Torrent oral

Your b 4 water system was not adequately designed, controlled, maintained, and monitored to ensure it consistently produced water that met b 4 Water, b 4 specifications and appropriate microbial limits. Among the sanitary design deficiencies in the water system were multiple dead legs and threaded pipe connections.

Notably, your firm isolated Burkholderia cepacia from manufacturing equipment rinse samples. An investigation identified your water system as the source of the contamination. Subsequent sampling of your water system revealed an adverse pattern of B. Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes.

Systems that produce water for manufacturing and cleaning are critical determinants of the quality and safety of your drug products. Your firm produced drug products such as rectal suppositories and oral solutions with this inadequate b 4 water system.

Until recently, you also produced nasal solutions with this system. Your response stated that the design of the pipes and fittings, along with multiple deadlegs, contributed to the b 4 water system contamination. We acknowledge that you decided to decommission and replace the water system.

However, in your response, you proposed to procure and use a temporary system until you install a permanent replacement system. Your response lacked sufficient interim measures to ensure the water generated from your temporary system meets appropriate quality standards for b 4 water. Your response also lacked sufficient detail about the design of the temporary and new water systems, and your plan to properly monitor and maintain each system.

Regarding the latter, ensure that the total count limit for your b 4 water is appropriately stringent in view of the intended use of each of the products produced by your firm. Include the system validation protocol, the complete test results, and the final validation report. Denote whether the products are aqueous or non-aqueous formulations. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed 21 CFR You lacked an adequate investigation into failing microbiological results from your b 4 water system.

A significant trend of microbiological deviations in the system emerged after you adjusted your sampling and testing procedures in December to be more capable of detecting B. You did not sufficiently extend the investigation to potentially affected marketed batches until months after you detected the adverse pattern of objectionable microbial contamination, and several weeks after our inspection.

The initial investigation also did not adequately address the significance of water system design deficiencies. Your response stated that you ceased using your current b 4 water system and recalled all batches of drug product currently on the market. We acknowledge your market actions and corrective action commitments.

However, your response is inadequate because it lacked sufficient assurance that your system for investigations will be remediated to ensure timely, thorough, and effective investigations.

Your CAPA plan should include, but not be limited to, significant improvements in investigation competencies, root cause evaluation, scope determination, quality unit oversight, and written procedures.

It should also address how you will ensure that all phases of investigations are appropriately conducted and that the CAPA is effective. In response to this letter, provide b 4. We request that you notify this office b 4. June 29th, India. May 18th, Ahmedabad India. Torrent Pharma announces Q4 FY21 results click here. May 13th, Ahmedabad India. February 8th, Ahmedabad India. Torrent Pharma announces Q3 FY21 results click here.

Torrent Pharma announces Q2 FY21 results click here. July 30th, Ahmedabad India. Torrent Pharma announces Q1 FY21 results click here.

August 30th, Ahmedabad India. Torrent Pharma announces Q4 FY20 results click here. Q3 FY Ahmedabad India. Jan 27th, July 11th, January 18th, Torrent Pharma acquires Bio-Pharm, Inc.

December 11th, India. November 3rd, India. Toggle navigation. Click here for more information. Environmentally Responsible Green Ambience.