SOP on Control of Master Formula Records (MFRs)
Objective : To lay down a procedure for preparation and updating of Master Formula Records (MFRs).
Scope : This Standard Operating Procedure is applicable to Master Formula Records of all the products manufactured or marketed.
Responsibility : Executive/Officer Quality Assurance shall compile, maintain and update the Master Formula Records as per this SOP, Head QA shall ensure compliance of this SOP.
Procedure : The MFR shall be prepared for individual product. MFR file shall contain only current master documents.
Master Formula Record shall contain documents approved by Research and Development, Production, Quality Control and Quality Assurance department and filed as appropriate:
Master copy of Technical Directions (Manufacturing).
Master copy of Technical Directions (Packaging) pack style and markets.
Master copy of Specification/STP for In-Process Release, Finished Goods Release, Finished Goods Shelf life and Finished Goods Stability shall also be filed appropriately.
Approved artwork and Shade Cards.
Master Formula Record shall contain above approved documents providing following information regarding the product:
Patent / proprietary name of the product and its corresponding product code.
Pharmacopoeial / generic name(s) of the product, its composition and strength.
Dosage form and physical characteristics.
Shelf life of the product.
Detailed information of product pack and packaging materials.
Color scheme of printed packaging material
Unique item code number and quantity of all input raw material and packing material including overages.
Stepwise details of the process of manufacture and time taken for critical steps.
Equipment / machinery used for manufacturing the product.
Statement of the expected final yield with the acceptable limits and relevant intermediate yields, where applicable.
Sufficient detail, precautions to be taken during manufacturing.
Reference to SOPs relevant in manufacturing activities.
All analytical procedures, including limits thereof, applicable to the finished product.
A list of Master Formula Records shall be maintained and updated by QA, as and when required.
A form, ‘Details of Master Formula Record’ shall be prepared and maintained as per contents of MFR file. The details shall be entered in this form. This form shall be placed in the beginning of MFR file.
As soon as any content of Master Formula Record is super ceded, each page of its master copy / approved artwork or shade cards shall be stamped ‘OBSOLETE’ / ‘OBSOLETE – FOR REFERENCE ONLY’ and all such copies shall be retained in a product file for a period of not less than seven years from their respective effective dates in the QA department.
Product file shall be product specific and shall contain all the obsolete documents of the MFR file. Product file shall provide the history of the product.
A form ‘Details of Product File’ shall be prepared and updated as per the contents of Product file. This form shall detail the due month and year of destruction of obsolete document.