Drugs

Hanlim Pharm Co. CGMP Issues

A 4/16-4/24 FDA inspection at the Hanlim Pharm Co. drug manufacturing facility in Gyeonggi-do, South Korea, found violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/2 Warning Letter says the specific violations were:

failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failure to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups, and failure to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product; and
failure of the firm’s quality unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says significant FDA findings in the inspection demonstrate that Hanlim does not operate an effective quality system following CGMP. The agency acknowledges the firm’s commitment to suspend production of redacted drugs at the facility for the U.S. market and to cease production of all other redacted solutions. FDA is to be notified before Hanlim resumes any manufacturing operations.

FDA says it cited similar CGMP violations in a previous Warning Letter and the firm proposed specific remediations. “Repeated failures demonstrate that management oversight and control over the manufacture of drugs is inadequate,” it says.

The agency recommends that the company engage a qualified consultant to perform a comprehensive six-system audit of its entire operation, assist it in meeting CGMP requirements, and evaluate its corrective and preventive actions before it pursues resolution of its compliance status with FDA.

Hanlim was told to address the violations without delay and to ensure that sufficient resources are allocated to fully address the violations and prevent their recurrence.

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