MASTER FORMULA RECORD

1.0 Objective: To describe the procedure for preparation of Master Formula

Record.
2.0 Scope: This SOP applies to preparation of Master Formula Record.
3.0 Responsibility:
3.1 Primary Responsibility
F&D and Production Department
3.2 Secondary Responsibility
Quality Assurance Department
4.0 Accountability: Head- Quality Assurance shall be accountable for
implementation of SOP.
5.0 Procedure:
5.1 Production Department in association with F&D, shall prepare Master Formula
Record (MFR).
5.2 Master Formula Record (MFR) shall be prepared as per the format attached
with this SOP.
5.3 Master Formula Record (MFR) shall be divided into two parts as shown in the
attached Format - Manufacturing part and Packaging part.
5.4 The first page of both the sections shall have following details:
5.4.1 Name, Address and Logo of the Company.
5.4.2 Dosage Form:
5.4.3 Brand Name:
5.4.4 Generic Name:
5.4.5 Product Code:
5.4.6 Label claim: This should include all ingredients and text included in product
permission.
5.4.7 Product description:
5.4.8 Batch Size:
5.4.9 Pack size: This should describe the packing style of salable pack and sample
pack. This should be expressed in terms of the number, weight or volume of the
product in final container.
5.4.10 Shelf life:
5.4.11 Storage condition:
5.4.12 Drug schedule: Whether schedule "H" or schedule "G" drug.
5.4.13 Superseded Master Card No. and date:
5.4.14 Present Master Card No. and date:
5.4.15 Present Master Card effective B. No.:
5.4.16 Reference of change control number:
5.5 There shall be authorization on all pages of Master Formula Record (MFR) by
three persons i.e. person who shall prepared the Master Formula Record
(Production Officer), person who shall check the Master Formula Record
(Production Head) and the person who shall finally approve (Quality Assurance
Head) it. 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.
5.6 The second page of manufacturing section shall include - Process steps to be
monitored.
5.7 Subsequent pages shall include the processes to be monitored. The stage wise
movement of the material in a form of flow chart. 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.
5.8 The list of equipments, machines, utensils to be used, shall be described.
5.9 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 :
5.9.1 Serial number
5.9.2 Name of ingredients
5.9.3 Reference of specification of ingredients
5.9.4 Quantity to be added (in mg per ml or per tablet or per capsule or per gram as
the case may be)
5.9.5 Overages to be added (in %)
5.9.6 Quantity to be added per batch or per lot
5.10 Below that give the 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.
5.11 In subsequent page, include manufacturing process. Write the process stage
wise and stepwise. At the end of every important stage, include a statement of the
yield with acceptable limits.
5.12 Include in-process quality checks during and at the end of important steps and
stages with their limits.
5.13 The process shall include the process equipments to be used. The methods or
the reference of the methods / procedures to be employed for preparing, cleaning,
assembling, operating the various equipments shall be given.
5.14 Include detailed stepwise processing instructions (e.g. checks on materials,
pretreatments, sequence for adding materials, mixing times, temperatures,
humidity etc.).
5.15 Include the requirements for storage conditions of the products.
5.16 The packing part of Master Formula Record (MFR) should include complete
list of all the packaging materials required for a standard batch size, including
quantities, sizes and types.
5.17 Include line clearance checking during batch coding and batch packing
operations.
5.18 Include reconciliation of printed and unprinted packing materials with
acceptable limits.
5.19 Include destruction of excess or rejected printed packing materials.
5.20 Include description of packaging operation including any significant
subsidiary operations and equipments to be used. Include details of in-process
controls with instructions for sampling and acceptance limits.
5.21 Include reconciliation of the packing yield with acceptable limits.
5.22 Finally include batch release procedure.
6.0 Abbreviations:
6.1 QA: Quality Assurance
6.2 SOP: Standard Operating Procedure
6.3 No.: Number
6.4 e.g.: Example