Common Tablet Manufacturing Defects in Pharma | Part-3
Black Spots Black-colored specks or dots on the tablet surface. Causes of Black Spots: Impurities a…
Black Spots Black-colored specks or dots on the tablet surface. Causes of Black Spots: Impurities a…
Mottling Uneven distribution of color or pigmentation on the tablet surface. Causes of Mottling: C…
1. Capping Partial or complete separation of a tablet's crown or upper portion from the main bo…
Similarities 1. Both aseptic and terminal sterile manufacturing processes aim to prevent contaminat…
Process capability measures the inherent variability of a stable process that is in a state of stat…
Introduction In September 2022, the U.S. Food and Drug Administration (FDA) released a draft guidan…
The knowledge gained through appropriately designed development studies culminates in the establish…
pH is a measure of a solution's acidity or alkalinity. In the pharmaceutical industry, pH is im…
A pharmaceutical manufacturing process usually consists of a series of unit operations to produce t…
Over the years, QbD’s focus has been on the process design, understanding, and control, as discusse…
Technology Transfer Protocol An authorized technology transfer document, such as a Master Plan (or …