The agency sent a warning letter to the Indian company after an inspection revealed violations of the CGMP, including a lack of written procedures and analytical testing.
The FDA sent a warning letter to Wilson Medicine Company, as of September 11, 2018, after inspectors discovered violations of current good manufacturing practices at the company’s plant in Nandore, Palghar East, Thane, India. During the inspection, which took place from February 26 to March 1, 2018, inspectors observed a lack of written procedures for drug quality testing and equipment cleaning.
More specifically, the company did not perform process performance qualification and did not demonstrate that its processes were reproducible and controlled. Equipment qualification had not been carried out either.
According to the FDA, analytical test methods, including dosage, non-volatile residue limit, preservative limit, and specific gravity, have not been validated. “Although you have committed to preparing an analytical method validation protocol by May 20, 2018, you have not specified a timeframe to complete method validation / verification or provide a provisional action plan. “the agency said. The agency asked the company to provide an independent assessment of all test methods, an action plan to complete validation of analytical test methods, a review of its entire laboratory system, and a summary of the results. test results obtained from the tests to retain samples of all pharmaceuticals. in the expiration.
The FDA has also requested an update on the company’s cleaning validation protocols for all manufacturing equipment. The company must also provide a risk assessment of the effect of its inadequate cleaning practices on product quality, an action plan to ensure adequate cleaning and an independent review of its facility to assess potential risks of contamination. cross.