What is a Batch Record?

Since every patient deserves drugs that are safe and efficacious, quality is key for any manufacturer of (bio)pharmaceuticals.

But how do you know that a drug was produced in a way that its quality is up to standards? Strict regulation was put in place, known as Good Manufacturing Practices (GMP), which requires that the production process is thoroughly documented. This is where the batch record comes into play.

It is this batch production software that allows manufacturers to answer questions that are critical to product quality, such as; Who did what, and when? Which materials were used? Which procedures were followed and were the results within specifications?


Batch record definition

The batch record provides the complete manufacturing history of a product and is, therefore, the crown witness of the quality of a pharmaceutical product. The document provides proof that Good Manufacturing Practices (GMP) were followed and that the production process followed the specifications as described in the official recipe, i.e. the master batch record, of the product.

What information can be found in the batch record?

The exact content and format of the batch record depend from company to company and product to product. The following elements can generally be found in every batch record:

General batch information

Each batch needs to be given a unique batch number or lot number. This number serves as the unique identifier of the produced lot of medicine. Each record related to the batch should be clearly identifiable via this unique ID.

Furthermore, a precise description of the batch is required. For example, the start date and end date of the manufacturing run, the storage conditions, the batch composition, manufacturer license number, expiry date, labeling information, etc. need to be mentioned