Quality Control

Adequately designed QC for testing of in process, raw material, packaging material, finished product and stability testing of product

Our Quality control lab is designed as per USFDA requirements and encompasses approximately 200m 2 area, separate rooms, and dedicated areas for special activities like TOC room for TOC analyzer, GC room for Gas Chromatography system, weighing room for weighing balances, stability room for stability chambers and incubator room for incubators and ovens are provided. Separate area for glass ware cleaning is provided and supplied with soft water, purified water user point is provided in area for reagent preparation glassware rinsing.

All the chemical testing is performed in chemical lab and instruments like UV-VIS spectrophotometer, HPLC are installed in Instrument lab which are used in in-process, finished product testing and stability testing.

Hot room area is specially designed for activities for instruments which generate heat like, water bath, muffle furnace, heating plate, vacuum oven, and fume hood.

Lab support area is provided for document storage, analyst/technician seating. QC area is equipped with fire sensor, safety shower (QC Corridor), eye washer placed in chemical lab wash area and hot room.

Documented procedures are in place describing sampling, testing, approval, or rejection of materials and recording and storage of laboratory data.

Specifications, sampling plans, and test procedures, including changes to them are prepared by the appropriate QC personnel, reviewed, and approve by Quality Assurance through change control process.

Stability chambers and incubators are controlled and monitored through ICDAS software. Quality control analysis and records are well monitored and controlled through ERP software and archived into a dedicated server.

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