by Dr. Yashashwini Reddy | Apr 28, 2025
Investigation of OOS (Out of Specification) Results in Analytical Testing In the context of pharmaceutical and biotechnology industries, Out of Specification (OOS) results refer to test results that fall outside the predefined acceptance criteria for a given product...
by Dr. Yashashwini Reddy | Sep 29, 2024
“Essential Regulatory Affairs Interview Questions for Freshers in Pharma: Tips & Answers” 1. What is an Abbreviated New Drug Application (ANDA)? Answer: An Abbreviated New Drug Application (ANDA) is a regulatory submission to gain approval for a...
by Dr. Yashashwini Reddy | Sep 4, 2024
Standard Operating Procedure for Cleaning Dust Collectors in Compression Machine 1.0 Purpose This SOP outlines the standard procedure for cleaning the dust collector associated with the compression machine in xyz company 2.0 Scope This procedure applies to the...
by Dr. Yashashwini Reddy | Sep 1, 2024
“Standard Operating Procedure for Vibro Sifter Operation and Cleaning in Pharmaceutical Production” 1.0 Aim 1.1 To establish a standard procedure for the operation and cleaning of the Vibro-Sifter. 2.0 Scope 2.1 This procedure is applicable to the...
by Dr. Yashashwini Reddy | Jul 2, 2024
What is an Audit trail? In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic...
