According to the USFDA, a batch is a particular amount of a drug or other material that is created in accordance with a single manufacturing order during the same manufacturing cycle and is expected to have uniform character and quality, within certain bounds. Therefore, a batch is a predetermined quantity of an API or other material that is treated in one or more ways to show the product's homogeneity.
What is a Batch Number?
The batch number is a designation printed on the drug product's label so that you can keep track of each batch produced. In addition to identifying the batch produced, the number will include particulars relevant to control and manufacture.
An identification that is printed on the label of a drug that allows the history of its creation to be tracked is called a batch number. This entails not only identifying the precise batch that was manufactured but also ensuring that all pertinent control and manufacturing details can be traced back to the batch number.
Therefore, it is crucial that all batches of tablets receive an identification number as soon as they leave the tablet compression machine or capsule filler or powder filling, or liquid filling, and before moving on to the packing stage.
What is Batch Tracking?
This is a simple way of tracking your batches of manufactured to optimize the management of your supply chain and keep on top of quality control. Using batch tracking, you can quickly identify and locate stored goods when they’re being shipped, stored in warehouses, or distributed to consumers.
ALSO READ: SOP for Batch Numbering System
How Does Batch Number Tracking Work?
If you’re implementing a batch number tracking system, here are some of the steps you can follow to ensure all controls are in place.
Define the batch size:
When itemizing the batch, you need to ensure the products were manufactured using the same raw materials, by the same machine and team, during the same period of time.
Choose your batch format:
Your batch numbers should be unique combinations of letters and numbers. It’s best to include the product’s date and initials for easy searching.
Keep track:
You’ll need to log all the details of the batch in a Batch Manufacturing record.
Label batches:
Choose how you’ll label the batches, whether it’s print or sticker, and what type.
Include all batch details:
Every batch needs information pertaining to the batch. This could include,
- Dates of the manufacturing process
- Bill of materials
- Details of the person verifying the process
- Health and safety information
- Maintenance and cleaning information
- Quality control test results
- Equipment and processing lines
- Supply line details
- Quantity of goods produced
- Best before date
- Weight of active ingredients
ALSO READ: Why Three Batches are Taken for Validation?
Why Use Batch Number Tracking?
You might have a general idea of why batch number tracking is useful, but here’s an in-depth look at why you should be implementing it as a manufacturer.
Quality Control
Using batch numbers, you’re able to quickly identify any defective raw materials which are vital for product recalls. If there is any product defect, whether the materials, parts, or machinery, you can easily determine the source of the problem and rectify the situation.
Customer Relations
When products need to be replaced or repaired, the batch number will allow you to identify the relevant information, keeping your customers satisfied.
Regulatory Compliance
Many countries legally require a batch tracking system which will have to be considered when deciding what to include.
Streamlined Expiring Tracking
Batch number controls are an important way to ensure high-quality production at all times. With batch number controls, the expiration date of food will need to be tracked to keep consumers safe.
Prevent Counterfeits
Using batch control numbers prevents the emergence of counterfeited items from entering your inventory. This is particularly important if your products are susceptible to fakes, as you can pick up counterfeits quickly to protect your profit margin.
Reveal Trends
Batch control numbers are also able to provide you with useful insights into your business such as which batches are selling better than others. This way you can quickly notice trends in which items are best to stock.
Importance of the Batch Number for Pharmaceutical Companies
Batch number is also referred to as “lot number”. Typically, batch and batch number recording begin at the manufacturing facility. Batches should be kept track of and recorded using:
- Quantity
- Manufacturing cycle
- Expiry date
- Weight of the active ingredient
- Excipient(s)
Each pharmaceutical batch is given a special identification number that is written on the batch documentation in accordance with regulatory requirements. At the end of the manufacturing process, such as during packaging, the specified batch should be clearly printed on the labels in order to identify all the steps in the production process.
A sample of every batch of product is then stored for the remaining shelf life + one year. Following the completion of the production of a single lot or batch of medicine, all equipment must be sanitized and cleaned in accordance with regulatory requirements. When beginning the formulation or production of a new medicine, sanitation is done to avoid any potential contamination. To determine whether the equipment complies with the necessary requirements of cleanliness, the QA department should do inspections.
On behalf of which, one can review the whole manufacturing history up to that point using the precise lot or batch number. The manufacturing and expiry dates can be checked. You can check the prices for the chosen batch.
What are the Benefits of Automating Batch Number Controls?
If you’re in the manufacturing industry and are looking at implementing batch number controls, you will probably be considering an automated system. Here’s why an inventory management system such as this can be so beneficial to your business. This can be a really affordable and user-friendly process when you’re working with the right company.
With batch number tracking automation, you can improve integration, compliance, and customer relations. This simplifies your quality control as you’re easily able to track your products across the company.
Automation gives access to everyone in your organization, as they can easily access, trace and verify batch numbers and warranty information. Through automation, you’re able to quickly troubleshoot which means tracking and removing any expired products from the shelves.
With batch number automation there’s improved accuracy which means improved regulatory compliance and less chance of charges. Improved compliance means more likelihood of increased sales over time. With automated batch number controls, there are fewer accounting errors than with manual tracking.
The Ministry of Health's Focus on the Batch Number
According to the country's Ministry of Health, the lot number or batch number must be printed on the bottles, packs, and cartons. The number is significant because it might be needed, particularly if a vaccine or capsule is recalled or there is a problem with the batch's quality.
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