Drugs

CGMP Violations at PT MegaSurya Mas

An 11/11-11/15/19 FDA inspection at the PT MegaSurya Mas drug manufacturing facility in Sidoarjo, Jawa Timur, (East Java, Indonesia) found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/24 Warning Letter says specific violations were:

failing to have, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release, and failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods;
failing to conduct at least one test to verify the identity of each component if a drug product and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failing to follow written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter recommends that the firm retain a qualified consultant to assist it in data integrity remediation. It was told to provide (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the drugs produced, and (3) a management strategy that includes details of a global corrective and preventive action plan.

PT MegaSurya Mas was placed on an import alert on 6/18. It was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, including a schedule for completing the steps.

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