BMRx – Global Batch Manufacturing Record (BMR) Services for Afghanistan

Afghanistan-Compliant | WHO-Aligned | Export-Ready Documentation

BMRx is a specialized scientific arm of Zoesoe Exports Pvt Ltd, providing end-to-end Batch Manufacturing Record (BMR) Preparation & Review Services for Afghan pharmaceutical, herbal, nutraceutical, cosmetic, food, and chemical manufacturers supplying to domestic, humanitarian, and international regulated markets.

Since 2008, BMRx has supported manufacturers across Asia, the Middle East, Africa, Europe, and LATAM with regulatory-compliant, authority-acceptable BMR documentation, enabling product registrations, WHO procurement eligibility, and export approvals.

Who We Serve in Afghanistan

We work with Afghanistan-based organizations involved in:

• Manufacturing for the Afghan domestic market (Ministry of Public Health – MoPH)
• Local pharmaceutical production units
• Herbal & traditional medicine manufacturers
• Nutraceutical, food supplement & dietary products
• Humanitarian & donor-funded supply programs
• Export to Central Asia, South Asia, Middle East, Africa & NGOs / UN agencies

Our BMR Services for Afghan Manufacturers

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

✅ BMR Preparation

• Preparation of Afghanistan-compliant and export-oriented BMRs aligned with:
o Afghanistan MoPH requirements
o WHO GMP Guidelines
o PIC/S GMP (where applicable)
o US FDA / EU GMP (for export-oriented facilities)
• Product-specific, process-driven, non-generic BMRs
• Clear documentation of raw material control, manufacturing steps, IPCs, yields, and reconciliation
• Simple, operator-friendly, audit-ready formats

✅ BMR Review & GMP Compliance Check

• Independent technical and GMP review of existing BMRs
• Identification of:
o Missing GMP elements
o Documentation gaps affecting registration or procurement
o Data integrity and traceability risks
• Alignment with WHO and importing-country expectations

✅ Regulatory Query & Inspection Support

• Support for MoPH, WHO, NGO, and importing-country authority queries
• Assistance during:
o Product registration
o WHO / donor audits
o Export approvals
• CAPA-linked BMR corrections and upgrades

✅ Gap Assessment & Remediation

• Gap analysis of existing BMRs against:
o WHO GMP requirements
o Export-market documentation needs
• Practical, floor-ready corrective actions suitable for emerging facilities

✅ Customized BMR Templates

• Ready-to-use, regulator-accepted BMR templates
• Customized based on:
o Product category (pharma, herbal, food, cosmetic)
o Batch size & available equipment
o Facility layout & utilities
o Domestic and export market goals

Our Global Experience (Supporting Afghanistan from India)

• 3000+ BMRs prepared and reviewed
• Operational since 2008
• Strong experience supporting emerging & developing-market manufacturers
• Extensive work across:
o South & Central Asia
o Middle East
o Africa
• Exposure to:
o Essential medicines
o Herbal & traditional products
o Nutraceuticals & food supplements
• Regular interaction with:
o WHO
o National Ministries of Health
o Importing-country regulators

Regulatory Standards Followed

All BMR documentation is prepared in line with:

• Afghanistan Ministry of Public Health requirements
• WHO GMP Guidelines
• PIC/S GMP (where applicable)
• US FDA cGMP (for exports, where required)
• EU GMP (for exports, where required)
• ICH Q7 / Q9 (where applicable)

Industries We Support in Afghanistan

• Pharmaceuticals & Essential Medicines
• Herbal & Traditional Medicine Products
• Nutraceuticals & Food Supplements
• Food Processing & Ingredients
• Cosmetics & Personal Care
• Natural Extracts & Essential Oils
• Chemicals & Industrial Products (limited-scope GMP)

Why Afghan Manufacturers Choose BMRx

• 🌍 Strong WHO-aligned documentation expertise
• 📋 Export-ready and procurement-acceptable BMRs
• 🔍 Reduced registration & audit observations
• 🧠 Deep experience with emerging-market GMP realities
• 🛠️ Practical, non-generic, process-specific BMRs
• 🔒 Confidential, professional, and deadline-driven
• 👷 Simple, operator-friendly formats

How We Start the Project

To initiate BMR preparation or review, we typically require:

• Product details and formulation
• Manufacturing process & flow diagram
• Equipment list and batch size
• Target markets (domestic / export / NGO supply)
• 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 Afghan manufacturers for domestic, humanitarian & global regulatory success.