ARTICLE · 1226803
FDA 483:使用未验证不受控的Excel表格进行QC数据计算
发布时间：2026-10-22 08:48:14 最近访问：2026-10-22 08:48:00
FDA 483:使用未验证不受控的Excel表格进行QC数据计算
公司名称: Novel Laboratories, Inc. d.b.a. Lupin (FEI No.：3006271438)地址：400 Campus Drive, Somerset, NJ 08873-1145, USA企业类型：Drug Manufacturer（药品生产企业，非无菌制剂）FDA发现实验室大量关键质量计算均通过Excel电子表格完成，但这些电子表格未经过验证。涉及到的excel表格的具体用途包括：系统适用性结果计算、含量结果计算、溶出度结果计算、含量均匀度计算、杂质计算等。这些电子表格用于GMP用途，但企业没有对表格进行编号以及版本管理、访问的权限控制、审计追踪和电子签名控制。没有证据对excel表格进行了验证，也没有第二人或者QA对表格中的数据进行审核。实际上受检企业的SOP实际上已经明确规定：所有Excel计算模板在使用前必须经过验证；同时Data Integrity程序规定：所有电子记录中的公式必须经过验证；所有计算结果必须经过确认。所以该条发现项表明除了不能满足GMP要求之外，企业也未遵守自身程序要求。OBSERVATION 3
The responsibilities and procedures applicable to the quality control unit are not fully followed.Excel spreadsheets used to perform GMP calculations, including system suitability assessments and analytical result calculations for HPLC analyses, were observed to be unvalidated and executed outside of your validated (b)(4) system. Specifically, the following spreadsheets were observed in use:These spreadsheets were observed to lack the identification numbering convention ((b)(4)), version control, cell protection, audit trail functionality, and electronic signature controls required by your own procedures. No evidence was observed that these spreadsheets were imported into or executed within the (b)(4) validated environment. No evidence of a second-person review or QA data reviewer sign-off was observed for the data contained within these spreadsheets.Applicable Firm Procedures:
• SOP NL-VA-007.3, Preparation, Protection, and Qualification of Excel Calculation Sheets, Section 6.4.2:"Users must use validated excel templates from (b)(4) only. System will not record audit trails if they are executed outside (b)(4)."
• SOP NL-VA-007.3, Section 6.1.2:Requires assignment of a unique identification number ((b)(4)) to all GMP Excel calculation sheets.
• SOP NL-IT-011.0, Data Integrity, Section 7.10:"All the electronic recording documents including excel spread sheets along with the formulas shall be validated and any changes thereafter shall follow change management process."
• SOP NL-QA-075.0, Review of Laboratory Documentation, Section 6.3.1.7:"When using Microsoft Excel spreadsheets for calculations, data reviewers must verify all the entries and calculations manually if Excel spreadsheet validation is not performed. If the Excel spreadsheet is validated, all the input entries and one model calculation must be verified."
基于该发现项的个人学习与拓展：
对于HPLC分析结果的计算，通常有两种方式：
1.使用Empower系统进行计算
Empower具备内置计算功能，可在系统内配置客户定制化的计算公式。色谱积分完成后，称量数据/对照品纯度等原始数据信息导入/输入到Empower系统，自动执行结果计算并生成分析报告。对于GMP相关计算，计算逻辑应在验证状态下进行管理，并纳入变更控制。
2. 使用电子表格（Excel）进行计算
对于重复使用的GMP计算模板，建议按照EDQM关于Excel Spreadsheet验证的指南完成验证，并建立相应的版本控制、权限管理、单元格保护和变更控制机制。对于一次性或临时使用的未验证电子表格，应实施适当的补偿性控制措施，包括：逐项核查原始数据输入、核查所有计算公式的正确性、由第二人实施独立计算确认并对审核结果签字确认。
感谢芳芳老师对这个问题的指点。如果你有关于实验室用excel表格管理和验证的更好做法或建议，请与我分享：一起交流、共同进步。 
