Quality Standards
- The Waddhamna facility is designed in compliance with ICH Q7, EU GMP, IPEC, EXCiPACT, and WHO-TRS requirements.
- Warehouse includes de-dusting areas, movable sampling & dispensing booths, and segregated storage areas.
- Controlled entry into production areas with SOP-compliant gowning procedures.
- Processing areas equipped with validated ventilation systems and filtered air.
- Quality Control laboratory equipped with 21 CFR Part 11 compliant instruments.
- Microbiology laboratory compliant with ISO-8 and ISO-5 laminar airflow systems.
- Dedicated control sample storage areas maintained as per ICH guidelines.
| Quality Management System Elements |
|---|
| Change control management |
| Deviation management |
| Market complaint handling |
| Internal audits |
| Process validation |
| Cleaning validation |
| Out-of-specification (OOS) procedures |
| Batch manufacturing records |
| Batch release procedures |
| Equipment & instrument qualification |
| Vendor qualification |
| CAPA implementation |
| Training programs |