Master Formula Record

A Master Formula Record (MFR) is a comprehensive document utilized in regulated industries such as pharmaceuticals, biotechnology, food, and cosmetics manufacturing. It serves as a detailed set of instructions and specifications for the production of a specific product or formulation. The MFR contains crucial information about the composition, manufacturing process, quality control procedures, packaging requirements, and any other relevant details necessary for the consistent and reproducible manufacturing of the product.

 Key components included in a Master Formula Record:

1. Composition: Detailed listing of all ingredients, including their quantities, specifications, and sources. This section may also include information on excipients, active ingredients, and any additives used in the formulation.

2. Manufacturing Process: Step-by-step instructions outlining the procedures and parameters for manufacturing the product. This includes specific equipment requirements, mixing instructions, temperature and time parameters, and any other critical processing conditions.

3. Quality Control Measures: Specifications for testing and evaluating the quality of both raw materials and finished products. This may include analytical testing methods, acceptance criteria, sampling plans, and procedures for handling deviations or out-of-specification results.

4. Packaging Instructions: Guidelines for packaging the finished product, including container types, labeling requirements, batch numbering, expiry dating, and any special handling instructions.

5. Storage and Distribution: Recommendations for the storage conditions and transportation of the finished product to ensure stability and maintain product integrity throughout its shelf life.

6. Safety and Regulatory Compliance: Information on safety precautions, regulatory requirements, and any applicable legal or quality standards that must be adhered to during the manufacturing process.

7. Version Control and Revisions: A system for documenting changes, updates, and revisions to the MFR, including the date of each revision and the individuals responsible for approving and implementing changes.

The Master Formula Record plays a crucial role in ensuring product consistency, quality, and regulatory compliance throughout the manufacturing process. It serves as a reference document for production personnel, quality assurance teams, regulatory authorities, and other stakeholders involved in the manufacturing and distribution of the product. Maintaining accurate and up-to-date MFRs is essential for meeting Good Manufacturing Practices (GMP) and other regulatory requirements in highly regulated industries.

Outline of the typical instructions included in a Master Formula Record-

Master Formula Record

Product Name: [Enter Product Name] 

Reference Number: [Enter Reference Number] 

Effective Date: [Enter Effective Date]

1. Product Information:

- Product Name: [Enter Product Name]

- Dosage Form: [Enter Dosage Form]

- Strength: [Enter Strength]

- Packaging Size: [Enter Packaging Size]

- Reference Standard: [Enter Reference Standard]

- Approved Label Claims: [Enter Approved Label Claims]

2. Composition:

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]

 

3. Manufacturing Instructions:
4. Preparation of Ingredients:

   - Specify the method for preparation of each ingredient.

   - Include instructions for any special handling or processing requirements.

2. Mixing and Blending:

   - Detail the steps for mixing or blending ingredients together.

   - Specify equipment to be used and mixing parameters (e.g., speed, time).

3. Granulation (if applicable):

   - Provide instructions for granulation process, if necessary.

   - Include parameters such as granule size and moisture content.

4. Tableting or Encapsulation:

   - Describe the process for forming tablets or capsules.

   - Specify equipment, compression force, and other relevant parameters.

5. Coating (if applicable):

   - If coating is required, provide instructions for coating process.

   - Include details on coating solution preparation, equipment, and coating parameters.

6. Packaging:

   - Detail the packaging process, including primary and secondary packaging.

   - Specify labeling requirements and any special instructions for packaging materials.

4. In-process Controls:

- Specify in-process testing and monitoring procedures.

- Include acceptance criteria for each in-process control point.

5. Storage and Handling:

- Provide instructions for storage conditions of raw materials, intermediates, and finished products.

- Specify any special handling requirements or precautions.

6. Quality Control Checks:

- Detail the quality control tests to be performed on finished products.

- Include specifications, testing methods, and acceptance criteria.

7. Batch Records Review and Approval: 

- Specify the personnel responsible for preparing, reviewing, and approving the Master Formula Record.

- Include signature lines and dates for each reviewer and approver.

8. References:

- Reference relevant SOPs, specifications, and regulatory guidelines.

- Include any other documents or references used in the preparation of the Master Formula Record.

9. Change Control:

- Describe procedures for updating the Master Formula Record in case of changes.

- Specify the approval process for any modifications to the document.

This template provides a structured format for documenting the Master Formula Record, ensuring that all necessary instructions are clearly outlined for the manufacturing of the pharmaceutical product. Adjustments can be made based on specific product requirements and manufacturing processes.