Posted 10 August 2017
By Zachary Brennan
Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.
The non-compliance report calls out the site, which manufactures and packages non-sterile capsules and tablets, for one critical deficiency related to the essential elements of its pharmaceutical quality system.
Out of specification (OOS) results “are systematically invalidated in hundreds of cases without traceable and scientific based root-cause-analysis due to 'staff-errors,'" the statement says. “Deviation- and OOS-management, but also protocol-, review- and reporting-systems are designed and executed in a way to systematically not document and report 'discrepancies, non-conformances, incidents, unusual events.'"
The regulators also call for the site to not supply product to the EU until there is a successful re-inspection.
The non-compliance statement also notes several major deficiencies related to deviation management, the design, condition and maintenance of rooms and equipment and the validation of manufacturing processes.
The US Food and Drug Administration (FDA) in November 2015 sent a warning letter to three Dr. Reddy's Laboratories sites also located just outside of Hyderabad.