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Non-compliance report issued to Marksans Pharma Limited on account of GMP violations by MHRA(Medicines & Healthcare productsRegulatory Agency)

The British authority MHRA (Medicines & Healthcare products Regulatory Agency)had published a Non Compliance Report against the Indian company Marksans Pharma Limited on account of data integrity issues.

The first inspection of the company was performed in March 2015 wherein a number of serious violations of the pharmaceutical quality system had already been observed such as violations related to the systems assuring data integrity, deviation and CAPA management, change control, PQRs and self-inspections. Re-inspection was performed in in November 2015 in which the inspector noticed that many of the violations observed were not taken into account. The critical violations with regard to the systems assuring data integrity were still present as mentioned below:

• 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 such as
• 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



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