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...
by Dr. Yashashwini Reddy | May 19, 2025
Validation Protocol Writing a validation protocol is a critical step in ensuring that pharmaceutical processes, equipment, or systems consistently produce products meeting predefined quality standards. Here’s a comprehensive guide...
by Dr. Yashashwini Reddy | May 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
by Dr. Yashashwini Reddy | Nov 5, 2024
Temperature Mapping in Pharmaceutical Storage Areas: Procedures and Best Practices Temperature mapping is a foundational process in pharmaceutical storage to ensure products are kept within prescribed temperature ranges. Proper mapping procedures, supported by...
by Dr. Yashashwini Reddy | Oct 18, 2024
Importance of Recalls in the Pharmaceutical Industry: Safeguarding Public Health and Compliance In the pharmaceutical industry, ensuring the safety, efficacy, and quality of drugs is of paramount importance. Despite stringent quality control measures and regulatory...
