Batch Manufacturing Record (BMR) Format for Chemical Factories: A Complete Compliance Guide

🧪 Introduction: What Is a Batch Manufacturing Record (BMR)?

In the chemical manufacturing industry, every batch of product you create must be documented in detail. This is where the Batch Manufacturing Record (BMR) comes in.

A BMR is a written record of the manufacturing history of a specific batch. It captures everything — raw materials used, processes followed, parameters monitored, equipment cleaned, and final product testing.

Whether you’re making:

  • Industrial solvents
  • Active Pharmaceutical Ingredients (APIs)
  • Agrochemicals
  • Dyes and intermediates
    …a proper BMR ensures traceability, quality, and legal compliance.

Maintaining BMRs isn’t just a formality — it’s required by:

  • GMP (Good Manufacturing Practices)
  • ISO 9001
  • BIS (Bureau of Indian Standards)
  • FDA, if you’re exporting to regulated countries

📋 Why BMR Is Essential in the Chemical Industry

Purpose Benefits
✅ Quality Assurance Ensures consistent manufacturing and raw material control
✅ Compliance Mandatory for audits by BIS, FDA, ISO, state drug departments
✅ Traceability Helps trace any quality issue to a specific batch or operator
✅ Legal Protection Serves as evidence in case of disputes, recalls, or complaints
✅ Buyer Confidence Trusted by international clients and regulatory bodies

If your factory is exporting or contract manufacturing, having GMP-compliant BMRs is non-negotiable.


🧾 What Does a Standard BMR Contain?

A well-structured BMR should cover the entire lifecycle of the batch, including:

  1. Batch details (product name, code, batch number)
  2. Raw materials used (quantity, supplier, batch number)
  3. Equipment cleaning logs
  4. Process steps with timings and conditions
  5. In-process testing and adjustments
  6. Yield calculations
  7. Final product specifications
  8. Packaging information
  9. Signatures of production and QA staff

📑 Standard BMR Format for a Chemical Product

Here’s a typical GMP-compliant format used by Indian chemical manufacturers:


🔹 1. Product and Batch Information

Field Value
Product Name Ethyl Acetate
Batch Number EA-2025-003
Batch Size 1000 Liters
Date of Manufacture 20 June 2025
Date of Expiry 20 June 2027
Manufacturing Site ABC Chemicals Pvt Ltd, Ankleshwar
Mfg License No. GJ/CHEM/257/2019

🔹 2. Raw Material Input Sheet

Material Grade Lot No. Quantity Source
Ethanol 99.9% E00125 600 L India Glycols
Acetic Acid Glacial A0067 450 L Jubilant Ingrevia
Sulfuric Acid 98% S0123 10 L Deepak Nitrite

Each raw material must be verified and labeled with its Certificate of Analysis (COA).


🔹 3. Equipment and Cleaning Verification

Equipment ID Cleaned (Y/N) Date Verified By
Reactor R1 5000 L Yes 19 June QA Officer
Agitator A1 Yes 19 June Production Head
Transfer Pump P3 Yes 20 June Operator

Attach CIP (Clean-In-Place) records here.


🔹 4. Manufacturing Process Log

Step No. Description Parameter Time Status
1 Charge Ethanol Temp 25°C 8:00 AM OK
2 Add Acetic Acid dropwise pH ~3 9:00 AM OK
3 Add Sulfuric Acid (catalyst) 1% 9:30 AM OK
4 Heat to 70°C for esterification Temp 70°C 10:00 AM – 12:00 PM OK
5 Cool and transfer 25°C 1:00 PM OK

🔹 5. In-Process Testing Record

Test Specification Result Done By
pH 6.0 – 7.5 6.9 Lab Chemist
Water Content <1.0% 0.6% QC Analyst
Specific Gravity 0.90–0.91 0.905 QA Officer

Results must match product Standard Operating Procedure (SOP).


🔹 6. Final Yield and Packaging

Theoretical Yield Actual Yield Yield % Acceptable Range
1000 L 980 L 98% 95–100% ✅
Packaging Type Quantity Labeling Checked?
HDPE Drums 20 × 50 L Yes
Bulk Tank 1 × 1000 L Yes

🔹 7. Deviations / Incidents (if any)

If there were any issues (equipment failure, delay, missing labels), mention them here with corrective action and justification.

Deviation No. Description Approved By Remarks
D-25-03 Slight temperature drop during Step 4 QA Manager Within acceptable limit ✅

🔹 8. Final Product Approval

Test Specification Result Status
Appearance Clear, colorless Pass
Assay ≥99% 99.3% Pass
Impurities <1% 0.7% Pass

Attach full Certificate of Analysis (COA) signed by QA.


🔹 9. Authorization and Signatures

Stage Name Signature Date
Prepared By R. Mehta 20 June
Checked By S. Yadav 21 June
Approved By QA Manager 21 June
Released By Plant Head 21 June

📄 Free Download: BMR Template (Word / Excel)

Offer visitors a downloadable, editable BMR template:

Link: /downloads/BMR-Chemical-Template-India.docx


⚠️ Common Mistakes in BMR That Lead to Audit Failures

Mistake Consequence
Missing raw material batch number Traceability lost
No signature of QA Product can’t be released
Incorrect yield calculation Deviation report required
No in-process test records GMP non-compliance
Unapproved format Audit red flag

Tip: Conduct internal QA audits every 3–6 months.


🧠 Digital BMRs: The Future of Documentation

Modern factories are switching to Digital BMRs using:

  • ERP software (BatchMaster, Marg ERP)
  • Custom Excel automation with macros
  • Cloud document storage (Google Drive, OneDrive)
  • QR codes for packaging traceability

This reduces paperwork and increases compliance speed.


📈 High CPC Keywords and Blog Value

BMR content attracts:

  • Quality consultants
  • ERP software advertisers
  • ISO/BIS compliance services
  • Chemical documentation agencies
  • SOP writing and COA services

Example CPCs:

Keyword CPC (INR)
“BMR format chemical factory” ₹150
“batch manufacturing record GMP” ₹180
“download BMR template India” ₹210
“chemical documentation services” ₹250+

✅ Conclusion: Build Compliance and Trust with a Solid BMR

Whether you’re a small chemical blender or a large-scale exporter, your Batch Manufacturing Record (BMR) is proof of quality, compliance, and credibility.

By using a standardized, GMP-compliant BMR format, you’ll:

  • 📋 Pass audits confidently
  • 🌍 Satisfy international buyers
  • 🧾 Avoid costly rejections or recalls
  • 💰 Improve traceability, yield, and profits
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