FDA inspection uncovers “a cascade of failure” at Ipca Laboratories in India
It has been over four years since the FDA banned the entry of finished drug products made by Ipca Laboratories in India. From a recent Form 483 issued to the India drugmaker, it seems like Ipca has a long way to go before the FDA is convinced that it meets its quality standards.
The warning letter issued to the finished drug manufacturing site located at Silvasa in January 2016 highlights that during the FDA inspection, the investigators found data-integrity issues in the Quality Control Lab.
Following an inspection of the same site from August 19 to 23, 2019, the FDA issued Ipca a Form 483, which reveals that the agency continues to have a lot of questions for the Indian drugmaker to answer on its approach to quality.
During the inspection, the FDA investigators observed “a cascade of failure” in its quality unit. And these failures pertain to “controls on issuance of GMP forms, review of laboratory testing data, conducting investigations” and conducting activities as per the written procedures.
The FDA investigators found that the Indian drugmaker had changed the computer system setting of its chromatography software to use the “inhibit integration” function which allowed it to calculate results based on “only select peaks of interest” and avoid integration of unknown peaks. Unknown peaks could represent impurities that were being excluded from the analysis and may have impacted the final decisions.
In another instance, quality control (QC) analysts were found to deviate from standard testing procedures for over 12 years while conducting dissolution tests and for more than over two years while conducting assay and related substances by HPLC (high performance liquid chromatography) tests.
The FDA also raised concerns after uncovering significant gaps in Ipca’s data integrity procedures with respect to handling of its electronic raw data.
Ipca also failed to investigate complaints in a timely manner as a complaint where “hair was found embedded in the tablet” was open for over five months. The absence of established timeline was also found to apply to changes and corrective actions as some changes had been open for almost three years.