German Regulators Cite Dr. Reddy’s for GMP Non-Compliance
German pharmaceutical regulators have issued a statement of noncompliance of good manufacturing practice (GMP) to Dr. Reddy’s Laboratories for its dosage-form manufacturing plant (Unit 2) in Bachupally, Hyderabad, India.
The company was cited for non-compliance in manufacturing for the following areas: non-sterile products (processing operations for several dosage forms [hard-shell capsules, tablets, and other coated tablets and granules]); primary packaging (hard-shell capsules, soft-shell capsules, tablets, and other non-sterile medicinal products [coated tablets and granules]); secondary packaging; and quality-control testing (microbiological/non-sterility and chemical/physical). The company was cited for critical deficiencies in the plant’s pharmaceutical quality system, deviation and out-of-specification management, and cleaning protocols.
The notice, which was issued in early August 2017, means that the company will not be able to supply product from the facility to the European Union until successful re-inspection of the plant, to be initiated by invitation from betapharm, Dr. Reddy’s Augsburg, Germany-based subsidiary.
The notice of non-compliance was made by the Government of Upper Bavaria––Central Authority for Supervision of Medicinal Products in Bavaria and posted on EudraGMDP, a database maintained by the European Medicines Agency of manufacturing, importation authorizations, and GMP certificates issued from European Economic Area (EEA) countries. The EEA is composed of the European Union member states and Iceland, Liechtenstein, and Norway. The company also issued a notice through the Bombay Stock Exchange. An earlier notice was issued in April 2017 concerning products on the German market.
The manufacturing issues impacting supply of product to Europe follows recent manufacturing issues cited by the US Food and Drug Administration (FDA).
In May 2017, Dr. Reddy’s received a Form 483 with 11 observations from the FDA for its plant in Hyderabad following an FDA inspection completed in April 2017. Dr. Reddy’s noted that the observations were mostly procedural in nature and were related to the need to improve staff capabilities and strengthen documentation and laboratory systems.
That report follows earlier citations for other Dr. Reddy’s facilities in India in recent months. In April 2017, the FDA issued a Form 483 with two observations on the company’s active pharmaceutical ingredient manufacturing plant in Srikakulam, Andhra Pradesh, India. In March 2017, the agency issued a Form 483 with 13 observations for Dr. Reddy’s formulation manufacturing facility in Duvvada, Visakhapatnam, India.
The Duvvada facility was among three Dr. Reddy’s facilities that were named in an FDA Warning Letter received by the company in November 2015. In that Warning Letter, the FDA inspected three of Dr. Reddy’s Indian facilities in Ranasthalam, Srikakulam District from November 17 to 21, 2014; Tripuraram, Nalgonda District from January 26 to 31, 2015, and Duvvada from February 26 to March 6, 2015. The FDA identified cGMP deviations for the manufacture of active pharmaceutical ingredients at the Ranasthalam and Tripuraram facilities and found violations of cGMP regulations for finished pharmaceuticals at the Duvvada facility.