An Audit Trail Report is a critical component of compliance with 21 CFR Part 11, which establishes regulations for electronic records and electronic signatures in the pharmaceutical and...

Good Engineering Practice (GEP) in the pharmaceutical industry refers to established engineering methods and standards used to ensure that facilities, systems, and equipment are designed, built, and...

In the pharmaceutical industry, regulatory compliance ensures that drugs are produced in safe, controlled environments that meet strict quality standards. It is not just about meeting legal...

To explain real-life examples of how pharmaceutical companies apply 21 CFR Part 211 in their operations, here are practical scenarios that showcase the use of specific sections of the regulation in...

In this article we are going to learn all aspect of tablet tooling. What is tablet tooling, purpose of it, different types of tooling and many terms related to it. What is Tablet Tooling? Tablet...

Anyone who has worked in the tablet production area or on a tablet compression machine is familiar with punch tightness or stickiness caused by sticky materials. Sticky materials can cause damage to...