sop for batch manufacturing



To lay down a procedure for Batch Manufacturing.

2.0 SCOPE:
This SOP is applicable for Batch Manufacturing in production area

Officer/Executive Production

Head Production
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

Not Applicable

• Controlled Copy      :Production
• Controlled Copy     : Quality Assurance
• Master Copy            :Quality Assurance


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 placebo batch

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

sop for Sanitization of Seals

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 equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

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


















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