SOP for Assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number to the Drug Products
Objective : To lay down a procedure for assigning number to Master Formula Card, Master Formula and Packaging Formula of a Drug Product.
Scope : This Standard Operating Procedure is applicable for assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number in the relevant documents i.e. Master Formula Card Number to Master Formula Cards, Master Formula Number to manufacturing TDs for manufacturing procedure and Packaging Formula Number to packaging TDs for packaging procedure for a drug products, which shall be manufactured at the formulation plant.
In case of other locations, the relevant documents shall bear Master Formula Number and Packaging Formula Number as per the procedure defined in SOP. At the time of revision of manufacturing TDs for these locations, the same shall be given Master Formula Number as per the procedure defined in this SOP. In any case, if a manufacturing TD for other locations bears a Master Formula Number as per this SOP, its all related Packaging TDs shall always bear the Packaging Formula Number as per this SOP. At the time of revision of packaging TDs or preparation of new packaging TDs for these locations, the TDs shall be given Packaging Formula Number corresponding to the Master Formula card Number applicable for that location. For instance, if a new packaging TD is prepared or the existing packaging TD is revised for the packing of a product manufactured with manufacturing TDs bearing Master Formula Number as per the procedure discussed in SOP, such packaging TD shall bear the Packaging Formula Number as defined in this SOP, else the packaging TDs shall be given new Packaging Formula Number as per the procedure discussed in this SOP.
Responsibility :
Scientist, Documentation Cell (R&D) shall be responsible for assigning Master Formula Card Number in the Master Formula Cards.
Scientists, Process Development shall be responsible for assigning Master Formula Number in the Technical Directions (manufacturing procedure).
Scientist, Packaging Development shall be responsible for assigning Packaging Formula Number in the Technical Directions (packaging procedure).
Abbreviations and Definitions
Master Formula Card Number: This number shall be allotted to the controlled document called Master Formula Card enclosing formulae and procedure in brief for the manufacturing and packaging of the product. This document shall be implemented at the time of technology transfer of manufacturing process from R&D to the manufacturing location.
Master Formula Number: This number shall be allotted to the TDs detailing manufacturing procedure.
Packaging Formula Number: This number shall be allotted to the TDs detailing packaging procedure.
TDs: Technical Directions
Procedure :
Assigning Master Formula Card Number
Master Formula Card Number shall be of six or seven numeric characters.
First and (Second character in case if location code is 10 till 99) shall be numeric code (shall be termed as plant code) denoting manufacturing location. For Goa manufacturing location the code shall be ‘1’ and for Baddi location it shall always be ‘2’. Similarly for other locations including contract manufacturing locations the codes can be given from 3 onwards up to 99. For e.g. if ‘X’ is the 10th location, then Location code given to it is 10.
Second, Third and four characters (or Third, fourth & fifth character) shall be the unique numeric product identity characters to be assigned to the product as per SOP titled ‘Assigning Item Codes to Raw Materials, Packaging Materials, In-process Materials and Finished Products’.
Last two characters i.e. fifth & sixth (or sixth & seventh) shall represent the revision level of the Master Formula Card (i.e. starting from 00 to 99)
E.g. Master Formula Card Number for the Master Formula Card for Nimesulide tablets 100 mg) with 015 three unique product identity characters, prepared first time for Goa location, shall be 201500 and first revision of the Master Formula Card shall reflect Master Formula Card Number as 201501 whereas for location code 20 location then Master formula card number shall be 2001500 for that location prepared for the first time and first revision of Master formula card number as 2001501.
Assigning Master Formula Number :
All Technical Directions detailing manufacturing procedure shall be given eight or nine alphanumeric characters
First four (or five characters in case of location code is 10 and so on till 99) of the Master Formula Number shall always be the first four or five characters of the Master Formula Card Number .
Fifth (or Sixth character) shall be an alphabet starting from ‘A’ and shall denote the batch size.
Sixth (or Seventh) character shall be ‘–’ (dash)
Last two characters i.e. seventh & eight (or eight & ninth) shall represent the revision level of the Technical Directions (i.e. starting from 00 to 99)
e.g. Master Formula Number for the Technical Directions (manufacturing procedure) for Nimesulide tablets 100 mg with 015 three unique product identity characters, prepared first time for Goa location with one batch size, shall be 2015A-00 and first revision of the same Technical Directions shall reflect Master Formula Number as 2015A-01. whereas Master formula number for technical directions ( manufacturing procedure) for Nimesulide tablets 100 mg with 015 three unique product identity characters, prepared first time for 10th location( whenever applicable) and so on with one batch size, shall be 10015A-00 Similarly for the subsequent batch sizes, the relevant Technical Directions (first versions) shall bear Master Formula Number as 2015B-00, 2015C-00, 2015D-00 for Baddi Location and Master formula number as 10015B-00,10015C-00,10015D-00 for 10th location(whenever its applicable).
Assigning Packaging Formula Number :
All Technical Directions detailing packaging procedure shall be given twelve or thirteen alphanumeric characters.
First four (or five characters) of the Packaging Formula Number shall always be the first four or five characters of the Master Formula Card Number
Fifth & sixth (or sixth and seventh) characters shall be the serial number of packaging formula number (Technical Directions) starting from 01 to 99 i.e. a product manufactured with one Master Formula Number can be packed in different pack sizes so different TDs (packaging procedures) bearing different packaging formula numbers (Serial number) shall be prepared.
Seventh (or eight character) shall denote the supply as given below:
‘S’ shall denote product for Sale
‘P’ shall denote Physician sample
‘C’ shall denote product for Clinical Trial
‘G’ shall denote product for Government Supply
Eight & nine (or Nineth & tenth characters) shall be market codes, for more details refer SOP titled ‘Assigning Item Codes to Raw Materials, Packaging Materials, In-process Materials and Finished Products’ , defining procedure for assigning the item codes to Finished Products.
Tenth (or Eleventh character) shall be ‘–’ (dash)
Last two characters i.e. eleventh & twelveth (or twelfth & thirteen) shall represent the revision level of the Technical Directions (i.e. starting from 00 to 99)
e.g. First Packaging Formula Number for the first version of Technical Directions (packaging procedure) for Nimesulide tablets 100 mg for Baddi location to be prepared against the Technical Directions with manufacturing formula number 2015A-00 (or for its subsequent revisions, as applicable), for sale in the domestic market, shall be 201501S00-00. Similarly for other pack sizes, the relevant Technical Directions (first versions) shall bear Packaging Formula Number as 201502S00-00, 201503S00-00 and so on, for sale of the product in the domestic market.
Documentation Cell (R&D) shall maintain the list of all Master Formula Cards.
Process Development Department shall maintain the list of all TDs detailing manufacturing procedure.
Packaging Development Department shall maintain the list of all TDs detailing packaging procedure.
Note: Documentation cell R&D shall update list of Site location of Pharmaceutical products Whenever there is addition of new Location site and shall send a copy of same to QA for there reference.