Drugs

CGMP Deviations at Lijiang Yinghua Biochemical

A 10/16-10/20/17 FDA inspection at Lijiang Yinghua Biochemical and Pharmaceutical Co., Lijiang, Yunnan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 4/19 Warning Letter said the deviations were:

failing to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data;
failing to maintain complete data derived from all laboratory tests conducted to ensure that the API and intermediates comply with established specifications and standards;
failing to document, explain, and investigate any deviation from established procedures; and
failure of the quality unit to review and approve all appropriate quality-related documents.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” FDA tells the company. It recommends the company engage a qualified consultant and asks for (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a management strategy for the firm that includes details of its global corrective action and preventive action plan.

Numerous similar CGMP violations were cited in a 2015 FDA inspection, the letter says. The current inspection identified multiple failures to implement specific corrective actions the firm proposed at that time. “These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drug products is inadequate,” FDA says. “Explain how you intend to assure your commitments are fulfilled and corrective actions are completed.”

The agency placed the company on an import alert 2/8. Linjiang was told the respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome