News

New FDA Draft Guidance 'Data Integrity and Compliance with cGMP' published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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Current FDA Warning Letter for Manufacturer Cadila in India

As part of its inspections, the FDA nowadays always examines the integrity of data. This can clearly be seen in the recent Warning Letter from December 2015. Besides, the letter focuses on the inappropriate handling of OOS results. Read more about the current FDA Warning Letter on Data Integrity. 

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ECA establishes new Interest Group on Pharmaceutical IT Compliance

The ECA Foundation has established various working and interest groups concentrating on different topics. To cover IT technologies with regard to international GMP requirements the Foundation now established a new Interest Group on Pharmaceutical IT Compliance.

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New WHO Draft on "Good Data and Record Management"

Data Integrity as a topic has become one of the main focuses of the regulatory authorities. Mid-September, the WHO published a draft guidance for comment on this topic too. Read more about the WHO Draft Guidance on Good Data and Record Management.

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Consequences of the new MHRA Guideline for Excel

In March 2015, the British authority MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). These requirements apply to all electronically stored data - regardless of the technology used for data saved in MS Excel. Learn more about the relevance of the MHRA Guideline for MS Excel.

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Another FDA Warning Letter with Focus on "Data Integrity"

The US FDA has a new focus of their inspections: the review to the integrity of data. A recent Warning Letter from July 2015 shows again a clear focus on the issue of data integrity. Please find more information in the Current FDA Warning Letter regarding Data Integrity.

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The integrity of GMP data - part 2 of the new MHRA blog

In July 2015, the second MHRA blog on the theme of data integrity went live. This time, the focus is on designing systems properly. The ALCOA principles are considered to be very helpful. Read more about the MHRA Good Manufacturing Practice (GMP) Data Integrity blog part 2.

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Integrity of GMP Data - New MHRA Blog!

In June 2015 the MHRA, UK, has started an online blog particularly on data integrity. From their perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. Read more about the MHRA Blog on Data Integrity.

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