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【PIC/S】Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

【PIC/S】Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

发布时间:2016-08-10 浏览量:597


Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

August 2016


Geneva, 10 August 2016: PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised data integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures – including a stakeholders’ consultation - on a revised version after completion of the trial-period.

To download the draft guidance (PI 041-1 (Draft 2)), please consult the page “Publications” or click on the link below:

PI 041-1 (Draft 2) Guidance on Data Integrity.pdf


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