The part 1 of this two-part series explores key foundational concepts, starting with the definition of product release and its critical role in guaranteeing the safety and effectiveness of drugs.

Overdue CAPAs may result in unresolved quality issues, which can affect product safety and effectiveness. Learn about the risks of overdue CAPAs and how to prevent them.

Thank you, Austin Medtech Connect, for hosting an inspiring summit!

In FDA-regulated industries, batch records are the cornerstone of quality and compliance. These records document every step in the manufacturing process, ensuring that products are produced consistently, meet predefined specifications, and comply with regulatory requirements.

MasterControl's GxP Lifeline Blog is a wealth of information and BatchWize is honored to have contributed to the topic of Quality Managements Systems (eQMS), and Electronic Batch Records.

At BatchWize, we have the ability to customize our services to meet our client’s needs. Some clients benefit from a full and thorough manufacturing batch record review, some clients need help reviewing nonconformances, and others want a closer look at their manufacturing data using trending and process visualization tools. 

Making small amounts of herbal products for friends and family can be quite different than making herbal products on a large scale for commercial use. When deciding to make a product for sale, it is always a good idea to keep detailed records, also known as Batch Records or Manufacturing Batch Records. But what exactly is a Batch Record? Why is it important? And why would I need one? Let’s take a closer look.

Manufacturing Batch Records are essential documents that provide a detailed account of the production process for a specific batch of a product. Batch Records are critical for manufacturers and license holders in regulated industries like Pharmaceuticals, MedTech, Food & Beverage, Supplements, and Cosmetics.