by Dr. Yashashwini Reddy | Jun 9, 2025
Recovery Factor Determination in Cleaning Validation What is Recovery Factor?Recovery Factor (RF) is a measure of how effectively an analytical method can extract and detect a known quantity of residue from a surface or sampling medium (e.g., swabs, rinse solutions)...
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 | May 13, 2025
Standard Operating Procedure (SOP) Here’s a detailed Standard Operating Procedure (SOP) for the Instrument for Macroscopical Examination, used to visually inspect pharmaceutical products (such as tablets, capsules, and other dosage forms) for...
by Dr. Yashashwini Reddy | May 6, 2025
The Instrument and Equipment List for Pharmaceuticals refers to the various tools, devices, and machinery used in the pharmaceutical industry to conduct research, development, production, and quality control. These instruments ensure the safe, efficient, and compliant...