Certifications & Compliance Alignments
Maintaining high international benchmarks for active pharmaceutical raw materials and finished dosage supply.
WHO-GMP Compliant Manufacturing
Jani Pharma sources APIs and finished formulations exclusively from manufacturing units operating in full compliance with World Health Organization Good Manufacturing Practices (WHO-GMP). This ensures robust environmental control, cleanroom protocols, and automated filling lines.
WHO Compliance Guidelines
Our trade quality assurance policies align with WHO recommendations for pharmaceutical supply chains, emphasizing sample retention, verified batch records, batch traceability, and stability data verification.
ISO 9001:2015 Standards
Operational processes for sourcing, document management, client order execution, and export dispatch are aligned with ISO 9001:2015 quality management system principles for continuous process improvement.
EU-GMP Standard Alignment
Selected Active Pharmaceutical Ingredients (including USP Etomidate API Powder) meet strict European Pharmacopoeia analytical standards for chemical purity, residual solvents, and heavy metal limits.
Quality Assurance & Verification Protocol
1. COA Verification
Every API lot is accompanied by a batch Certificate of Analysis detailing HPLC assay percentage, melting point, loss on drying, and related substances.
2. Document Traceability
Complete chain of custody documentation from factory synthesis to container loading, ensuring full audit readiness for international buyers.
3. Packaging Compliance
Airtight double polybag inner liners within heavy-duty HDPE fiber drums to protect API powders against humidity degradation during sea or air transit.
