Aurobindo in trouble for deviations from CGMP

Hyderabad: The US Food and Drug Administration (FDA) has pulled up city-based pharma major Aurobindo Pharma for 'repeated' violations in current good manufacturing practice (CGMP) at three of its plants in manufacturing certain active pharmaceutical ingredients (API) and intermediates.

The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API.

"The FDA cited similar CGMP observations at other facilities in your company's network. Aurobindo Unit I and Aurobindo Unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of (b)(4) API and intermediates.

These facilities are also considered to be in an unacceptable state of compliance with regards to CGMP. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate," said the FDA letter.

The repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate, the regulator said. In the letter issued on June 20 for unit XI which was inspected between February 4 and 9 the FDA said the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP and the API are adulterated within the meaning of US laws.

The FDA directed the firm, among others, to provide a comprehensive assessment of the state of maintenance of all equipment that can be used in the manufacture of drugs for the United States.

The letter also asked the company to identify corrective actions to ensure adequate quality oversight of operations for contract manufacturers performing functions that could affect drug quality, including any revised qualification and evaluation procedures.

"Provide an update on investigations and corrective action and preventive action (CAPA) plans initiated to address the presence of (b)(4) and other potential (b)(4) impurities in all API manufactured at the firm. Provide test results for all (b)(4) and intermediates for the presence of (b)(4), and other potentially(b)(4) impurities.

Conduct a retrospective review of (b)(4) batches for identification of (b)(4) impurities in chromatograms. Provide corrective actions for identifying unknown peaks in chromatograms using a properly validated method for (b)(4) impurities. Submit risk assessments for all API and intermediates manufactured at your facility for the potential presence of mutagenic impurities," it said.

Aurobindo had earlier said it believes the existing business from unit XI facility would not be impacted after receiving the warning letter for it. "We will be engaging with the regulator and are fully-committed to resolving this issue at the earliest,'' Aurobindo said. The company is also committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the company added.