Quality Management System
We provide technical guidance to design, prepare and implement Quality Management System of following industries as per US FDA, EU GMP, PIC/s, WHO, NSF & ISO Guidelines.
- Pharmaceutical Formulations/Drug Products Manufacturing Facility (Tablets, Capsules, Liquid Orals, Injections & Ointment)
- Food Products manufacturing facility
- Medical Devices Manufacturing facility
- API manufacturing facility (Sterile & Non-Sterile)
- Key Starting Material and Intermediate Manufacturing facility
- Contract research organizations/laboratories.
Key pillars of Quality Management System are as follows:
- Quality Assurance System
- Production System
- Facilities and Equipment System
- Laboratory Control System
- Material System
- Packaging & Labelling Control System
Key documents of Quality Management System:
- Standard Operating Procedures (SOPs) of Quality Assurance, Quality Control, Engineering,
Warehouse, Purchase, Human Resource, Research & Development & Manufacturing department (Tablets, Capsules, Ointment, Liquid orals, Sterile products & APIs)
- Validation Master Plan
- Site Master File
- Facility qualification
- Cleaning Validation Protocol
- Equipment Qualification
- Instrument Qualification
- HVAC Qualification
- Water System Validation
- Compressed Air System Validation
- Nitrogen System Validation
- Stability Studies
- Process Validation
- Analytical Method Validation
- Technology Transfer
- Aseptic Processing or Sterile Products
- Media fill validation
