Regulatory Roundup: FDA Issues Warning Letter to Dr. Reddy's Following Inspection of the Company's Mexico-Based API Manufacturing Plant

The International Conference on Harmonization (ICH) steering committee and working groups met in Cincinnati, Ohio, June 11-16, 2011. As anticipated, the Q11 draft guideline on the development and manufacture of drug substances moved to Step 2 (six-party consensus) of the harmonization process based on its concept paper. The Quality Implementation Working Group, which focuses on the Q8, Q9, and Q10 guidelines, completed documents for publication on Criticality of Quality Attributes and Process Parameters, Control Strategy, and Level of Documentation in Enhanced (QbD) Regulatory Submissions. These documents will serve to provide supplementary information to the previously completed Q&A’s and training materials, according to the ICH release. With regard to global cooperation, non-ICH regulators from China, Chinese Taipei, Korea, and Singapore were nominated during the meeting to serve as expert representatives on some of the organization’s expert working groups. In addition, the East African Community, which includes Kenya, Uganda, Tanzania, Rwanda, and Burundi, joined in the Global Cooperation Group’s (GCC) membership. GCC is the body of ICH that works with non-ICH members to coordinate and harmonize standards. In other scientific news, a group of global regulators working in the area of cell therapy updated the ICH Steering Committee on their activities and “reported that they are exploring potential areas for future harmonization or other approaches to regulatory convergence,” according to the press release on the meeting. The next ICH meeting will be held in Sevilla, Spain, Nov. 5–10, 2011. Look for a full summary from ICH representatives in the August issue of PharmTech.

FDA issued Dr. Reddy’s Laboratories in Hyderabad, India, a Warning Letter earlier this month based on a November 2010 inspection of its API manufacturing plant in Morelos, Mexico. The Warning Letter, noted that the inspector found significant cGMP deviations that, under the Federal Food, Drug, and Cosmetic Act, are considered to be product adulteration, and that Dr. Reddy’s Dec. 1, 2010, response letter did not adequately address the corrective actions required. Deviations included validation of analytical methods used to test APIs, incomplete cleaning validation of nondedicated manufacturing equipment, a lack of full investigations for out-of-specification data, and irresponsibility in ensuring cGMP compliance with API manufacture. Dr. Reddy’s was given 15 working days to reply to FDA about the steps it has taken to correct in full these deviations.