Batch Formula Record 

A Batch Formula Record (BFR) is a document used in manufacturing industries, particularly in pharmaceutical, chemical, and food processing sectors. It serves as a detailed record of the formula or recipe used to produce a specific batch of a product. The Batch Formula Record contains comprehensive information about the ingredients, their quantities, manufacturing instructions, processing parameters, quality control measures, and any other relevant details necessary for the production of the batch.

Key components typically included in a Batch Formula Record are:

1. Ingredient List: A list of all the raw materials or components used in the production process, along with their respective quantities. This section may also include details such as lot numbers, expiration dates, and suppliers.

2. Formulation: The specific recipe or formula detailing the proportions of each ingredient required to produce the desired product. This may include precise measurements by weight or volume.

3. Processing Instructions: Step-by-step instructions on how to combine the ingredients, the order of addition, mixing times, temperature requirements, and any other processing parameters necessary for the manufacturing process.

4. Equipment Specifications: Information about the equipment and machinery used in the production process, including calibration details, operating parameters, and maintenance requirements.

5. Quality Control Checks: Procedures for conducting quality control checks and tests during the manufacturing process to ensure the product meets specified standards. This may include in-process testing, sampling protocols, and acceptance criteria.

6. Packaging Instructions: Instructions on how the finished product should be packaged, labeled, and stored.

7. Documentation and Signatures: Space for operators, supervisors, and quality control personnel to record their actions, observations, and any deviations from the standard procedures. Signatures and timestamps are often required to verify that each step of the manufacturing process has been completed as per the Batch Formula Record.

The Batch Formula Record serves as a crucial document for ensuring consistency, traceability, and compliance with regulatory requirements throughout the manufacturing process. It provides a comprehensive record of each batch produced, facilitating quality assurance, troubleshooting, and batch-to-batch comparison for continuous improvement efforts. Additionally, it serves as a valuable reference for future productions and for addressing any potential issues or recalls related to the product.

 

 Example template of a batch formula record in document form:

Batch Formula Record

Product Name: [Enter Product Name] 

Batch/Lot Number: [Enter Batch/Lot Number] 

Date of Production: [Enter Date]

1. Composition:

2. Ingredient	Quantity	Specifications
   Active Ingredient A	[Enter Quantity]	USP Grade, Source: [Enter Source]
   Excipient B	[Enter Quantity]	NF Grade, Source: [Enter Source]
   Excipient C	[Enter Quantity]	BP Grade, Source: [Enter Source]

 

2. Manufacturing Instructions:
3. Preparation:

   - Ensure all equipment is clean and sanitized according to SOP XYZ.

   - Weigh and verify the quantity of each ingredient as per the batch formula.

2. Mixing:

   - Place ingredient A into the mixing vessel.

   - Start mixer at [Enter Speed] RPM.

   - Slowly add excipient B over [Enter Time].

   - Continue mixing for [Enter Time] until uniform blend is achieved.

3. Granulation:

   - Transfer mixture to granulator.

   - Add purified water slowly while mixing until desired granule size is obtained.

4. Drying:

   - Transfer wet granules to drying tray.

   - Dry at [Enter Temperature]°C for [Enter Time].

5. Compression:

   - Pass dried granules through compression machine.

   - Use [Enter Pressure] MPa.

   - Check tablet hardness and weight periodically.

6. Coating:

   - Prepare coating solution according to SOP ABC.

   - Apply coating evenly to tablets in coating machine.

   - Dry coated tablets at [Enter Temperature]°C for [Enter Time].

3. In-process Controls:

- Monitor granule size during granulation process every [Enter Frequency].

- Check tablet weight and hardness during compression process every [Enter Frequency].

4. Packaging Instructions:

- Package tablets in blister packs according to SOP DEF.

- Label packs with batch number, expiration date, and other required information.

5. Quality Control Checks:

- Perform dissolution testing according to USP monograph.

- Assay tablets for potency using HPLC method XYZ.

6. Storage and Handling:

- Store finished product in cool, dry conditions at [Enter Temperature]°C.

- Protect from light and moisture.

- Follow SOP GHI for handling and disposal of waste materials.

7. Safety and Environmental Considerations:

- Wear appropriate PPE during handling of materials.

- Dispose of waste in accordance with local regulations.

8. Batch Records Review and Approval:

Prepared by: [Enter Name] 

Date: [Enter Date]

Reviewed by: [Enter Name] 

Date: [Enter Date]

Approved by: [Enter Name] 

Date: [Enter Date]

References:

- SOPs: XYZ, ABC, DEF, GHI

- USP Monographs: [Enter relevant monograph numbers]

- Regulatory Guidelines: [Enter relevant guidelines]

This template provides a structured format for documenting the batch formula record, ensuring clarity, completeness, and compliance with regulatory requirements. Adjustments can be made based on specific product characteristics and manufacturing processes.