SOP for Preparation of Master Formula Record (MFR)

Objective

To describe the procedure for preparation of Master Formula Record.

Scope

This SOP applies to the preparation of the Master Formula Record.

Responsibility

Primary Responsibility: F&D and Production Department

Secondary Responsibility: Quality Assurance Department

Head- Quality Assurance shall be accountable for the implementation of the SOP.

Procedure

• The production Department in association with F&D shall prepare Master Formula Record (MFR).
• Master Formula Record (MFR) shall be prepared as per the format attached to this SOP.
• Master Formula Record (MFR) shall be divided into two parts as shown in the attached Format - the Manufacturing part and the Packaging part.
• The first page of both sections shall have the following details:

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1. Name, Address, and Logo of the Company.
2. Dosage Form
3. Brand Name
4. Generic Name
5. Product Code
6. Label claim: This should include all ingredients and text included in product permission.
7. Product Description
8. Batch Size
9. Pack size: This should describe the packing style of the salable pack and sample pack. This should be expressed in terms of the number, weight or volume of the product in the final container.
10. Shelf life:
11. Storage condition
12. Drug schedule: Whether schedule "H" or schedule "G" drug.
13. Superseded Master Card No. and date
14. Present Master Card No. and date
15. Present Master Card effective B. No.
16. Reference of change control number

• There shall be authorization on all pages of the Master Formula Record (MFR) by three persons i.e. the person who shall prepare the Master Formula Record (Production Officer), the person who shall check the Master Formula Record (Production Head), and the person who shall finally approve(Quality Assurance Head) it. All three persons will sign off all the pages. Their designation and their name will be printed below their signatures along with the date of signing the document.
• The second page of the manufacturing section shall include the process steps to be monitored.
• Subsequent pages shall include the processes to be monitored. The stage-wise movement of the material in the form of a flowchart. The flow chart shall cover all activities beginning from the dispensing of the materials and ending at the transfer of a batch to finished stores.
• The list of equipment, machines, and utensils to be used, shall be described.

• The subsequent page shall include any special precautions to be taken for the product during manufacturing and packing. The same page should also include the Batch Manufacturing Formula. The batch formula should have the following columns:

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1. Serial number
2. Name of ingredients
3. Reference of the specification of ingredients
4. Quantity to be added (in mg per ml or per tablet or per capsule or per gram as the case may be)
5. Overages to be added (in %)
6. Quantity to be added per batch or per lot

• Below are the calculation steps for every active material, ensuring that the active materials shall be compensated for assay values less than 100 % which could be due to less potency or higher moisture content.
• In the subsequent page, including the manufacturing process. Write the process stage-wise and stepwise. At the end of every important stage, include a statement of the yield with acceptable limits.
• Include in-process quality checks during and at the end of important steps and stages with their limits.
• The process shall include the process equipment to be used. The methods or the reference of the methods/ procedures to be employed for preparing, cleaning, assembling, and operating the various equipment shall be given.
• Include detailed stepwise processing instructions (e.g. checks on materials, pretreatments, the sequence for adding materials, mixing times, temperatures, humidity, etc.).
• Include the requirements for storage conditions of the products.
• The packing part of the Master Formula Record (MFR) should include a complete list of all the packaging materials required for standard batch size, including quantities, sizes, and types.
• Include line clearance checking during batch coding and batch packing operations.

• Include reconciliation of printed and unprinted packing materials with acceptable limits.
• Include destruction of excess or rejected printed packing materials.
• Include a description of packaging operation including any significant subsidiary operations and equipment to be used. Include details of in-process controls with instructions for sampling and acceptance limits.
• Include reconciliation of the packing yield with acceptable limits.
• Finally include batch release procedure.

Abbreviations

QA: Quality Assurance

SOP: Standard Operating Procedure

No.: Number

e.g.: Example

Revision History

Nil

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