News

New Warning Letter of the FDA with the Focus on "Data Integrity"

The FDA has set the focus of its inspections on data integrity for quite some time already. The most recent Warning Letter addressed to a Chinese API manufacturer dated August 2016 clearly concentrates on the topic data integrity. Please find out more about the current FDA Warning Letter in this News.

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Two new FDA Warning Letters for API Manufacturers in China

In June 2016, two API manufacturers in China received a Warning Letter from the FDA. Both companies had major deficiencies regarding data integrity. For instance, manipulations were found in HPLC analyses as well as in GC analyses. You will find more information on the current FDA Warning Letters for Chongqing Lummy and Shanghai Desano here.

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Data Integrity - two new documents from PIC/S and EMA

Data Integrity is one of the hottest topics in regulatory activities at the moment. After the publication of draft documents by FDA in April 2016 and MHRA in July 2016, the PIC/S and the European Medicines Agency (EMA) followed on 10 August 2016 with two new documents. Please find here a short overview of the PIC/S draft PI 041-1 "Good practices for data management and integrity in regulated GMP/GDP environments" and the EMA  "Questions and Answers: Good Manufacturing Practices - Data Integrity".

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MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation

In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a "GMP Data Integrity Definitions and Guidance for Industry". The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation".

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German Company receives FDA Warning Letter for Data Integrity Issues

On 16 May 2016, the FDA issued a Warning Letter to the German APIs manufacturer BBT Biotech GmbH. Read more about the deviations discovered with regard to computerised systems and data integrity.

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Final WHO Guidance Document on Good Data and Record Management Practices

The WHO has just released the  the final version of the important guideline "Good Data and Record Management Practices".

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FDA Warning Letter calls explicitly for CAPA

The US FDA has published a Warning Letter that clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA).

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New FDA Draft Guidance 'Data Integrity and Compliance with cGMP' published

In the last years, the topic "data integrity" has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the topic which presents the comprehensive opinion of the FDA on data integrity. Read more about the draft of the Guidance for Industry "Data Integrity and Compliance with cGMP".

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European Non-Compliance Report on Data Integrity

The British authority MHRA has observed serious violations of data integrity at the Indian manufacturer Marksans Pharma Limited. Read more about the deviations with regard to data integrity.

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New FDA Warning Letter for Ipca Laboratories in India

In January 2016, a medicinal product and API manufacturer in India received a Warning Letter from the FDA. Manipulations of both the GC and the HPLC analysis were discovered during the review of the audit trails. Find out more about the current Ipca Laboratories FDA Warning Letter.

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