In process checks are an important part of quality control for pharmaceutical manufacturing. These checks are performed at various stages of the manufacturing process to ensure that the finished product meets the required standards.
There are a number of different types of in process checks, each with its own specific purpose. These checks are typically performed at specific production stations and/or on a sporadic basis throughout the manufacturing process.
For example, the importance of in-process checks during the compression process of pharmaceutical tablets has been well established. It has been shown that in-process checks that measures the physical attributes of the tablet, such as hardness, thickness, friability, and disintegration time can help to prevent tablets from becoming cracked or chipped.
In process checks help to identify any issues with the manufacturing process. For example, if the compression test results are outside of the acceptable range, it could be an indication that the finished product will not meet the necessary quality standards. In this case, further investigation would be needed to determine the cause of the problem and how to fix it.
In conclusion, In-process checks (IPC) are a necessary part of the manufacturing process for pharmaceuticals. These checks help to ensure that the products being produced meet the quality standards set by the FDA. In-process checks can be time-consuming and add some cost to the manufacturing process, nevertheless, they are vital part of production to ensure that the finished product meets all the required specification and is safe for human use.
Capability of BatchLine
Despite the importance of in-process checks, many pharmaceutical companies do not have adequate systems in place to perform these checks and still largely rely on paper batch system to fulfill these quality control requirements. This often leads to products that do not meet quality control requirements, which can put patients at risk.
BatchLine application offers a unique opportunity for pharmaceutical manufacturer to record IPC values electronically. The application supports in process checks equipment and scale integration via IoT gateway, thereby, enabling automatic IPC entries into the batch record and reduces human errors that are often tie to the process. Moreover, BatchLine application also generate a report and graphs that include statistical values and data associate with IPC.
BatchLine, assist your production and quality team with a smarter, faster and compliant way of working with a batch record.
Smarter, Faster, and Higher Quality Manufacturing with BatchLine
Laksanaree Prongfah, Senior system support engineer
The benefits of automating IPC with BatchLine