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...
This article contains the information about Bioburden study protocol for finger/Bonnet/Filter bag Bioburden study protocol for finger/Bonnet/Filter bag RECOVERY OF MICROBIAL BIOBURDEN FROM THE RINSE SAMPLE OF FINGER/BONNET/FILTER BAG AND FILTER TO INCREASE THE...
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 article contains...
