BMRx – Batch Manufacturing Record (BMR) Services in Vapi

Gujarat State FDA | CDSCO | US FDA | EU GMP | WHO | PIC/S Compliant
API & Chemical Cluster Focused | Inspection-Ready | Export-Oriented

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, delivering end-to-end Batch Manufacturing Record (BMR) Preparation, Review, and Remediation Services for pharmaceutical, API, chemical, and allied manufacturers in Vapi and the Valsad industrial belt supplying to Indian and international regulated markets.

Since 2008, BMRx has supported Vapi-based API parks, chemical plants, formulation units, CMOs, and export-oriented manufacturers with regulatory-compliant, authority-acceptable BMR documentation, enabling inspection readiness, smoother approvals, and reduced regulatory observations.

Who We Serve in Vapi & South Gujarat

We work closely with companies involved in:

• API & bulk drug manufacturing
• Intermediates, fine chemicals & specialty chemicals
• Pharmaceutical formulation units
• Contract manufacturing (CMOs & CDMOs)
• Manufacturing for Indian market (CDSCO & Gujarat State FDA)
• Export to US, EU, UK, ASEAN, GCC, Africa & LATAM
• Technology transfer, scale-up & plant expansion projects
• Companies preparing for US FDA, EU GMP, WHO, CDSCO inspections

Our BMR Services for Vapi Manufacturers

✅ BMR Preparation

We develop process-driven, plant-specific BMRs aligned with:

• Indian GMP (Schedule M)
• Gujarat State FDA expectations
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• WHO GMP
• PIC/S GMP Requirements
• ICH Q7 (API & intermediates)
• ICH Q8 / Q9 / Q10 (where applicable)

Key Features
• Reactor-wise and equipment-specific BMRs
• Strong control of CPPs, IPCs & yield reconciliation
• Data-integrity-focused, audit-defensible documentation
• Operator-friendly shop-floor execution formats

✅ BMR Review & GMP Compliance Check

Independent technical and GMP review of existing BMRs to identify:

• Missing GMP or ICH Q7 elements
• Inadequate CPP, IPC, or yield documentation
• Data integrity & traceability gaps (ALCOA+)
• Inspection-critical weaknesses highlighted during audits

Outcome: Corrected, strengthened BMRs aligned with current global regulatory expectations.

✅ Regulatory Query & Inspection Support

Support for BMR-related queries during:

• Gujarat State FDA & CDSCO inspections
• US FDA audits
• EU GMP & WHO inspections
• Pre-approval & post-approval inspections
• Post-inspection CAPA implementation

Includes BMR corrections, justifications, and regulator-acceptable responses.

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
– Updated Schedule M
– ICH Q7 requirements
– US FDA & EU GMP expectations
• Practical, plant-ready corrective actions
• Alignment with validation, cleaning & quality systems

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
– Reactor / equipment type
– Batch size & scale
– Process chemistry
– Utilities & plant layout
– Domestic & export regulatory pathways

Our Experience in Vapi API & Chemical Cluster

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Vapi, Valsad, Sarigam, Umbergaon, Silvassa industrial clusters
• Strong exposure to API & chemical export-oriented facilities

Product Categories Covered
• APIs & intermediates
• Bulk drugs
• Specialty & industrial chemicals
• Agrochemical actives
• Finished dosage forms

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Indian GMP (Schedule M)
• ICH Q7 (API GMP)
• WHO GMP Guidelines
• US FDA cGMP (21 CFR 210 & 211)
• EU GMP (Part II – APIs)
• PIC/S GMP Requirements
• ICH Q8, Q9, Q10 (where applicable)
• Country-specific MOH requirements for exports

Industries We Support in Vapi

• APIs & bulk drugs
• Chemical & specialty chemical manufacturing
• Pharmaceutical formulations
• Agrochemicals
• Contract manufacturing units

Why Vapi Manufacturers Choose BMRx

• 🧪 Deep understanding of API & chemical manufacturing realities
• 🌍 Export-oriented, globally acceptable BMRs
• 📋 Inspection-ready, audit-defensible documentation
• 🔍 Reduced US FDA & EU GMP observations
• 🧠 Strong technical, GMP & regulatory expertise
• 🛠️ Reactor-specific, non-generic BMRs
• 🔒 Confidential, professional & deadline-driven execution
• 👷 Practical formats designed for shop-floor use

How We Start the Project

To initiate BMR preparation or review, we typically request:

• Product / API details
• Process chemistry and flow diagrams
• Reactor & equipment list
• Batch size and scale
• Target export markets
• 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 Vapi manufacturers for India and global regulatory success.