COMPLIANCE FIRST Audit & Compliance Pathways Built for speed, trust, and scale 4 with the patient at the center. Request Audit View Certifications

Audits Are Not Events 4 They Are Systems At GNH India Pharmaceuticals Limited, trust is earned through transparency, governance, and repeatable execution. As a WHO- GSDP compliant and ISO 9001:2015 certified organization, we offer structured audit pathways that allow partners to validate our standards at the depth, pace, and format aligned with their internal governance. Whether you are an innovator, institutional buyer, hospital network, or global partner, our audit framework is designed to remove friction, accelerate alignment, and uphold the highest ethical and regulatory standards 4 with patient safety as the constant priority.

Why Audit GNH India? Global Reach Serving governments, hospitals, aid agencies, and pharmaceutical companies across 180+ countries with proven execution excellence. Certified Standards Strong compliance culture built around WHO-GSDP, ISO 9001:2015, and international regulatory norms with continuous monitoring. Audit-Ready Systems Comprehensive coverage of procurement, storage, cold chain, documentation, and delivery with real-time traceability. We welcome partners who value clarity, discipline, and long-term collaboration in their supply chain partnerships.

FAST-TRACK Pathway 1

Digital Compliance Snapshot Quantum-Speed Validation Designed for: Innovator pharmaceutical companies, orphan/access programs, first-time partners, US/EU compliance teams seeking rapid validation. Timeline: 537 business days from request to completion What This Includes: Virtual facility walkthrough (recorded + live session) Compliance document room (WHO-GSDP, ISO, SOP index) Cold-chain monitoring and ERP demonstration QA governance overview and Q&A session Key Principle: No purchase requirement. No hospitality. Governance-first validation for transparency and speed.

PARTNERSHIP Pathway 2

Partner Audit (Remote or On-Site) Standard Industry Practice 01 Scope Definition Partner defines audit scope aligned with internal compliance protocols and risk assessment frameworks. 02 Audit Execution Remote or on-site audit with QA, QC, and Operations team interactions as needed. 03 Report & CAPA Comprehensive audit report delivery with CAPA follow-up as applicable under NDA. Designed for: Innovator partners, CMOs, and long-term pharmaceutical collaborators requiring detailed validation. Governance note: Audits are conducted under NDA and partner compliance protocols. Travel and logistics are managed by the auditing organization to ensure independence.

INSTITUTIONAL Pathway 3

Institutional Procurement Audit Program Designed for: Governments, UN agencies, large hospital groups, and institutional procurement bodies with significant volume requirements. Eligibility: Confirmed institutional procurement intent with defined order thresholds and formal procurement processes. What This Includes: Comprehensive on-site audit and systems walkthrough 1. Cold chain, traceability, ERP, and documentation review 2. Leadership and compliance team engagement sessions 3. Customized reporting aligned with institutional requirements 4. Audit Facilitation: Support for audit logistics may be provided for eligible institutional partners, subject to applicable procurement rules, ethics policies, and local regulations.

What You Will Validate During an Audit Temperature Control Temperature-controlled warehousing with 24/7 monitoring and automated alerts for deviations. Cold Chain Logistics Real-time monitoring systems with validated transport containers and documentation protocols. Batch Traceability Complete batch traceability and serialization systems with digital tracking capabilities. SOPs & QA Systems Pharmaceutical handling, packaging SOPs, and comprehensive Quality Assurance/Quality Control systems. ERP Controls ERP-based inventory management and shipment controls with automated compliance checks. Export Documentation Regulatory compliance records and governance workflows for international export operations.

Our Certifications & Compliance WHO-GSDP Certified Good Storage & Distribution Practices certification ensuring international pharmaceutical handling standards. ISO 9001:2015 Quality Management System certification demonstrating commitment to continuous improvement and customer satisfaction. Global Authorization Authorized pharmaceutical exporter to 180+ countries with comprehensive regulatory compliance.

Global Trust, Built Over Time GNH is trusted by governments, hospital networks, UN-linked agencies, and regulated pharmaceutical partners across the USA, Europe, Middle East, Africa, and Asia. Our reputation is built on years of consistent performance and unwavering commitment to quality. Our approach is simple: clarity before scale, governance before speed, and patients before transactions. 180+ Countries Served Global pharmaceutical distribution network 100% Compliance Rate WHO-GSDP and ISO certified operations 24/7 Quality Monitoring Continuous temperature and safety control