FDA Warning Letter to Indian Manufacturer for Inadequate Testing of Incoming APIs

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

The U.S. Food and Drug Administration (FDA) has released a Warning Letter dated February 13, 2020 to India-based drugmaker JHS Svendgaard Hygiene Products Ltd. During an inspection from August 19 to 22, 2019, the FDA investigator observed specific violations of current good manufacturing practice (CGMP).

Inadequate testing of incoming APIs and inappropriate validation of analytical test methods

JHS Svendgaard Hygiene Products Ltd lacked adequate testing of the incoming active pharmaceutical ingredient (API) to determine assay and other appropriate quality attributes. Instead, the firm relied on "suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation."

Furthermore, the company lacked to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. In this context, the FDA notes: "Analytical methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. Verifying the accuracy, sensitivity, specificity, and reproducibility […]  is essential to determine if the drug products […] meet established specification for chemical and microbial attributes."

Inadequate process validation programme / Required supervision by quality assurance not guaranteed

Another point mentioned in the Warning Letter refers to the process validation programme. According to the FDA, the firm did not follow their SOPs for process validation and did not implement a programme that ensures an ongoing state of control throughout the lifecycle of drug products manufactured. The FDA highlights that "successful process qualification studies are necessary before commercial distribution."

Also, the quality unit's oversight of the drug manufacturing operations was considered inadequate: Deviations that could compromise the finished drug products were not investigated properly, and it was not ensured that representative batches produced were placed on the stability testing programme.

Based upon the nature of the violations identified, the FDA recommends engaging a consultant to assist the firm in meeting CGMP requirements.

The company has also been placed on Import Alert 66-40 on January 2, 2020. Until all violations are corrected completely, and compliance with CGMP is confirmed, the FDA may withhold approval of any new applications or supplements listing the company as a drug manufacturer.

Please also see the original FDA Warning Letter to JHS Svendgaard Hygiene Products Ltd.