This article describes about Purified Water System Qualification in the Pharmaceutical Industry. Purified Water System Qualification in the Pharmaceutical Industry: A Complete Guide Introduction Water is one of the most critical raw materials used...
Equipment Qualification in Pharma: Ensuring Compliance, Accuracy, and Product Quality Introduction In the pharmaceutical industry, equipment qualification in pharma is a vital component of Good Manufacturing Practice (GMP) compliance. It ensures that every piece of...
This article describes about what must be done when Transfer of Material/Equipment in Aseptic area. Transfer of Material/Equipment in Aseptic area What can be done when materials and/or equipment are being transferred into a...
This articles contains information about Cpk (Process Capability Index) and Why CpK greater than 1.33 is considered acceptable Why CpK greater than 1.33 is considered acceptable The Cpk (Process Capability Index) is a statistical measure...
This article describe about to provide a scientific justification for the selection of worst-case container configurations for requalification of a depyrogenation tunnel. Scientific justification for the selection of worst-case container configurations for requalification of...
This article contains Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies: Biowaiver Criteria for Multiple Strengths Biowaiver Criteria for Multiple Strengths Across Regulatory Bodies (When Bioequivalence study is Done on One Strength) When...
This article contains the information about the Neutral Code. Neutral Code A brief information About the Neutral Code : A “neutral code” is a unique alphanumeric identifier issued by a regulatory body , like...
This document provides the information on data integrity policy i.e. policy to investigate and handle incidences related to GXP data, identified during internal/external audit or during review of data at any stage. Data integrity...
This article contains the Measures/Controls available to avoid Cross Contamination in Manufacturing and Packing Operations Measures/Controls available to avoid Cross Contamination in Manufacturing and Packing Operations Operations Unit Operations Measures / Controls Dispensing Dispensing –...
This Article contains the Master investigation Report Template which will be useful for the Preparation of Investigation and Harmonize the Investigation Format across the Site which will avoid the variability of contents in each...