Zero-Compromise Pharmaceutical Quality
From raw API sourcing to final release, our multi-tiered QA/QC governance guarantees safety and clinical efficacy.
Quality Assurance (QA)
Our QA protocols govern the entire product life cycle—from vendor qualification and raw material validation to batch processing, packaging integrity, and post-market surveillance.
- Standard Operating Procedures (SOP) Validation
- Change Control & CAPA Auditing System
- Vendor Purity & DMF Verification Benchmarks
Quality Control (QC)
Analytical release testing utilizing calibrated HPLC, UV Spectrophotometry, dissolution apparatus, and microbial incubators to guarantee exact active potency and zero impurity profile.
- High-Performance Liquid Chromatography (HPLC)
- Microbial Bioburden & Sterility Checks
- Dissolution Profile & Friability Validation
Manufacturing Standards
Manufactured in state-of-the-art c-GMP certified facilities with HEPA filtration, Class 100,000 cleanroom environments, and automated blister packaging systems.
- Automated High-Speed Blister Packing
- AHU Air-Handling Cleanroom Systems
- Strict Temperature & Humidity Loggers
Regulatory Compliance
Comprehensive product dossiers prepared in CTD format to streamline drug regulatory approvals and registration across Asian and African Ministry of Health (MOH) authorities.
- ACTD / CTD Format Dossier Documentation
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (COA) for Every Batch
Audited & Compliant Facilities
All production lines partnering with UNiFiC PHARMA operate under accredited WHO-GMP compliance, undergoing routine third-party audits and stringent batch release authorizations.
Request Quality Audit Dossier