SOP for Recording observations in Batch manufacturing records
Objective : To lay down a procedure for recording observations in a Batch Manufacturing Record.
Scope : This Standard Operating Procedure is applicable for all the products being manufactured by Formulation Plant.
Responsibility :
Officer / Executive – Production shall be responsible for recording the observations and calculation’s in the BMR as per this SOP.
Officer/Executive –Stores shall be responsible for recording information in weighment sheet as per this SOP.
Officer/Executive –IPQA shall be responsible for review and verification of BMR as per this SOP.
Head-Production, Head Stores and Head-QC shall be responsible for implementation of this SOP.
Head -QA shall be responsible for compliance of this SOP
Abbreviations and Definitions
BMR : Batch Manufacturing Record; filled / unfilled controlled copy of Technical Directions along with other requisite forms / records, which reveals all the information of a batch of a product.
COA : Certificate of Analysis
Procedure :
IPQA, Production, Stores, QC personnel’s shall be responsible for entering data in the BMR.
Officer /Executive – QA shall issue the BMR as per SOP titled ‘Issue, Receipt, Storage and Destruction of Batch Manufacturing Records’.
Each page shall be numbered Starting from index page, page numbering shall be done as 01,02,03,04 …..10, 11 and so on.
Officer/Executive-Production shall assign the Mfg. date and Exp. date of the product as per SOP (Assigning Manufacturing and Expiry dates to the Finished Products) and fill the same in the BMR.
Wherever required Product name shall be written as mentioned in Technical Direction.
Batch number, Batch size, Market, Mfg. date and Exp. Date of the product shall be written clearly, on the respective places and should be easy to read.
No column shall be left blank in the BMR. If a column is not filled same shall be struck off diagonally. No additional abbreviation shall be used except those specified in the formats. If no abbreviation is mentioned in the format NA “Not Applicable” shall be used in column.
Complete signatures of the designated-personnel’s are mandatory at critical junctures i.e. Certificate of release, Index, checklist, COA’s, Request forms, weighment sheets, line clearance records, tags/labels etc.
Initials shall be used by the personnel’s where more than two signatures are required in one box.
No extra marking like tick mark shall be used on any format of the BMR.
Batch size shall be written as per international numbering system, e.g. a batch size of one hundred thousand tablets shall be written as “100,000 tablets”. No abbreviation like lakhs or crore shall be in use.
All labels shall be placed in the BMR in such a way that each label shall be displayed.
If the digits entered in the BMR are below 1 then the number shall start with digit 0 following by the fraction e.g.. we shall write “0.234” instead of “.234”.
Standard abbreviations used in the BMR shall be as follows :-
- ‘kg’ shall stands for kilogram
- ‘mg’ for milligrams
- ‘g’ for grams
- ‘l’ for liter
- ‘ml’ for milliliter
- ‘s’ is used for seconds
- ‘hrs.’ shall be used against hours
- ‘min.’ stands for minutes
If more than one option is given, one shall be selected by ticking the correct option while the other options shall be struck off.
All the calculations shall be recorded in the weighment sheet and back side of the sheet shall be used for longer calculations.
Before proceeding for next stage, Line clearance record shall be verified in the BMR by designated IPQA personnel’s.
BMR shall be filled as per the stage of the manufacturing process.
Date’s and time written in the BMR shall be as per the SOP i.e. 23-07-25 shall be written instead of 23rd, July 2025, or 23-07-2026, or July 23, 2026 and 13:20 hrs. shall be written in the place of 01:20 PM.
Any correction in BMR shall be done as per SOP title Correction of Documentation errors.
The example of method of recording observation in sample label / BMR is displayed.
Note: All personnel’s shall use black ball pen for recording the observations except IPQA personnel’s, they shall use green ink pen for recording their observations in the BMR.