Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. You also failed to provide adequate justification in your process validation protocols to support approval of the alternate API with known PV failures. You failed to provide adequate root cause for the initial PV batches failures. You also stated the change in API had no impact on the manufacturing process and the quality of the finished drug. Your response acknowledged that you did not follow your written and approved validation protocols. In addition, multiple batches of Losartan Potassium were recalled for unacceptable amounts of nitrosamine impurities. Numerous Losartan Potassium Tablets USP 50 mg and USP 100 mg commercial batches were manufactured with this new alternate API and released to the U.S. You developed a new interim protocol to justify commercial use of the alternate API and circumvented your original protocol, even though you had data demonstrating your process was not capable of producing quality material using the new alternate API. Multiple out-of-specification (OOS) investigations were initiated and quality rejected all four PV batches. However, the fourth batch also failed specifications for dissolution. Specifically, after the first of the three PV batches failed for dissolution, assay, and (b)(4), your firm added a fourth batch which was outside of your written protocol. Several PV batches using a new alternate API were manufactured for Losartan Potassium Tablets USP 50 mg and USP 100 mg without appropriately following your protocol. Your firm did not appropriately follow your written and approved process validation (PV) protocol which required quality attributes to be met for “three consecutive” batches to qualify an alternate active pharmaceutical ingredient (API). Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(b)). We reviewed your May 7, 2019, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.ĭuring our inspection, our investigators observed specific violations and deviations including, but not limited to, the following.ġ. See 21 CFR, parts 210 and 211.īecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Torrent Pharmaceuticals Limited, FEI 3005029956, at Ahmedabad-Mehsana Highway, Taluka-Kadi, Indrad, Gujarat from April 8 to 16, 2019. Max.Issuing Office: Center for Drug Evaluation and Research ![]() Material: 840 D Oxford nylon, TPU film laminate Oeko-Tex 100 ![]() Laptop compatible neoprene inner compartment Contact pad back with height-adjustable chest strap Practical: the bracket for attaching the flashing light. Thanks to its slim and compact shape, the Torrent 20 sits comfortably on your back even on bike tours and cuts a fine figure when climbing on multi-pitch tours. The carrying system with contact pad back, contoured straps, chest and hip belt offers good carrying comfort and is sometimes looseĪ longer day hike away. Which holds all kinds of electronic gadgets up to 15 "notebooks securely padded. The interior consists of an elastic neoprene pocket (34 x 25 x 3 cm), Thanks to the roll closure and high-frequency welded design in top quality, the contents remain dry in all weathers - be it a downpour or continuous rain. The Exped Torrent 20l is an easy-care everyday companion, which, thanks to its simple handling and purist equipment, is ideal for driving to school, work and the weekly market.
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