SOP on Analytical Requisition Numbering Procedure for In-process, Finished Product and Wash Water Sample
Objective : To lay down a procedure for analytical requisition numbering system for in-process, finished product and wash water sample.
Scope : This standard operating procedure is applicable for assigning analytical requisition number to in-process, finished product and wash water sample at formulation plant.
Responsibility
Officer/Executive-Production shall be responsible for giving the analytical requisition number to in-process, finished product and wash water sample as per this SOP.
Officer- IPQA shall be responsible for implementation of the procedure as per this SOP.
Head-Quality Assurance/Designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
In-process Materials :The samples which are drawn during manufacturing process for analysis as per BMR
Finished Product Sample : The samples which are drawn after completion of packing process for complete analysis as per BMR.
Procedure : FOR IN-PROCESS SAMPLE AND FINISHED PRODUCT SAMPLE
The analytical requisition number shall be numbered by eleven characters.
The first character of analytical requisition number shall be first alphabet of the type of the Block i.e. ‘M’ stands for Main Production Block, ‘L’ stands for Liquid Block and ‘S’ stands for Soft Gelatin Block and so on. If the first alphabet of the two blocks is same then second alphabet shall be considered for the next coming block.
The second character of analytical requisition number shall be the first alphabet of the type of dosage form i.e. ‘T’ stands for Tablet; ‘C’ stands for Capsule, ‘L’ stands for Liquid, ‘O’ stands for Ointment and so on.
The third character of analytical requisition number shall be first alphabet of the type of the sample i.e. ‘I’ stands for in-process sample and ‘F’ stands for finished product sample.
The fourth character shall be ‘-‘(dash).
The fifth, sixth, seventh and eight characters are numbers, which shall denote serial number of the requisition. The first analytical requisition number shall be 0001. The subsequent serial numbers shall be 0002, 0003, and so on.
The ninth character shall be ‘-’ (dash).
The tenth and eleventh characters shall represent the financial year e.g. 25 for April 2025 to March 2026.
First in-process sample of Tablets from main production block in financial year from April 2025 to March 2026 shall have analytical requisition number as MTI-0001-25.
FOR WASH WATER SAMPLE
The analytical requisition number shall be numbered by ten characters
The first character of analytical requisition number shall represent the section or block e.g. ‘M’ stands for Tablet and capsule section in Main Production Block, ‘L’ stands for Liquid block, ‘O’ stands for Ointment section in Main Production Block and ‘S’ stands for Soft Gelatin Block, ‘W’ stands for Stores / Warehouse and so on.
The second character of analytical requisition number shall ‘W’ stands for Wash Water
The third character shall be ‘-’ (dash).
The forth, fifth, sixth and seventh characters are numbers, which shall denote serial number of the requisition. The first requisition number shall be 0001. The subsequent serial numbers shall be 0002, 0003, and so on.
The eight character shall be ‘-’ (dash).
The ninth and tenth characters shall represent the financial year e.g. 25 for April 2025 to March 2026 etc.
First wash water sample of main production block in financial year from April 2025 to March 2026 shall have analytical requisition number as MW-0001-25.
For Cleaning Validation Wash Water Samples
While assigning the requisition number to the Wash Water samples for cleaning Validation all the characters shall remain the same as that of other samples of the Wash Water for the respective area except for the second character in place of ‘W’ Alphabet ‘C’ representing ‘Cleaning Validation’ shall be assigned .e.g. MC-0001-25 is assigned for “1st Wash Water sample for cleaning validation of the year 2025-26 of the Main block”.