1 / 10

Yash MFR

Master Formula Record

Chandrashekhar3
Download Presentation

Yash MFR

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY, DEORI SUBJECT – Quality Assurance TOPIC- Master Formula Record PRESENTED BY – Yash G , Baishnab CLASS- B.Pharm 3rd year (6 sem) Guided by – Badwaik Sir

  2. Master Formula Record ⏺️⏺️⏺️ • Master Formula Record (MFR) is a master document for any pharmaceutical product which contains all information about the manufacturing process of the product. MFR is prepared by the research and development team of the company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units. MFR is also called Master Manufacturing Record, Master Production Record.

  3. Defination ⏺️⏺️⏺️ • A document or set of documentes specifying the starting materials with their quantities and packaging material 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 process controls. ⏺️There shall be Master Formula records relating to all manufacturing procedures for each product and batch size to be manufactured. These shall be prepared and endorsed by the competent technical staff And head of production and quality control. ➤ MFR plays an important role in consistency for each batch manufacturing.

  4. MFR SHOULD INCLUDE ⏺️⏺️⏺️ ⏺️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. ⏺️Supersede MFR number and date. ⏺️Effective batch number. ⏺️Authorization by the production and quality assurance head. • PRODUCT DETAILS :

  5. EQUIPMENT: Enlist all required equipment and machines in the manufacturing process along with their capacity. SPECIAL INSTRUCTIONS: All the special instructions for the manufacturing of product and packing should be noted and included in the batch manufacturing formula. • CALCULATIONS: Include the calculation steps of all active materials to get the 100% of the Active Material MANUFACTURING Process: All the steps like shifting, milling, lubricating, granulation, compression, coating, process time and yield which are involved in the manufacturing process should be written in details. The details of atmospheric conditions as temperature, humidity, and storage conditions for every step should also be written. • PACKING PROCESS: The packing materials along with quantity should be written. YIELD: nclude the theoretical, actual yield and acceptance limit of the batch.

  6. ⏺️PROCEDURE TO PREPARE A MASTER FORMULA • RECORD: A Master Formula Record is either prepared based upon experience of competent qualified staff like manufacturing chemist or analytical chemist or prepared based batch manufacturing record of a batch size. Upon Master formula record cannot be ignored at any level. Once Master Formula Record is prepared, it is transferred to previous staff to new staff. It is followed as standard documents for processing a batch. Master Formula record is considered as standard for making a Batch Manufacturing Record. ⏺️SOP for preparation of the Master Formula Record: Responsible departments: ⏺️Primary Responsibility: Fand D and Production Department. ⏺️Secondary Responsibility: Quality Assurance Department. ⏺️Accountability: Head-Quality Assurance shall be responsible for implementation of SOP.

  7. ⏺️STEPS TO PREPARE A MASTER FORMULA RECORD • Production department in association with formulation and development prepare MFR and it should be prepared as per the format attached with the SOP. MFR IS DIVIDED INTO TWO PARTS: • 1) Manufacturing Part . • 2) Packaging PART . • The first page of packaging and manufacturing sections shall have following details: Name, address and logo of the company Dosage form. Brand name. Generic name. Product code. Label claim of all ingredients

  8. ⏺️LABEL CLAIM : It include all ingredients and text included in product permission: • Product Description. Batch Size. Pack Size. Shelf Life. Storage conditions. Drug Schedule: whether schedule H or schedule G drug. Superseded Master card number and Date.

  9. ⏺️Batch Formula should have the following columns: • Serial number. • Name of ingredients. Reference of specifications of ingredients. . Quantity to be added (in mg/ml or per tablet or per capsule or per gm, as the case may be. Overages to be added (in %). • Quantity to be added per batch or per lot. At the end of every important stage, include a statement of the 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 the process equipment to be used.

  10. REF BY : DR RANDHIR SINGH DAHIYA (NIRALI PRAKASHAN)

More Related