How to Create a Batch Manufacturing Record (BMR)

An essential document for pharmaceutical manufacturing is the Batch Manufacturing Record (BMR). The BMR contains all the details on how to make a specific batch of product and is a record of evidence that will confirm that the batch was manufactured according to approved procedures. An ideal BMR supports the quality, traceability, consistency and regulatory compliance of the product.

During an inspection, an examiner will check BMRs to determine if the facility is in compliance with Good Manufacturing Practice (GMP). As a result, many errors, omissions or incomplete documentation issues in BMRs are frequently cited as findings during audits. As such, companies must develop their BMRs in a methodical and controlled manner to ensure they are accurate.

What is a Batch Manufacturing Record?

A Batch Manufacturing Record (BMR) is an official document that contains all the specific instructions and records required to manufacture a specific batch of a pharmaceutical product. The BMR contains many different types of information including:

• Product Information
• Manufacturing Instructions
• Material Additions
• Equipment Information
• In-Process Checks
• Operator Signatures
• Yield Information
• Packaging Information

The BMR is also used as both an instructional document and a permanent record of the manufacturing of a product.

Importance of a BMR in Pharmaceuticals

The BMR is very important in pharmaceutical manufacturing as it provides complete traceability of each batch manufactured. The BMR can help provide:

• Continuity in manufacturing
• Reducing errors in operations
• Preserving data integrity
• Supporting investigations
• Providing proof of compliance with regulations

Without the BMR being properly maintained, it can be difficult to provide proof of compliance with all Manufacturing activities.

Objectives of a Batch Manufacturing Record

The primary objective of a BMR is to ensure that each batch is manufactured according to an approved procedure. Other objectives of a BMR include:

• Providing step-by-step production instructions
• Recording production activity
• Capturing Process Critical Data
• Supporting Decisions for release of batches
• Facilitating Investigations and Recalls

With a well-written BMR, the manufacturer can maintain both process control and the quality of their products.

Difference Between BMR and BPR

The terms BMR (Batch Manufacturing Record) and BPR (Batch Packaging Record) often create confusion.
BMR: Relates to the elements of manufacturing which include: dispensation, granulation, compression and coating.
BPR: Relates to the elements of packaging such as labelling, cartoning and packing operations.
In some companies both records may be combined into one record.

Key Sections of a Batch Manufacturing Record

The BMR should include all of the necessary information to carry out the manufacture and the documentation.

1. Product Information Section

This section includes basic product identification details including:

• Product name
• Strength
• Dosage form
• Batch number
• Batch size
• Date manufactured
• Expiry date

These details all help to identify a particular lot.

2. Bill of Materials

The BMR will also have the bill of materials for all raw materials needed to manufacture the product.
This includes:

• Material name
• Material code
• Quantity
• Weighing instructions
• Dispensing instructions

This section will ensure the correct and accurate materials were used in the manufacture of the product.

3. Equipment and Area Information

The BMR should contain a list of items of the equipment used to manufacture the product.
In addition, the BMR should include the following:

• Equipment name
• Equipment ID no.
• Equipment cleaning status
• Area line clearance status

These will establish that all equipment used to manufacture the product was cleaned and approved.

4. Manufacturing Instructions

This is an essential area within the BMR. This section provides comprehensive instruction for the procedures that will be used in the manufacture of this product. Examples might include:

• Mixing parameters
• Granulation
• Drying temperature
• Compression settings
• Coating parameters

Written instructions should be precise, definitive and easy to follow.

5. In-Process Checks

In-process checks are intended to confirm that the finished product meets acceptance criteria during the manufacturing operation. Examples might include:

• Tablet weight variation
• Hardness testing
• Disintegration testing
• Moisture

The BMR should establish:
- How often to sample each item
- What criteria to use as the basis for acceptance of the sample item
- How to document the results for each item

6. Yield Reconciliation Section of BMR

Yield calculations play an important role in controlling your inventory of product and raw materials.
The BMR should document:

• Theoretical yield
• Actual yield
• Percentage of yield
• Losses

Any deviation that is encountered outside of your calculated yield should be thoroughly reviewed.

7. Packaging Information

When packaging has been defined in the BMR, the following details should be included in this section:

• Packaging material
• Labeling history/issuance
• Reconciliation
• Packaging Instructions

This permits the ability to trace packaging components throughout your product life cycle.

