Well-equipped Quality control laboratory

Separate areas for wet analysis, HPLC, GC, control samples, stability chambers, balance room, hot room, and microbiological analysis

Calibrated as per calibration calendar and maintained by AMC

Analysis of RM, PM, Intermediates. Finished Products and Stability samples

Monitoring of water system, clean rooms, and products as applicable

Preparation, review and approval of SOPs, protocols, and reports

Leading process validation, cleaning validation and analytical method transfers & process technology

The quality system is defined as per Schedule M, Schedule L, ICH Q7 and TRS guidelines

Issuance, retrieval, archival and control of documents

Release / Rejection of Raw materials and finished products

Qualification of vendors and contract laboratories

Self-inspection

Training and development of the staff

Trend analysis and annual product quality review

Investigating batch failures, deviations, and complaints. Ensuring GMP compliance of the facility