by Dr. Yashashwini Reddy | Jun 2, 2024
In this article, we are going to see the overview of the Purple Book and its contents, and how it helps healthcare professionals, The FDA Purple Book contains the list of approved biological products, and here we are going to see the details of the Purple book, its...
by Dr. Yashashwini Reddy | Jun 2, 2024
How orphan drug designation is given in Japan In the previous articles we have studied orphan drugs and now we are going to learn about how orphan drug designation is given in Japan, we are going to discuss how and what are the laws guiding orphan drug designation in...
by Dr. Yashashwini Reddy | May 24, 2024
Standard Operating Procedure for Cleaning of Fluid Bed Dryer Bag 1.0 OBJECTIVE: To lay down the cleaning procedure for the FBD bag 2.0 SCOPE: This SOP shall be applicable for the FBD Bag in the Granulation area in the Production department. 3.0 RESPONSIBILITY: 3.1...
by Dr. Yashashwini Reddy | May 19, 2024
For tablet coating operation, we use different capacities of pan according to the batch size so how do we select a specific pan capacity for the batch to ensure an efficient coating process, let’s see in detail in this article Tablet coating machines will have...
by Dr. Yashashwini Reddy | May 17, 2024
In this article, we are going to learn the concept of process validation in concise . Validation is an act of proving right with documented evidence, suppose you create a new password, and the system to validate your password, asks you to re-enter so that you are...