Sop batch demarcation and batch coding
1. PURPOSE & SCOPE
To laydown the procedure for batch demarcation and batch coding.
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