关于data integrity在委托实验室和校验单位的管理

beiwei5du

各位蒲友：


在中国CFDA最近公布的《药品数据管理规范》（征求意见稿）中均有提到相应的委托（外包）工作的范畴：
第二条【范围】本规范适用于药品研制、生产、流通等活动，包括从事上述活动的临床试验、合同研究（CRO）、委托生产（CMO）、委托检验等单位和个人。（没有包括委托校准和委托IT数据管理）
WHO good data and record management中也提及到：
The organization outsourcing work has responsibility for the integrity of all results reported, including those furnished by any subcontracting organization or service provider. These responsibilities extend to any providers of relevant computing services, such as contracted IT data centres, contracted IT system and database support personnel and cloud computing solution providers.

及其他一些课件（爱尔兰HPRA）：data integrity: a regulator' perspective http://www.it-asso.com/gxp/files/HPRA_DataInteg_150512.pdf
Inspection focus
•EU Regulatory Requirements – Part I Chapter 4 and Annex 11 and Part II
•Data integrity requirements applicable to:
–API and FP manufacturers, including contract manufacturing
–Testing units, including contract laboratories
–Outsourced GMP activities such as equipment qualification and calibration

那么对于委托检验和委外校验的监管的数据完整性也是需要极其重视的一个方面，这方面国家没有重视起来，配套机构的数据完整性还是很关键的。

beiwei5du

现在很多公司在委托实验室和委托校验的时候，仅仅出具相应的检测报告和校准报告是不合适的，下文有谈到summary report的局限的问题（这个也即是我们的检测报告和校准报告的缺陷）8.12 Limitations of remote review of summary reports
8.12.1 The remote review of data within summary reports is a common necessity; however, the limitations of remote data review must be fully understood to enable adequate control of data integrity.
8.12.2 Summary reports of data are often supplied between physically remote manufacturing sites, Market Authorisation Holders and other interested parties.However, it must be acknowledged that summary reports are essentially limited in their nature, in that critical supporting data and metadata is often not included and therefore original data cannot be reviewed.
8.12.3 It is therefore essential that summary reports are viewed as but one element of the process for the transfer of data and that interested parties and inspectorates do not place sole reliance on summary report data.
8.12.4 Prior to acceptance of summary data, an evaluation of the supplier’s quality system and compliance with data integrity principles should be established through on-site inspection when considered important in the context of quality risk management. The inspection should ensure the veracity of data generated by the company, and include a review of the mechanisms used to generate and distribute summary data and reports.