by Dr. Yashashwini Reddy | Jun 9, 2025
Three Consecutive Batches for Validation in Pharmaceuticals Definition: In pharmaceutical manufacturing, validation is the documented evidence that a process consistently produces a product meeting its predetermined quality specifications. One of the critical...
by Dr. Yashashwini Reddy | Jun 9, 2025
Validation of Compressed Air frame 1. Introduction Importance of compressed air in pharmaceutical manufacturing. Regulatory expectations (e.g., EU GMP Annex 1, ISO 8573, WHO guidelines). Role of compressed air in cleanroom environments, product...
by Dr. Yashashwini Reddy | Jun 9, 2025
🔹 What is Contamination in Pharma Manufacturing? Contamination refers to the unintended presence of chemical, microbial, particulate, or cross-substance materials in a product or manufacturing environment. It can affect product safety, efficacy, and regulatory...
by Dr. Yashashwini Reddy | May 19, 2025
A Site Acceptance Test (SAT) is a critical phase in the commissioning process of equipment or systems. Conducted at the customer’s site after installation, the SAT verifies that the system operates according to specified requirements in its actual operating...
by Dr. Yashashwini Reddy | May 19, 2025
The U.S. Food and Drug Administration (FDA) has issued multiple warning letters to pharmaceutical and medical device manufacturers for deficiencies in cleaning validation processes. These letters highlight the critical importance of robust cleaning procedures to...
