Torrent Pharma is now red flagged by USFDA for significant violations of current good manufacturing practice (cGMP) regulations for its Indrad facility in Gujarat.
An inspection has been conducted by the United States Food and Drug Administration (USFDA) at the facility from April 8 to 16, 2019.
The issued warning letter by the regulator to Torrent Pharma constituted of observation regarding failure of documentation for production and controlled process designed for assurance regarding the drug products manufactured that have the identity, strength, quality, and purity they proclaimed to possess.
Company was asked by the regulator to submit a detailed summary of its validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures.
The firm was failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its constituents to meet any of its specifications.
Regulator acknowledged that the company has hired a consultant; hence, they asked the consultants to engage themselves in assisting the firm in meeting cGMP requirements.
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