MFR Master Formulation Record | Preparation Guide
Procedure:
MFR Master Formulation Record | Preparation Guide:On the basis of data collected during successful development, Master Formula Record (MFR) shall be prepared by concerned Research Associate / Development Scientist. Master Formula Record (MFR) shall be prepared of every new product of FRD.
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Master Formula record shall have four parts as Cover Page, Header part, Footer part and Body text.
Cover Page: MFR Master Formulation Record
· Cover Page shall contain Company address.
· Company name shall be written below address and MASTER FORMULA RECORD along with Product Name (Brand name & Generic name).
· Cover Page shall also consist three rows, whereas first and second rows shall have two columns and third row shall have no column.
· First column of the first row shall contain heading as “MFR No” and second column of first row shall contain heading as “Issue Date.
· First column of the second row shall contain heading as “Supersedes No” and second column of second row shall contain heading as “Effective Date”.
· Third row shall contain heading as “Reason for Revision”.
Header Part: MFR Master Formulation Record
· Header part shall be common for all pages other than Cover Page of Master Formula Record.
· Header Part of the Master Formula Record shall consist eight rows. Whereas third and fourth row shall have two columns and fifth to eighth row shall have four columns.
· Header Part of master formula shall consist following details:
· Company Logo & Name: The first row shall contain company logo and Company name as per SOP
· Master Formula Record: Centre of the second row shall contain “Master Formula Record”.
· Product Name: First column of the third row shall contain heading as “Product Name. In case the Brand Name is not available, MFR may be prepared with generic name in such case the Product Name (Brand Name) shall be written as “Not Applicable”, which means product brand name is not available at the time of MFR preparation.
· Generic Name: First column of the fourth row shall contain heading as “Generic Name”
· MFR Number: First column of the fifth row shall contain heading as “MFR Number”:
· First Three alphabets i.e. “MFR” denotes abbreviated form of Master Formula Record.
Pharmacopoeia Status: First column of the sixth row shall contain heading as “Pharmacopoeial Status”: MFR Master Formulation Record
Pack: Second column of the sixth row shall contain heading as “Pack
Batch Size: First column of the seventh row shall contain heading as “Batch Size
Effective Date: Second column of the seventh row shall contain heading as “Effective Date
Issue Date: First column of the eighth row shall contain heading as “Issue Date
Footer Part:
Each page at the footer bears the space to the details for Prepared by, checked by and Approved by with the Name, Designation, Signature & Date
Body Part:
General Information: The Second Page shall contain the details in sequence Like
· Label Claim
· Shelf Life
· Storage Condition
· Direction for Uses/Dosage, If Any
· Therapeutic Category & Indication, If Any
· Cautions/Warning, If Any
· Market (Domestic/Export)
· Manufactured By
· Marketed By
· Standard Batch Size
· Minimum Batch Size
· Maximum Batch Size
MFR Master Formulation Record :The second page onward master formula shall contain following contains but not limited to these:
Bill of Raw Material: This section shall cover list of the raw materials to be used, with the amount of each RM, Item code, reference Pharmacopoeial specification, Unit of measurement
•Calculation.
•Overages, if any.
· Functional Category & Vendor Detail (Manufacturer Name): This section shall contain approved vendor name along with functional Category of each RM.
· Equipment List: This section shall contain statement of the processing location and the principal equipment along with their capacity to be used during manufacturing of finished products.
· Safety Instructions/Precautions: Safety precautions/instruction and uses of personal protective equipment during dispensing, in-process and finished products. If Any
· Critical Control care of Points, If Any
· Process Flow Chart
· Manufacturing Instructions and Process: Detailed step-wise processing instructions (e.g. checks on materials, pretreatments, sequence for adding materials, mixing time, temperatures and other process parameter with their acceptance limit etc.); Environmental condition to be manufactured during manufacturing, storage and packing operation of drug product. Step-wise details of in-process controls with instructions for sampling and acceptance limits
· Pack Profile and Change Part Details:
· Packaging Instructions: Instruction to be maintained during primary packing shall be covered under this section. If Any
· Pack Profile shall be taken from packaging dept. after finalization from Customer (Marketed by).
· All details related to tooling / change part shall also be covered in this section.
· Abbreviations: This section shall cover expended form of abbreviation used in master formula record.
· Change History: Change history of master formula record shall be maintained at the end of Master Formula Record
MFR Master Formulation Record Format /Template|
[Product Name]
Label Claim : Shelf Life Storage Condition : Direction for Uses/Dosage: Therapeutic Category (If any): Indication (If any) : Cautions/Warning (If any): Market (Domestic/Export): Manufactured By : Marketed By : Standard Batch Size : Minimum Batch Size : Maximum Batch Size : · Bill of Raw Material : · Approved Vendor Detail : · Equipment/ Instrument List : · Critical Control Care Points: · Process Flow Chart : · Manufacturing Instructions : and Process · In Process Parameters : · Packaging Instructions : · Abbreviation : · Change History :
Check List for Technology Transfer of Manufacturing Process History of Change
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