8. Deviations and Remarks Section of BMR

During the manufacture of this product, any exception or abnormal situation that is noted must be recorded. Examples may include:

• Equipment failure
• Interruption of the process
• Environmental problems

A record must be maintained to defend against any subsequent investigations or corrective action/preventive action activities.

9. Signatures and Approvals

The BMR must include the signature of the personnel that have responsibility for the area listed in the BMR. Typically the signatures of personnel would include:

• Production operator
• Production supervisor
• Quality assurance reviewer

The signatures will provide documentation of accountability and confirm that the documentation has been reviewed.

Procedure for Creating a Batch Manufacturing Record

There should be a systematic process for developing a Batch Manufacturing Record.

Step 1: Collect product and procedure information

Necessary information includes:

• Product formulation
• Manufacturing process
• Required equipment
• Process parameters

This information must be collected from authorized Master documents.

Step 2: Review the Master Formula Record

The Master Formula Record will serve as the overarching document from which to develop the Batch Manufacturing Records. The Master Formula Record contains:

• Approved formulation
• Instructions for processing
• Critical manufacturing phase parameters

The Batch Manufacturing Record must match the approved information contained in the Master Formula Record.

Step 3: Define Manufacturing Steps Clearly

Instructions for completing each manufacturing phase must be outlined sequentially and in a manner that removes ambiguity.

• Quantities
• Operating characteristics
• Equipment settings
• Precautions

Writing clearly will limit the potential for mistakes when putting the product together.

Step 4: Include Data Recording Fields

There needs to be enough room available to enter data during the making of the product:

• Date and time
• Equipment Identification
• Observations
• Test Data

The completed entries must be legible and easy to follow.

Step 5: Define In-Process Controls

Identify critical inspections that will be performed during manufacturing and create documentation that means the acceptance requirements for each critical inspection are clearly defined.

Step 6: Add Reconciliation and Yield Sections

Material accountability is the key to preventing mix-ups and losses. The BMR should contain reconciliation calculations for:
- Raw materials
- Printed Packaging materials
- Finished product quantities

Step 7: Review by Cross-Functional Team

The draft BMR will be reviewed by:

• Production department
• Quality Assurance
• Quality Control

This also ensures technical accuracy and compliance.

Step 8: Approval and Issuing

The BMR should be approved through document control procedures after it has been reviewed. Control Copies will then need to be issued to be used for manufacture.

GMP Compliance Requirements for BMR

Regulatory agencies expect biopharmaceutical manufacturers to follow the proper guidelines for BMRs while utilizing Good Manufacturing Practices and to keep the following GMP requirements in mind for BMR compliance:

• Legibility of entries
• Documentation is created in real-time
• No unauthorized changes
• Controlled document distribution and creation
• Ultimate traceability

Failure to document BMRs correctly could result in regulatory observations.

Common Errors of BMR Preparation

There are many common mistakes that can decrease the quality of BMRs:

• Omissions in the process
• Not enough writing space
• Confusing instructions
• Bad calculations
• No signatures of approvals

All of these errors can cause confusion during manufacturing and audit periods.

Best Practices for Effective BMR Creation

The following best practices are recommended for the effective creation of BMRs:

• Use of clear and simple language
• Standardized document format
• Critical process information
• Needless complexity should be avoided
• Training of persons involved in BMR documentation

Creating user-friendly BMRs helps support compliance and good operational efficiencies.

Electronic Batch Manufacturing Records (EBMR)

Many biopharmaceutical companies are implementing electronic batch records for BMRs. The benefits of utilizing an EBMR include:

• Improved data integrity
• Fewer errors in documentation creation
• Quicker BMR reviews
• Improved traceability

Electronic recordkeeping systems must comply with the regulations for the creation and use of electronic records and signatures.
Sample Batch Manufacturing Record (BMR)

Batch Manufacturing Records are critical documents within the pharmaceutical manufacturing process that include all documentation needed to document production activity. A properly defined BMR can help provide uniformity amongst lots, allow tracking of raw materials used in production, provide assurance of data integrity and provide a means to verify regulatory compliance.

Through the use of structured processes, defined process pathways and detailed documentation procedures, pharmaceutical companies can develop BMRs that allow for effective (quality) products and operational control. A good BMR system is essential to compliance and pharmaceutical companies are responsible for their actions related to protecting patient safety in a regulated industry.

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