Sop batch demarcation and batch coding
1. PURPOSE & SCOPE
To laydown the procedure for batch demarcation and batch coding.
2. RESPONSIBILITY
Production officer
3. AUTHORITY
Production manager
4. PROCEDURE
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
Batch.
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 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