Q. A. Group Responsibilities
- To design and approve specifications and test methods for Raw material, packaging material, finished product etc.
- Calibration of instrument.
- Need based procedural development.
- Executing validation.
Utilities
- Compressed Air
- D.G. Set
- Vacuum Pump
- E.T.P
- Source of Water Supply
- Telecommunication
Validation
- Water, AHU system validations.
- Process, Method, Cleaning, Personal, Premises and Equipment Validation adhering to GMP standards.
Salient features of Quality Control
- Well Equipped with modern state of the art instrument like HPLC, UV-VIS Spectrophotometer, FTIR etc. and Chemical Analysis Section.
- All the requisite sections include Analytical, Chemical, Instrumentation and Microbiological for complete In-house Testing.
- Separate Record Room.
- Well Defined Store for Glassware Chemicals.
- Dedicated Microbiology Section having separate AHU equipped with HEPA filtered (0.3 micron) air.
- Triple Air Lock for Microbiology with U.V. in Laminar air flow room.
- Restricted entry and Double Gowning Procedure in Micro testing room.
- Conference Room for Quality Control Quality Assurance Equipped with Audio Visual presentation.
- Highly Qualified and Experienced Staff.
Q. C. Group Responsibilities
- Training for QC, Production, Warehouse, Packing group supervisors and Workman for Non Specific and Generalized Training for GMP, Personal Hygiene etc.
- Conducting Internal and Vendor Audit.
- Monitoring cGMP compliance.
- Documentation Record Keeping.
- MFC & S.O.P Preparation.
- Programming Reviewing Stability Studies of Products.
- Upgrading Manufacturing Q.C. system.
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