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FDA Warning Letter on Significant Data Integrity Issues at Chinese Manufacturer

Data integrity issues continue to be a focus of FDA inspections. Significant problems with data proving the safety, efficacy and quality of manufactured medicinal products were among the reasons for the Warning Letter to the Chinese company BBC Group Limited.

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System Descriptions in GMP Inspections

As part of inspections the authorities also check computerised systems. Klaus Feuerhelm, former inspector at the Regierungspräsidium Tübingen, has created a TOP 3 list of the most frequent complaints for 2020. TOP 2 of the list - system descriptions. What were the deficiencies found here?

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Warning Letter regarding Insufficiencies Around Access Control

During an inspection the FDA found insufficiencies around access authorization. Read more about remediation activities required by the US FDA. 

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Audit Trail-Deviations in the course of Inspections

Computerised systems are also audited as part of inspections by the authorities. Klaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen, has compiled a TOP 3 list of the most frequent complaints for 2020 based on his inspections. TOP 1 on the list is the audit trail review. What deficiencies were found here?

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PIC/S publishes final Document on Data Integrity

The Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the international association of pharmaceutical inspectors, published the long-awaited guidance document on data integrity on July 1, 2021. Read more about the contents of the document PI 041 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

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Copies in the GMP Environment / True Copies

In the context of data integrity, copies and how to deal with them play a central role. How are copies defined, what do the regulations require and what does an inspector expect?

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ALCOA+ - what does it mean?

When we talk about data and data integrity, we always talk about ALCOA+. But what is hidden behind this abbreviation and do you really understand the implications?

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Data Integrity Issues at the Focus of a Warning Letter for a US-American Company

Data integrity issues remain at the focus of FDA inspections. Insufficient or missing controls to ensure the integrity of electronic test data were one of the reasons for the Warning Letter issued to the American company Stason Pharmaceuticals.

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Data Integrity - Do Data Flow Diagrams have to be available?

The topic data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 9: Must data flow diagrams be available?

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Audit Trail in the Centre of an FDA Warning Letter

The modification and deletion of electronic data must be documented by an audit trail. A missing audit trail led to a Warning Letter to the Indian company Shriram Institute for Industrial Research.

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