European Non-Compliance Report on Data Integrity

Recommendation

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Berlin, Germany

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The results of inspections performed by the European authorities are published in the EudraGMDP database. Negative results can be found in the "Non-Compliance Reports" area - see our News "Already 13 EMA GMP Non-compliance Reports in 2016 published".

On 17 March.2016, the British authority MHRA published a Non Compliance Report against the Indian company Marksans Pharma Limited. The report lists serious problems with regard to data integrity.

A number of serious violations of the pharmaceutical quality system had already been observed during a first inspection performed in March 2015. These violations related to the systems assuring data integrity, deviation and CAPA management, change control, PQRs and self-inspections. During a re-inspection in November 2015, the inspector noticed that many of the violations observed hadn't been processed. Among other things, the critical violations with regard to the systems assuring data integrity were still present:

• Evidence of destruction of multiple parts of records of prime data
• Overall Data Integrity management and oversight
• Investigations into Missing and deleted data within laboratory incomplete
• Procedures controlling Data Integrity within the laboratory not in place

As a consequence for the company, comprehensive measures have been imposed until the Non Compliance Report is worked out:

• Withdrawal of previous GMP Certificate No. ...
• No further marketing authorisation(s) should be approved naming the site as manufacturer
• No further batches of medicinal products considered non-critical to public health to be supplied to the market whilst this statement of non-compliance remains in force

Source: Overview of all EudraGMDP non compliance reports