Quality & Compliance
Quality Assurance & Quality Control
Compliance isn’t a final checkpoint — it’s engineered into our process from raw material intake to final release.
Quality Assurance
A Documented, Auditable Quality System
We follow GMP, ICH & ISO guidelines to maintain the robustness of our quality management system. As part of this, all the key elements mentioned below (but not limited to) are well maintained.
Quality System / Documentation
- Standard Operating Procedures (SOPs)
- Risk Management System
- Training Management System
- Vendor Management System
- Test Procedures & Protocols
- Master Formula Records
- Disposal Records
Associated Records & Procedures
- Site Master File, Validation Master Plan, Quality Manual
- Management Review Meeting System
- Self-Inspection System
- Specification of all Materials & Finished Products
- Stability Study
- Batch Manufacturing Record & Batch Packing Record
- Release Records & Distribution Records
Quality system documentation is maintained by NovaAcura Biotech, mapped to its associated records and procedures.
Quality Control
A Well-Equipped In-House QC Laboratory
NovaAcura Biotech has a well-equipped quality control laboratory to carry out all major analyses as per different pharmacopoeias. Environment monitoring and microbiological analysis are also carried out in-house.
The QC lab is divided into:
Wet Lab
Hot Zone
Instrument Room — GC-HS / HPLC / UV-VIS Spectrophotometer
Stability, Microbiology & MLT Room
Have a Question About Our Quality Systems?
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