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...
This Document describes (Standard Operating procedure) SOP for Batch Release and Rejection. SOP for Batch Release and Rejection. I. Purpose & Scope: The purpose of this SOP for Batch Release and Rejection. This Standard...
This article contains tools or brief idea about for finding out Root cause i.e. Methods of Root Cause Investigation Methods of Root Cause Investigation 1 Introduction : Within the regulatory framework of pharmaceutical manufacturing...
