SOP For Preparation of Master Formula Record

SOP For preparation of master formula record is described in this post which you can follow in the section of the Quality Assurance Department.

Objective

To describe the procedure for preparation of Master Formula Record.

Scope

This SOP applies to the preparation of Master Formula Record.

Responsibility

Production Pharmacist

Quality Assurance Officer

Accountability

Production Pharmacist

Manager Quality Control

Manager Quality Assurance

Procedure

Production Department in association with F&D, shall prepare Master Formula Record (MFR).

Master Formula Record (MFR) shall be divided into two parts 

  • Manufacturing part
  • Packaging part.

The first page of both the sections shall have following details:

  • Name, Address and Logo of the Company.
  • Dosage Form.
  • Brand Name.
  • Generic Name.
  • Product Code.
  • Label claim.
  • Product description.
  • Batch Size.
  • Pack size
  • Shelf life
  • Storage condition
  • Drug schedule: Whether schedule "H" or schedule "G" drug.
  • Superseded Master Card No. and date.
  • Present Master Card No. and date.
  • Present Master Card effective B. No.
  • Reference of change control number.

There shall be authorization on all pages of Master Formula Record (MFR) by three persons 

  • Production Pharmacist 
  • Production Manager
  • Quality Assurance Manager 

All the 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 manufacturing section shall include:

  • Subsequent pages shall include the processes to be monitored. 
  • The stage-wise movement of the material in a form of 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, 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. 
The batch formula should have following columns:

  • Serial number.
  • Name of ingredients.
  • Reference of the specification of ingredients.
  • Quantity to be added.
  • Overages to be added (in %).
  • Quantity to be added per batch or per lot.
  • 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.
  • Written process stage wise and stepwise. At the end of every important stage, calculate yield with acceptable limits.
  • In-process quality checks at every important step with their limits.
  • The process shall include the process equipment's, methods or the reference of the methods/ procedures to be employed for preparing, cleaning, assembling, operating the various equipment shall be given.
  1. Detailed stepwise processing instructions
  2. checks on materials, 
  3. Pretreatments, 
  4. The sequence for adding materials, 
  5. Mixing times, 
  6. Temperatures and humidity etc.

  • Requirements for storage conditions of the products.

The packing part of Master Formula Record (MFR) should include 

  • A complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types.
  • Line clearance checking during batch coding and batch packing operations.
  • Reconciliation of printed and unprinted packing materials with acceptable limits.
  • Destruction of excess or rejected printed packing materials.
  • Description of packaging operation including any significant subsidiary operations and equipment to be used. 
  • Details of in-process controls with instructions for sampling and acceptance limits.
  • Reconciliation of the packing yield with acceptable limits.
  • Finally include batch release procedure.

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