Massimo Crudeli
What batch number compliance means in the pharmaceutical industry
All companies operating in the life sciences industry must comply with current regulations (e.g. US FDA) and guidelines (e.g. cGMP). Regulations require materials to be uniquely identified and their production history to be traceable at any point in time.
A batch (also called “lot”) is a quantity of materials sharing the same properties within specified limits and produced according to a single manufacturing order during the same cycle of manufacture. In essence, a batch can be defined as materials with certain specific characteristics (e.g. expiration date and physical/chemical properties).
Batches of material are traced through batch numbers, and therefore, correctly assigning batch numbers is essential for traceability. Precise rules for batch number assignment are vital in the life sciences industry to ensure compliance. For instance, the ability to trace back the history of a given batch of manufactured products and all the ingredients used for its production guarantees the highest degree of patient safety.
The danger of duplicate batch numbers
It is of paramount importance to eliminate the possibility of accidentally having duplicate batch numbers. The presence of duplicate batch numbers could bring confusion and have dangerous consequences with the result that the batch could be compromised. Imagine, for example, what could happen if a wrong batch of material is picked from the warehouse and consumed in production or shipped to the final customer.
For compliance and full traceability purposes, the combination of the item code and batch number should be unique.
How STAEDEAN enforces batch number uniqueness
STAEDEAN offers different ways to implement batch number uniqueness: it is possible to control the item/lot combination or, even the lot uniqueness across multiple items (advanced batch number uniqueness). By enabling this feature, STAEDEAN will not allow multiple items to have the same batch number.
STAEDEAN goes one step further
Additionally, STAEDEAN allows to identify and track sub-batches (also called “containers” or “single product units”). Each sub-batch has a parent-child relationship with the corresponding batch, and their numbers are, again, unique throughout the system.
By reading a sub-batch number, operators can easily retrieve precise information about the container and lot (e.g. status and storage conditions/attributes). The combination of batch and sub-batch numbers and their uniqueness ensure the full traceability of material at any point in time and compliance with industry regulations and guidelines.
Want to learn how STAEDEAN ensures batch number uniqueness and how your life sciences organization can benefit by it?
Massimo Crudeli