebook pages. If used, blank forms (e.g., electronic worksheets, laboratory notebooks, and MPCRs) should be controlled by the quality unit or by another document control method. As appropriate, numbered sets of blank forms may be issued and should be reconciled upon completion of all issued forms. Incomplete or erroneous forms should be kept as part of the permanent record along with written justification for their replacement (see, e.g., §§ 211.192, 211.194, 212.50(a), and

212.70(f)(1)(vi)). All data required to recreate a CGMP activity should be maintained as part of the complete record.

必须有文件控制以确保产品质量（见§§ 211.100，211.160(a)，211.186，212.20(d)和212.60(g)）。例如，装订有页码的记录本，由文件控制小组盖章才可正式使用，提供了良好的文档控制，因为它们可以方便地检测非正式的记录本以及记录本中的任何缺页。FDA建议，如果使用的话，空白表格（如记录表电子版、实验室记录本和MPCR）应由质量部门或由其它文件控制方法控制。可酌情发放编好号的一套空白表格，并在完成后对所有已发放的表格进行核对。不完整或错误的表格应作为永久记录的一部分留存，并附有更换这些表格的书面说明（例如，见§§ 211.192，211.194，212.50(a)和212.70(f)(1)(vi)）。用以重建CGMP活动所需的所有数据都应作为完整记录的一部分加以保存。