Drugs

Taiwan Biotech CGMP Violations

A 9/1-9/11/17 FDA inspection at Taiwan Biotech Company, Taoyuan City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/31 Warning Letter. Specific violations cited in the letter were:

failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
· failing to follow an adequate written testing program designed to assess the stability characteristics of drug products; and
failing to maintain written records so that data therein could be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.

“Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and/or responsibilities,” the letter says. “Your firm must provide the quality unit with appropriate authority and sufficient resources and staff to carry out its responsibilities and consistently ensure drug quality.”

Because the quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of drugs the firm products, the company was told to submit (1) a comprehensive investigation into the extent of the inaccuracies in data records and reports with a detailed description of the scope and root causes of the data integrity lapses; (2) a current risk assessment of the potential effects of the observed failures on quality of the company’s drugs; and (3) a management strategy for the firm including details of its global corrective and preventive action plan.

FDA recommended that Taiwan Biotech retain a qualified consultant to assist it in meeting CGMP requirements. The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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