BMRx – Global Batch Manufacturing Record (BMR) Services for Hong Kong
DH-Aligned | PIC/S GMP Compliant | Inspection-Ready
BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for pharmaceutical and regulated-industry companies in Hong Kong supplying to local and international regulated markets.
Since 2008, BMRx has supported manufacturers, importers, and MAHs across Asia with regulatory-compliant, authority-acceptable BMR documentation, ensuring alignment with Hong Kong Department of Health (DH) requirements, PIC/S GMP, and global inspection readiness.
Who We Serve in Hong Kong
We work with Hong Kong–based organizations involved in:
• Manufacturing for the Hong Kong domestic market (DH – Drug Office)
• Import, re-packaging & secondary manufacturing operations
• Export to Mainland China, ASEAN, US, EU, UK, GCC & other regulated markets
• Contract manufacturing & packaging arrangements
• Technology transfer & site qualification projects
• DH inspections, PIC/S audits & customer audits
Our BMR Services for Hong Kong Companies
✅ BMR Preparation
We prepare product-specific, process-driven BMRs aligned with:
• Hong Kong Department of Health (DH) GMP requirements
• PIC/S GMP Guidelines
• WHO GMP
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
Key Features:
• Facility-specific, non-generic BMRs
• Clear segregation of manufacturing, packaging & QC activities
• Operator-friendly and inspection-ready formats
• Fully traceable batch documentation suitable for DH & PIC/S inspections
✅ BMR Review & PIC/S GMP Compliance Check
Independent technical and GMP review of existing BMRs to identify:
• Missing DH / PIC/S GMP elements
• Data integrity and documentation gaps
• Inspection-critical weaknesses
• Gaps against export market regulatory expectations
Deliverables include clear, actionable remediation recommendations.
✅ Regulatory Query & Inspection Support
Support during:
• Hong Kong DH post-submission queries
• PIC/S GMP inspections & follow-ups
• Customer & third-party audits
• Cross-border regulatory reviews
Including:
• Authority query responses
• Inspection observation remediation
• CAPA-linked BMR corrections
✅ Gap Assessment & Remediation
Comprehensive gap analysis of existing BMRs against:
• Hong Kong DH GMP requirements
• PIC/S GMP expectations
• WHO & export market MOH requirements
With practical, floor-ready corrective actions suitable for Hong Kong manufacturing and packaging environments.
✅ Customized BMR Templates
Provision of ready-to-use, regulator-accepted BMR templates, customized based on:
• Dosage form & packaging configuration
• Equipment & batch size
• Manufacturing / packaging / labeling process
• Facility layout & utilities
• Target export markets
Our Global Experience (Supporting Hong Kong from India)
• 3000+ BMRs prepared & reviewed
• Operational since 2008
• Experience across:
– Hong Kong
– China & Greater Bay Area
– ASEAN
– Middle East
– Africa
– Europe
– LATAM
Product Categories Supported:
• Finished dosage forms
• APIs & intermediates
• Cosmetics & personal care
• Herbal & traditional medicines
• Nutraceuticals & food ingredients
• Chemicals & specialty products
Regulatory Interaction Experience With:
• Hong Kong Department of Health (DH)
• PIC/S Authorities
• US FDA
• EU Authorities
• WHO
Regulatory Standards Followed
All BMR documentation is prepared in accordance with:
• Hong Kong DH GMP Guidelines
• PIC/S GMP Requirements
• WHO GMP
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP Guidelines
• ICH Q7 / Q8 / Q9 / Q10 (where applicable)
• Country-specific MOH expectations for exports
Industries We Support in Hong Kong
• Pharmaceutical Finished Dosage Forms
• APIs & Bulk Drugs
• Cosmetics & Personal Care
• Herbal & Traditional Medicines
• Nutraceuticals & Food Ingredients
• Industrial & Specialty Chemicals
Why Hong Kong Companies Choose BMRx
• 🇭🇰 Strong understanding of Hong Kong DH & PIC/S GMP expectations
• 🌍 Export-oriented BMRs accepted globally
• 📋 Inspection-ready & auditable documentation
• 🔍 Reduced inspection observations
• 🧠 Integrated technical, GMP & regulatory expertise
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional & deadline-driven delivery
• 👷 Operator-friendly formats for shop-floor execution
How We Initiate a BMR Project
To initiate BMR preparation or review, we typically require:
• Product & formulation details
• Manufacturing / packaging process & flow diagrams
• Equipment list & batch size
• Target markets & regulatory pathway
• Existing BMRs (if available)
Based on this, we provide:
• Customized technical scope
• Clear timelines
• Transparent commercial proposal
BMRx
Batch Manufacturing Records. Built for Compliance. Ready for Inspection.
Supporting Hong Kong companies for global regulatory success.