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QA & QC Department

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QA & QC Department

Endoc Biotech has buildup ultra modern, fully equipped quality control lab managed by well experienced and qualified staff.QA/QC block is equipped with Wet Labs, Common Instrumentation Labs, separate HPLC, GC, Stability, chemical storage, retain sample, Melting point Apparatus, Polarimeter, Hot room and separate Microbiology Labs to carry intermediate, in-process, and final product analysis.

The instrumentation includes HPLC with RI, UV, DAD detector, GC with Headspace, UV, FTIR, Osmometer, and all other instruments required to analyse products as per current USP/BP.

Endoc Biotech having in-house stability study facility with 4 different zone stability chambers and 2 cold chamber.

Well equipped Microbiology Lab with Air Sampler, Clean Room Validation Equipment, BOD incubators Autoclave etc to perform the BET and Microbial Limit Test (MLT).

QA and Regulatory Affairs team works according to ICH guidelines. Capital latters and team engaged in all areas of cGMP implementation, Validations, Audits Compliance & Response, DMF preparation & submission, updation to regulatory agencies and customers in Emerging as well as Regulated markets.

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