Batch Numbering, Purpose :
Batch Numbering, The purpose of this SOP is to describe the procedure of batch numbering system of finished product and issuing code number of raw, packaging and finished product.
Batch Numbering, Scope :
This procedure is applicable for coding of all raw materials, packaging materials, finished products and batch numbering system of finished product at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]Batch Number: A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.
[][]Code Number: An arrangement of numbers providing a unique identity to the items which they are assigned.
Responsibilities:
[][]The roles and responsibility is as follows:
Executive/ Manager, Product Development
[][]To inform and request Supply Chain department that the new materials to be used for product development.
Executive/ Manager, Supply Chain
[][]Issue the unique material code number of each raw material and packaging materials and as well as finished product
Executive/ Manager, PMD
[][]To inform and request Supply Chain Department to issue material & product code for new products.
Executive/ Manager, Quality Control
[][]Implementation of the total coding system.
Executive/ Manager, Quality Assurance
[][]Implementation of the total coding and batch numbering system.
Executive/ Manager, Production
[][]Implementation of the total coding and batch numbering system
Manager, Quality Assurance
[][]Approval of the SOP.
[][]To ensure that the implementation of the system as per SOP.
Procedure:
Raw Material Coding System:
[][]Maintain seven alphanumerical characters (first three characters are alphabetic and last four characters are numerical) for Raw Material Coding System.
[][]Start the coding with ‘RM’ which stands for ‘Raw Material’ and it is common for every raw material coding system
[][]For the Active Raw Material select ‘A’ as the third character of the code. When the raw material is excipient then select ‘E’ instead of ‘A’.
[][]At last specify the code number with four numerical characters to indicate the separate material. Following this procedure, raw material code for the first enlisted Active Material (API) will be RMA0001 and the second one (API) will be RMA0002.
[][]When the same material has different categories (such as compacted, granular, pharma grade etc.) then for every category, a new code number will be generated maintaining previous procedures.
[][]For example: Raw Material Code Number ‘RMA0001’ stands for
RM=Raw Material
A=Active (In case of Excipient it will be ‘E’)
0001=Individual number of raw material
Packaging Material Coding System:
[][]Maintain seven alphanumerical characters (first four characters are Alphabetic and last three characters are numerical) for Packaging Material Coding System.
[][]First characters which stands for packaging material. Second character will be changed for primary and secondary packaging material, When primary packaging material it will be ‘P’ and when secondary packaging material it will be ‘S’.
For example
=>PP= Primary Packaging Material
=>PS= Secondary Packaging Material
[][]Next two characters which stand for sub category of packaging material. It will be changed for every sub category of packaging material as Annexure-I.
[][]Last three characters which stand for sequential number. Every sub category material starts with sequential number 001. Such as
=>AB-001= Alu- Bottom foil
=>TF-001= Alu-Lid foil
=>And so on
[][]The sequential number will be changed when different types of materials come in same sub category. For example
=>AB-001= Alu –Bottom foil 206 mm
=>AB-002= Alu –Bottom foil 183 mm
=>And so on
[][]Finally the coding system of packaging material is like
=>PP-AB-001
Where
=>PP stands for primary packaging material
=>AB-001 stands for alu bottom foil 206 mm
Finished Product Coding System:
[][]Maintain seven alphanumerical characters (first digit is alphabetic and last five digits are numerical) for finished product coding system.
[][]Start the coding with ‘P’ which stands for finished product. P is common for every finished product code numbering system.
[][]The last five digits 00001 is sequential number. It will be changed in every finished product coding system. It will be also changed when same product in different strength. For example finished product code of Cexoral 200 capsule is P-00001 and Cexoral 400 capsule is P-00002.
[][]Finally the finished product coding system is P-00001
[][]Where P stands for finished product
[][]is dash
[][]00001 stands for sequential number of individual product with strength.
Batch Numbering System for Finished Product:
[][]Maintain six characters (All six digits are numerical) for batch numbering system.
[][]First two digits stand for year. It will be changed for next year.
[][]For example
=>20AA for AA
=>20BB for BB
=>20CC for CC
And so on..
[][]The last four digits are yearly batch requisition serial number of products manufactured in XX Pharmaceutical Limited, Which (last four digits) will be started from 0001, next batch requisition serial will be started from 0002 and so on.
[][]In every new year, the last four digits (batch requisition serial number) will be started from 0001.
[][]Example for presentation of the Product Batch Number on the Inner Carton, Sample Pack, Label and Shipping Carton:
XX0001
Where
XX stands for year of 20XX
0001 sands for serial number of batch manufactured in year of 20XX.
Batch Numbering System for Water for Injection:
[][]Maintain six characters (six digits are alphanumerical) for batch numbering system.
[][]First digit stands for water for injection
[][]Second and third digits stand for year. It will be changed for next year.
For example
20AA for AA
20BB for BB
20CC for CC
And so on…
[][]The last three digits are yearly batch requisition serial number of water for injection which (last three digits) will be started from 001, next batch requisition serial will be started from 002 and so on.
[][]In every new year, the last three digits (batch requisition serial number) will be started from 001.
[][]Example for presentation of the preprinted ampoule:
WXX001
Where
[][]W stands for Water for injection
[][]XX stands for year of 20XX
[][]001 sands for serial number of batch manufactured in year of 20XX.
Annexure:
Annexure-I: Packaging Material Code