by Dr. Yashashwini Reddy | Apr 29, 2025
Analysis of Out of Specification (OOS) Occurrences in Pharmaceutical Products In the pharmaceutical industry, the term Out of Specification (OOS) refers to situations where the results of tests or measurements fall outside the predefined limits or specifications set...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To establish a standardized method for qualifying personnel in proper gowning procedures to ensure compliance with cleanliness and contamination control requirements in controlled environments...
by Dr. Yashashwini Reddy | Apr 25, 2025
Standard Operating Procedure (SOP) Here’s a detailed Standard Operating Procedure (SOP) for the Bubble Point Test, which is commonly used to verify the integrity of membrane filters—especially in sterile pharmaceutical or biotech processes....
by Dr. Yashashwini Reddy | Apr 22, 2025
Standard Operating Procedure (SOP) 1. Purpose To define the procedure for sampling of primary, secondary, and tertiary packing materials to ensure that the materials received conform to the required quality standards before use in production. 2....
