Definition of the Master Formula Record: A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the. processing instructions, including the in-process controls.”
Master production instructions should include:
- The name of the intermediate/API/formulation being manufactured and an identifying document reference code, if applicable
- A complete list of raw materials and intermediates (designated by names or codes sufficiently specific to identify any special quality characteristics)
- An accurate statement of the quantity or ratio of each raw material or intermediate to be used, including the unit of measure. Where the quantity is not fixed, the calculation for each batch size or rate of production should be included. Variations to quantities should be included wherever justified
- The production location and major production equipment to be used. Detailed production instructions, including the
- Sequences to be followed
- Ranges of process parameters to be used
- The methods, or reference to the methods, to be used for preparing the critical equipment (e.g., cleaning, assembling)
- Sampling instructions and in-process controls, with their acceptance criteria, where appropriate
- Time limits for completion of individual processing steps and/or the total process, where appropriate
- Expected yield ranges at appropriate phases of processing or time.
- Where appropriate, special notations and precautions to be followed, or cross-references to these
- Instructions for storage of the intermediate or API/semi-finished formulations to assure their suitability for use; instructions should cover the labeling (specimen labels and packaging materials and special storage conditions with time limits, where appropriate).
Master Formula Record is also called MFR, Master Production Record. MFR is used as the reference standard for preparing batch manufacturing records (BMR) by manufacturing units… It is prepared by the research and development team of the company. It contains all information about the manufacturing process for the product. Master Formula Record (MFR) is a master document for any pharmaceutical product. MFR plays an important inconsistency in each batch of manufacturing. There shall be Master Formula records relating to all manufacturing procedures for each product and batch size to be manufactured. This shall be prepared and endorsed by the competent technical staff i,e. head of production and quality control. A Master Formula Record is either prepared based upon the experience of competent qualified staff like manufacturing chemist or analytical chemist or prepared based upon batch manufacturing record of batch size.
MFR includes –
- Product Details: Name, logo, and address of the manufacturing company.
- Dosage form name. Brand name, Generic name.
- Product code and Label claim of all ingredients
- Product description: Batch size, Pack size, and packing style
- Shelf life and Storage conditions
- MFR number and date: Supersede MFR number and date,
- Effective batch number
- Authorization by the production and quality assurance head
- Equipment: A list of all required equipment and machines required in the manufacturing process with their capacity.
- Special instructions: The precautions and special instructions to be followed during the product manufacturing and packing Calculations: Include the calculation steps of all active materials to get the 100% of the active material. The calculation is done using water or LOD to get 100% potency.
- Manufacturing Process: All steps in all stages of the manufacturing process are written. All process steps like shifting, milling, lubricating, granulation, compression, and coating are written in detail including the processing time and yield. It also includes atmospheric conditions such as temperature, humidity, and storage conditions for every step.
- Packing Process: A list of all packing materials with their quantity is written. Line clearance and reconciliation of printed and unprinted packing materials should be included in details.
- Yield: Include the theoretical, actual yield, and acceptance limit of the batch.
Primary Responsibility is of F&D and Production Department and secondary responsibility is of Quality Assurance Department. Accountability lies with Head-Quality Assurance for the implementation of SOP.
Steps in preparation for MFR:
Production Department in association with F&D prepares MFR. It is divided into two sections;
The first page of both the sections shall have the following details: Name, address, and logo of the company, Dosage form, Brand name Generic name Product code Label claim: this should include all ingredients and text included in the product permission. Product Description, Shelf Life, Pack Size, Batch Size, and Storage conditions.
The secondary page of the manufacturing section shall include-Process steps to be monitored. Subsequent pages shall include the processes to be monitored. 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 Batch Manufacturing Formula.
At the end of every important stage, include a statement of the yield with the acceptable limits. In-process quality checks during and at the end of important steps and stages with their limits are included. The process shall include the process equipment to be used. The methods or the reference of the methods/procedures employed for preparing, cleaning, assembling, and operating the various equipment are given. Detailed stepwise processing instructions(example: checks on materials, pretreatments, the sequence for adding materials, mixing times, temperatures, humidity, etc.) are included. The requirements for storage conditions of the products are also present.
The secondary page of the packaging section of MFR should include the complete list of all the packaging materials required for standard batch size, including quantities, sizes, and types Include line clearance checking during batch cording and batch packaging operations. Includes reconciliation of printed and unprinted packaging materials with acceptable limits. Includes destruction of excess or rejected printed packaging materials Includes description of packaging operation including any significant subsidiary operations and equipment to be used.
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