Sop batch demarcation and batch coding


Sop batch demarcation and batch coding


To laydown the procedure for batch demarcation and batch coding.

Production officer

Production manager

Batch size for different dosage forms are determined on the basis of following parameters :
1. Uncoated Tablet – mixing capacity and blending
2. Coated Tablet – coating capacity
3. Capsule – blending capacity
4. Liquid Oral – mixing capacity
5. Injection – mixing and sterilization capacity

The quantity once mixed or blended is dealt uniformly under identical conditions throughout the process.

For each product, batch size and batch demarcation is done as per the master formula. If batch size is to be altered from what it is written in master formula record,

it is done by geometric proportions like half, one-third etc.

To have proper traceability, all the input materials of one batch should be drawn from single batches of individual material.

If the active ingredient quantity available form a single batch is not adequate for one batch, the remaining quantity can be drawn from

a different R.M. batch whose assay is within + 1.5% of the previous batch.

In other case the batch size is reduced to match the R.M. available from the single

A master record is kept for batch sizes vis a vis product in the format given in Annexure 1

Batch Coding is done by following the under mentioned norm.


First Two letters                                –           Abbreviation of product


Third letter                                         –           Referencing dosage form


Three Nos.                                        –           Serially in order


e.g. Ampicillin Capsules                 –           APC 001

(batch no. 1)

Batch coding master record also is maintained in the format

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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