sop for batch manufacturing
1.0 OBJECTIVE:
To lay down a procedure for Batch Manufacturing.
2.0 SCOPE:
This SOP is applicable for Batch Manufacturing in production area
3.0 RESPONSIBILITY:
Officer/Executive Production
4.0 ACCOUNTABILITY:
Head Production
5.0 PROCEDURE:
5.1 PRECAUTIONS:
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.
60 ABBREVIATION:
WFI : Water for Injection
LAF :Laminar Air Flow
Mfg. : Manufacturing
QA :Quality Assurance
BMR : Batch manufacturing record
QC :Quality Control
Pvt. :Private limited
7.0 ANNEXURES:
Not Applicable
8.0 DISTRIBUTION:
• Controlled Copy :Production
• Controlled Copy : Quality Assurance
• Master Copy :Quality Assurance
9.0 REFERENCES:
In House
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area