Batch number simple explained

B12345678-AB

This example batch number consists of:

• A prefix "B" that could identify the type of batch or product
• A consecutive eight-digit number "12345678" that identifies the specific batch
• A suffix "-AB", which could contain additional information such as the production location or production line

The use of batch numbers is a basis for ensuring quality and safety in almost every industry. In most industries, such as pharmaceuticals, food and cosmetics, batch numbers are mandatory.

Batch numbers provide information about this:

• who
• when
• where
• with which machines and raw materials

has manufactured a product.

The batch number is usually found on the packaging of the product and should never be confused with the barcode or EAN number.

Thanks to batch numbers, it is possible to precisely assign products to a production process even after they have been delivered. The aim is complete batch traceability. This is helpful when defects occur. In this case, it is possible that the discovered production error affects not only an individual product, but the products of the entire batch. Defective batches can therefore be traced and removed from the market as quickly as possible. Click here for the details:

Traceability and transparency

Batch numbers enable companies to trace the production path of a specific product from the receipt of raw materials to the end customer. This is particularly important in regulated industries such as pharmaceuticals, food and cosmetics to ensure that each product meets quality standards and complies with all relevant regulations.

Quality control

By using batch numbers, companies can systematically carry out and document quality controls. Should a quality problem be identified, the affected batch can be quickly isolated and analyzed to identify and correct the cause of the problem.

Product recalls

In the event of product defects or safety issues, batch numbers enable efficient and targeted recalls. Instead of recalling all products, only the affected batches can be recalled, saving costs and minimizing damage to the company.

Inventory management

Batch numbers help to monitor and manage stock levels. They enable accurate inventory management and help to avoid overstocking or shortages. They also facilitate the FIFO (First In, First Out) or LIFO (Last In, First Out) process to ensure that older stock is used first.

Legal and standards compliance

Many industries are required by law to ensure the traceability of their products. Batch numbers play a crucial role in complying with these legal requirements and standards, such as Good Manufacturing Practices (GMP) in the pharmaceutical industry or FDA regulations.

Analysis and reporting

Batch numbers enable detailed analysis and reporting across the entire production and supply chain. Companies can identify trends and patterns, optimize production processes and make informed decisions based on the data collected.

Customer satisfaction

The ability to identify and track specific batches enables companies to respond to customer inquiries or complaints in a targeted manner. This improves customer satisfaction and strengthens trust in the brand. Overall, batch numbers contribute significantly to ensuring efficiency, safety and quality in production and the supply chain, as well as meeting legal requirements.

Batch numbers play a crucial role in the chemical, cosmetics, food, biotechnology, pharmaceutical and medical device industries. Their importance extends to various aspects such as traceability, quality assurance, legal regulations and customer satisfaction.

Food batch number

In addition to data such as the sales name, list of ingredients and additives, best-before date, etc., the batch number is also mandatory for food labeling. If it turns out that a food could pose a risk to consumers (e.g. due to contamination), the faulty batches can be recalled via a product recall.

Pharmaceutical batch number

In Germany, the German Medicinal Products Act (derived from the EU GxP guidelines) regulates the mandatory labeling of medicines. In addition to data such as the drug name, strength of the drug, dosage form, etc., the manufacturer's approval number and, for batch-produced drugs, the batch designation ("CH-B") must also be listed.

Medical device batch number

With the entry into force of the Medical Device Regulation (MDR), a Unique Device Identification (UDI) became mandatory throughout the EU. This means that the obligation to identify and register medical devices has been implemented. The aim is to be able to track medical devices effectively and precisely.

The creation of batch numbers is an essential part of production and supply chain processes as it enables product traceability and quality assurance.

Here are the basic steps and considerations for creating batch numbers:

Defining the format

First, a format for the batch number must be defined. This can be a combination of numbers and letters and should contain unique information about the batch. Common components are:

• Production date or year
• Location or production line
• Serial number or sequence number

Uniqueness

Each batch number must be unique to avoid confusion. A well-designed numbering system ensures that no duplicate numbers are assigned.

Automation

Many companies use ERP (Enterprise Resource Planning) systems to automate the assignment of batch numbers. This reduces errors and ensures that numbers are consistent and compliant.

Manual allocation

In some cases, especially for small companies or special products, it may be necessary to assign batch numbers manually. It is important to have a clear and consistent method to avoid errors.

Labeling and documentation

The assigned batch number must be clearly marked on the product or its packaging. It should also be noted in all relevant documentation, such as production records and delivery documents.

Integration into the supply chain

The batch number must be included with every movement of the goods within the supply chain. This facilitates traceability in the event of recalls or quality controls.

Continuous review and improvement

The procedures for assigning batch numbers should be regularly reviewed and, if necessary, improved in order to meet changing requirements and technological developments.

ERP systems offer the easiest way to trace batches. This allows the individual parameters of products to be taken into account in detail and thus read out. If necessary, products can be tracked simply by determining the batch number and the necessary measures can be taken.

The Yaveon 365 industry-specific ERP solution helps batch production companies to manage and track batch numbers efficiently and effectively, which helps to comply with legal regulations, improve product quality and optimize production processes.

• Yaveon 365 enables comprehensive tracking of batches throughout the entire production process, from the procurement of raw materials to the end customer.
• The software allows specific quality controls to be defined and carried out for each batch, the results to be documented and immediate action to be taken in the event of deviations.
• Supports compliance with GMP and other regulations through detailed documentation and tracking of all batches. This also facilitates quality audits and inspections by authorities.
• Ensures that all changes to batch data are documented and approved to ensure data integrity and security.
• Defines and manages batch characteristics such as production date, expiry date and specific quality characteristics to ensure product consistency and quality.