Quality Assurance
- Quality Management System (QMS)
- Validations & Qualifications
- Review of Batch Records, Analytical Data
- Batch Release
- Document Issuance & Control
- Annual Product Quality Review
- Deviation Management
- Change Control Management
- Out of Specification (OOS) & Failure Investigations
- Corrective and Preventive Actions
- Market Complaints
- Self Inspection
- Vendor Qualification Program
- Training Program
- Qualification of Equipment and Validations
- Quality Risk Management
Site Quality Control Functions
- Sampling, Testing & Release of Raw material
- In-process, Intermediates, Packing Materials
- Sampling & Testing of Finished Drug Substance –API’s.
- Analytical Method Transfer & Verification Activities.
- Stability Studies as per ICH guideline.
- Control Sample Management
- Calibration & Preventive Maintenance of Quality Control Instrument
- Qualification of Quality Control instrument.
- Water Analysis
- Microbial Analysis (Water & Environmental monitoring)
- Reference Standards / Working standards management
