Master formula record

Learn about master formula record one of the required document in regulatory process of product

1. Master formula record (MFR) Presented by. Pranali.M. Palandurkar

2. MFR is master document for any pharmaceutical product MFR contain all information about the manufacturing process for the product It is prepared by research & development team of the company. It is also called master manufacturing record, master production record. It is used as reference standard for preparing batch manufacturing record by manufacturing units

3. Definition "A document or set of document specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in -process controls."

4. MFR should include 1 . Product Details : Name, logo and address of the manufacturing company. Dosage form name Brand name Generic name Product code Label claim of all ingredients Product description Batch size Pack size and packing style Shelf life Storage conditions MFR number and date Effective batch number Authorization by the production and quality assurance he ad .

5. 2. Flow Chart : Steps of the manufacturing process to be monitored. Flow chart of the material movement from dispensing to the final product to stores . 3. Equipments : Create a list of all required equipments and machines required in the manufacturing process with their capacity . 4. Special instructions : Write down the precautions special instructions to follow during the product manufacturing and packing .

6. 5. Calculations : Include the calculation steps of all active materials to get the 100% of the active material. 6 . Manufacturing Process : Write all ste p in a ll stages of the manufacturing process. All process steps should be written in detail including the process time and yield. Include atmospheric conditions as temperature, humidity and storage conditions for every step . 7. Packing Process : List of all packing materials with their quantity is written. Line clearance, reconciliation of printed and unprinted packing materials should be included in details. 8. Yield : Include the theoretical, actual yield and acceptance limit of the batch.

7. Steps to prepare a master formula record Production department in association with F&D , shall prepare MFR. MFR shall prepared as per the format attached with SOP MFR shall be divided into two parts Packaging part Manufacturing part

8. The first page of both the section shall have complete product detail along with Drug schedule : whether schedule H or schedule G drug Superseded master card number& date Present master card number & date Present master card effective batch number Reference of changed control number

9. The secondary page of manufacturing section shall include process to be monitored . Subsequent pages shall include the process to be monitored. The stage wise movement of material in a form of flow chart. T he list of equipment ,machines, apparatus to be used, shall be described. The subsequent page shall include any special precautions to be taken for the product during manufacturing and packaging .

10. The same page should also include batch manufacturing formula. Batch formula should have the following columns. Serial number Name of ingredients Reference of specification of ingredients Quantity to be added Overages to be added (in %) Quantity to added per batch or per lot

11. At the end of every important stage, include a statement of yield with the acceptable limits. Include in-process quality checks during and at the end of important steps and stages with their limits. The process shall include t he process equipment to be used. The method or the reference of the method/ procedure to employed for preparing, cleaning, assembling operating the various equipment shall be given. I nclude the requirements for storage conditions of the product.

12. The packaging part of MFR should include complete list of all the packaging material required for a standard batch size, including quantities ,sizes& types . Include line clearance checking during batch coding and batch packaging operations. Include reconciliation of printed and imprinted packaging materials with acceptable limits. Includes description of packaging operation including any significant subsidiary operations and equipment to be used.

13. SOP for preparation of MFR Responsible department Primary responsibility Secondary responsibility F&D and production Quality assurance department department Accountability : Head –quality assurance shall be responsible for implementation of SOP

14. THANK YOU...