Standard Operating Procedure for Preparation of Master Formula Record (MFR)

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Standard Operating Procedure for Preparation of Master Formula Record (MFR)

Standard Operating Procedure for Preparation of Master Formula Record (MFR)

1. Purpose

To provide guidelines for preparation of Master Formula (MF)

2. Scope

This procedure is applicable to the preparation of MF of all products manufactured at [company name].

3. Responsibility

Quality Assurance Head – Approval of MFR. To ensure complaince

QA Person – Preparation and and review of MFR

Manufacturing Head – REview of MFR

4. Definitions

Not Applicable

5. Procedure

  1. Introduction of any new product, change in process, equipment or batch size, in the plant calls for preparation of Master Formula.
  2. For a new product, MFR shall be prepared by QA based on the Technology Transfer document received from R&D department or Corporate QA .
  3. MFR shall be Approved by Head QA.
  4. A document number shall be assigned to the MF which shall be in the form of MFR-XX, X is three digit serial number i.e. 001, 002, 003,0004 ……
  5. A Master list of MFR shall be maintained by Manager QA and shall have the following details :

Name of the Product
Master Formula number
Revision Number
Effective date

  1. The Master Formula shall be printed on A4 paper, the style of the text shall be “Times New Roman” and the font size shall be “11”.
  2. The Header of all pages of Master Formula shall have logo of [Company Name] at the top on the right side.
  3. A table with, Product name & Generic name of the product shall follow the header on the left side and Master Formula no., Revision number & page number on the right side.
  4. The Product name and Generic name of the product shall be written on the first page of the Master formula
  5. A “Revision number” shall be assigned to each Master Formula, indicating the number of revisions the document has undergone. The number shall be “0”, when the document is prepared for the first time and shall be assigned numbers serially as 1, 2…. for subsequent revisions.
  6. An “Issue date” indicating the date of issue, shall be mentioned in the Master formula.
  7. An “Effective date” shall be mentioned on the Master Formula. This is the date on which the Master formula comes into effect. This shall appear only on the first page.
  8. “Next Review month” shall be mentioned on the Master Formula indicating the month in which the Master Formula is due for reviewing. This shall appear only on the first page. This shall be the 2 years from the date of issue.
  9. A “ Page number” is assigned to each page of the Master Formula. The page number shall be in the form of 1 of X, 2 of X,…..X of X, where X= total no. of pages.
  10. “A Copy number” shall be assigned to each copy of the Master Formula.
  11. “ Reason for revision” shall be stated on the first page of the Master Formula. When the Master Formula is prepared for the first time, the reason for revision shall be stated as “First Edition”.
  12. The Master Formula shall have the following details:
    a) Content
    b) Product Information
    c) Formulation Order
    d) Packaging Order (Sales & Physician samples)
    e) List of equipment used in manufacturing & packaging
    f) Instruction & precautions to be taken during manufacturing & storage
    g) Manufacturing instruction along with control parameters of critical processes
    h) Yield Statements
    i) Testing and release of semi-finish and Finished products
    j) List of Testing specifications of raw materials
    k) List of Testing specifications of packaging materials
    l) Approved specimen samples of all printed packaging materials
  13. Content: This page shall have the description of the contents of Master Formula & the respective page numbers, serially.
  14. Product Information: This page shall include the following information in sequence
    a) Product name
    b) Generic name
    c) Product codes
    d) Dosage form (Tablets / Capsules)
    e) Label Claim
    f) Molecular weight of active ingredient
    g) Therapeutic category
    h) Shelf life
    i) Storage condition
    j) Manufacturing Location
    k) Manufacturing License Number
    l) Batch Size
    m) Pack profile (Sale / Physician Sample)n)
  15. Formulation Order: The Formulation order shall specify serially the raw materials, its respective item code, Pharmacopoeia standards, Quantity per tablet, overages and quantities for the specified batch size. It shall also specify calculations for potency of active ingredients, if any.
  16. Packaging order: The packaging order shall specify serially the packaging materials, its respective item codes and quantities for specified batch size.
  17. List of equipment used in manufacturing & packaging: This list shall include the equipment used for manufacturing & packaging of the product, it’s respective code number, Make, Capacity / dimensions, Reference SOP number for Cleaning & Operation.
  18. Instruction & precautions to be taken during manufacturing and Storage: General & specific manufacturing and storage conditions to be followed during the manufacturing & packaging shall be specified.
  19. Manufacturing instructions along with control parameters for critical process: A detailed procedure for manufacturing & packaging shall be specified along with critical process control parameters. The limits set for each stage of the process shall also be specified.
  20. Yield Statement: This page shall include the stages of manufacturing & packaging and their respective permissible yield range in kg and Nos.
  21. Testing & release of semi-finish and Finished product: This page shall include the following information:
    a) The description of the test to be performed
    b) Reference SOP number for sampling
    c) Reference SOP number for testing
    d) Testing Specification No.
    e) Responsibility
  22. Testing Specification of Raw material This shall include the description of the raw materials, Standards and Testing specification number.
  23. Testing Specification of Packaging material (Sale & PS) This shall include the description of the packaging materials and Testing specification number.
  24. Approved specimen samples of printed packaging material: The approved specimen samples of printed packaging material shall be kept as reference.
  25. All approved Master Formula shall be stamped as “MASTER COPY” in green ink, on the bottom right hand side of all the pages.
  26. When a Master Formula is revised, Manager QA shall retrieve the superceded copies. The retrieved copies shall be destroyed and Copy number 1 shall be stamped as “OBSOLETE COPY” in red ink on all pages and be retained by Manager QA for future reference.
  27. The issue & retrieval of Master Formula shall be recorded in a logbook.
  28. Any change to be effected in the Master Formula, shall be made through a Change Control as per the SOP for Change Control. The Master Formula shall be issued to respective personnel as per the Distribution List.

Frequency

New product introduction.
Any change in the formula.

Format for recording

Sr. No.
Document
Ref. No.
Rev. No.
Effective date
Effective Batch No.
Reason for revision
Superseded copy retrieved and destroyed by/date
Checked by/date

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