1.Guidance forIndustry Investigating Out-of-Specification (OOS) Test Results forPharmaceutical Production 2006 2.https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/678256/MHRA_OOS_OOT_Oct17.pptx 3. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations...
11、ds of starting materials and in-process samples may also yield out of trend data. The result is not necessarily OOS but does not look like a typical data point. Atypical / Aberrant / Anomalous Result Results that are still within specification but are unexpected, questionable, irregular, ...
数据完整性定义与期望 March 2015 MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 MHRA GMP 数据完整性定义和行业指导原则 2015 年 3 月 简述 : Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This ...
Yes. Theanalytical requirements should be agreed with MHRA Clinical Trials via theclinical trial application (CTA). If an activity defined as manufacture takesplace (see above) then the resultant IMPs should be tested to confirm that thespecification submitted in the CTA is met. There may be exc...
背景介绍 Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry. This guidance is intended to complement existing EU GMP relating to...