News

How important is "Data Governance" for your Company?

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.

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Is Senior Management really responsible for GMP?

Yes, it is! As you can see in a recent case from Denmark, where the Danish Medicines Agency requires that the CEO of a repackaging facility needs to be replaced.

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New FDA Warning Letter for Wockhardt, Ltd. in India

The manufacturer of APIs and medicinal products Wockhardt in India received an FDA Warning Letter at the end of December 2016. During the inspection, it had been observed that both in GC and HPLC analytics OOS results were excluded from the official records. Get more information about the current Wockhardt FDA Warning Letter.

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GMP Update - what was new in 2016?

"You get the impression that GMP is developing faster and faster". During the past year, the world of GMP turned somewhat slower. Its developments in the GMP environment remain interesting though.

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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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