BMRx – Global Batch Manufacturing Record (BMR) Services for South Africa

outh Africa-Compliant | Global GMP Aligned | 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 South African pharmaceutical, API, cosmetic, herbal, food, and chemical manufacturers supplying to domestic and international regulated markets.

Since 2008, BMRx has supported manufacturers across Africa, Europe, North America, Asia, and LATAM with regulatory-compliant, authority-acceptable BMR documentation, enabling smooth approvals, successful inspections, and reduced regulatory observations.

Who We Serve in South Africa

We work with South Africa–based companies involved in:

• Manufacturing for the South African domestic market (SAHPRA)
• Export to US, EU, UK, SADC, GCC, Africa & LATAM
• API & intermediate manufacturing
• Finished dosage forms (OSD, injectables, liquids, semi-solids)
• Contract manufacturing (CMOs & CDMOs)
• Technology transfer and scale-up projects
• Regulatory inspections and GMP audits

Our BMR Services for South African Manufacturers

We provide complete lifecycle support for Batch Manufacturing Records, including:

✅ BMR Preparation

• Preparation of country-specific and export-oriented BMRs aligned with:
o SAHPRA GMP requirements
o US FDA (21 CFR Parts 210 & 211)
o EU GMP
o WHO GMP
o PIC/S GMP
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of CPPs, IPCs, yields, reconciliation, and deviations
• Operator-friendly, inspection-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical, GMP, and data-integrity review of existing BMRs
• Identification of:
o Missing GMP elements
o SAHPRA vs US FDA / EU GMP gaps
o Data integrity and traceability risks
o Inspection-critical weaknesses
• Alignment with current global regulatory expectations

✅ Regulatory Query & Inspection Support

• Support during SAHPRA, US FDA, EU, and WHO inspections
• Handling of BMR-related authority queries:
o Pre-approval inspections
o Routine GMP audits
o For-cause inspections
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Detailed gap analysis of existing BMRs against:
o SAHPRA GMP vs US FDA / EU GMP
o Export-market documentation expectations
• Practical, shop-floor-executable corrective actions
• Risk-based remediation for high-risk and sterile operations

✅ Customized BMR Templates

• Regulator-accepted, ready-to-use BMR templates
• Custom-built based on:
o Dosage form and process technology
o Equipment trains and batch size
o Facility layout & utilities
o Domestic and export market requirements

Our Global Experience (Supporting South Africa from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Extensive experience supporting Africa-to-US / EU / WHO supply chains
• Strong exposure to:
o APIs & intermediates
o Oral solid dosage forms
o Sterile & injectable products
o Cosmetics and nutraceuticals
• Regular interaction with:
o SAHPRA
o US FDA
o EU authorities
o WHO / PIC/S regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• SAHPRA GMP requirements
• WHO GMP Guidelines
• US FDA cGMP (21 CFR Parts 210 & 211)
• EU GMP Guidelines
• PIC/S GMP Requirements
• ICH Q7 / Q8 / Q9 / Q10
• Importing-country MOH and authority expectations

Industries We Support in South Africa

• Pharmaceuticals & APIs
• Finished Dosage Forms
• Injectables & Sterile Products
• Cosmetics & Personal Care
• Herbal & Natural Products
• Food & Nutraceutical Ingredients
• Chemicals & Industrial Products

Why South African Manufacturers Choose BMRx

• 🌍 Export-oriented BMRs accepted by SAHPRA, US FDA & EU
• 📋 Inspection-ready, auditable documentation
• 🔍 Reduced regulatory observations
• 🧠 Strong understanding of African & global GMP alignment
• 🛠️ Non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Operator-friendly formats for shop-floor execution

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product and formulation details
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target export markets and regulatory strategy
• 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 South African manufacturers for global regulatory success.