Quality Management
Company contributes to pharmaceutical industry through continuous research and development based on the feedback from the customers, ensuring the delivery of highest quality drug substances with zero tolerance.
Quality Management System is in compliance with Acts and Rules of:
- Schedule M
- ICH Q 7
- 21CFR Part 210 & 211
- ISO 9001
Facilities/Quality Control Laboratory
Well-equipped in-house quality control lab consisting of facilities for wet, instrumental and microbiological analysis along with facility for stability studies.
For chemical and instrumental analysis
Apart from wet analysis facilities, laboratory is equipped with major instruments like HPLC, TLC kit , Karl Fisher Titrator , Abel Heat Stability Tester
For Microbiological Analysis
Major facilities of:
- Double door autoclave
- Automatic Temperature controlled BOD Incubators
- Laminar Workstation
- Pass box
Monitoring & Controls
Environmental monitoring
Water quality monitoring
Incoming material control
In-Process control
Change control system
Personnel monitoring
Access control in buildings
Qualification & Validation
Qualification
Manufacturing Equipment / Instruments /Machines, Utilities and QC measuring equipment / instruments qualified for Design, Installation, Operation and Performance as per laid down Quality Management System.
Validation
All manufacturing process are duly validated by the system of
All in house developed analytical methods are validated and analytical methods adopted from pharmacopeia are verified as per pre-approved validation/verification protocols.
