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 contains information about Desiccator – A Quality control Laboratory Device which is used in the Quality control laboratory used to maintain the dryness of samples by removing moisture from an enclosed space. Desiccator –...
This article contains why Prednisone Tablet USP Standard used in Dissolution Tester Calibration, Why Prednisone Tablet USP Standard used in Dissolution Tester Calibration Dissolution Tester Calibration in brief : Dissolution testing is a critical...
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 the description about Petri dishes/Plates position while keeping in incubators for incubations: A) Why are Petri Dishes/plates placing in Inverted position in Incubators? When incubating bacterial plates, they are inverted lid...
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 Stability Study requirements Across Major Regulatory Agencies Stability Study Requirements Across Major Regulatory Agencies 1. USFDA for USA Guideline Reference : ICH Q1A(R2) Conditions: Long-term: 25°C ± 2°C / 60%...
Why Orthophosphoric acid (H₃PO₄) is commonly used for pH adjustment in High-Performance Liquid Chromatography (HPLC) analysis, in the pharmaceutical industry. Orthophosphoric acid (H₃PO₄) usages in Chromatography Orthophosphoric acid (H₃PO₄) is commonly used for pH...
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...