DOCUMENT OVERVIEW
What this Batch Numbering System SOP covers
Prepared by PharmaEdges
A batch numbering system connects a manufactured batch to its records through a defined identifier. This template describes product codes, year identifiers and serial numbers for finished products, intermediates and working standards.
The procedure also distinguishes lots, reprocessed or reworked batches, purification batches and development batches. It explains maintenance of the product coding lists and controlled distribution to QC. The numbering conventions are a template to adapt, not a universal format prescribed for every manufacturer.
How the batch numbering system works
These examples explain the scope of the template. Apply the reviewed and approved site procedure in actual work.
1. Select the approved product code+
Identify the finished product or intermediate using its approved coding list. Confirm the applicable category, such as a routine batch, lot, development batch or working standard, before constructing the identifier.
2. Combine the year, product code and serial number+
The template combines a year identifier, a product code and a sequential number. Illustrative example: 26AM0001 represents year 2026, product code AM and serial 0001 under the example convention. This is an explanation of the template, not a batch number to assign without checking the site register.
3. Check special categories and consistency+
The procedure includes category markers for lots, reprocess/rework, purification and development batches. Confirm the approved code, serial-number length and consistency with the relevant examples; working-standard numbering needs separate attention.
4. Maintain and distribute the coding lists+
Update the controlled finished-product or intermediate coding list when a new code is introduced. Maintain the approved list with the master procedure and distribute the revised controlled copy to QC as defined by the site.
What is included in this SOP package
Product Coding - Finished Product (FP)+
Maps each finished product to its routine, lot, reprocess/rework, purification, working-standard and development codes. Adapt the code definitions and approval fields before use.
Product Coding - Intermediate (IN)+
Maps intermediate products to their approved intermediate and development codes so personnel use the same identifiers across related records.