BMRx – Batch Manufacturing Record (BMR) Services in Surat

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, providing end-to-end Batch Manufacturing Record (BMR) Preparation, Review, and Remediation Services for pharmaceutical, API, chemical, and allied manufacturers in Surat and South Gujarat supplying to Indian and international regulated markets.

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

Who We Serve in Surat & South Gujarat

We work closely with companies involved in:

• Pharmaceutical formulation manufacturing
• APIs, intermediates & bulk drugs
• Chemical, specialty chemical & dye intermediates
• Pharmaceutical 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 Surat 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
• Clear 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 observed in 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
– Target domestic & export markets

Our Experience in Surat & South Gujarat Clusters

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience with Surat, Sachin, Pandesara, Hazira, Bardoli, Vapi 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 Surat

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

Why Surat 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 Surat manufacturers for India and global regulatory success.