sop for batch manufacturing
To lay down a procedure for Batch Manufacturing.
This SOP is applicable for Batch Manufacturing in production area
5.1.1 Always follow manufacturing instructions according to the respective BMR.
5.1.2 Prepare One Batch at one time.
5.1.3 Calculate the final volume as per the specific gravity of the solution.
5.1.4 In case of preparation of suspensions ensure the proper working of LAF and start
LAF 30 minutes before preparation of the batch.
5.2 Ensure that area is clean and free from previous product material, containers and documents.
5.3 Recheck the tags of all the ingredients to be used for batch manufacturing and ensure that
they match as per entries made in the Raw Material dispensing details in BMR.
5.4 Ensure that the tank is clean & sterilized.
5.5 Check the status board affixed on the mixing tank “Ready for Use”, also verify the cleaning
and sterilization records, Ensure that the bottom outlet valve of the mixing tank is closed.
5.6 Collect water for Injection in the mixing tank as per quantity mentioned in the BMR, start the stirrer
and add ingredients one by one through the main hole of the tank as per Standard Procedure
for manufacturing of particular product mentioned in the BMR.
5.7 Send the WFI sample to Quality Control for testing.
5.8 On approval of WFI sample from QC department, affix a status board on the Mixing tank
under manufacturing with Product Name, Batch No., Batch Size and Date.
5.9 Continue stirrer according to the time specified in respective BMR
5.10 Stop the stirrer.
5.11 Make up the volume to the required batch volume with Water for Injection & check in load cell.
5.12 Start the stirring after volume make up for time specified in BMR.
5.13 Intimate to QA collect bulk sample and send QC for analysis along with the bulk intimation slip.
5.14 After getting clearance of bulk analysis from Quality Control and instruction from Manufacturing
Chemist, start the pre-filtration of the bulk solution.
WFI : Water for Injection
LAF :Laminar Air Flow
Mfg. : Manufacturing
QA :Quality Assurance
BMR : Batch manufacturing record
QC :Quality Control
Pvt. :Private limited
• Controlled Copy :Production
• Controlled Copy : Quality Assurance
• Master Copy :Quality Assurance
Online Rejection in parenteral