Neutral Code
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...
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Data Integrity Policy
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...
Bioburden study protocol for finger/Bonnet/Filter bag
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...
Controls available to avoid Cross Contamination in Manufacturing Area
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 –...
investigation Report Template
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...
EHS instructions During Manufacturing
This article contains...
Regulatory Terminology for Ambient, Room Temperature and Cold Chain
This article contains information about clarification and regulatory terminology about “Ambient”, “Room Temperature” and “Cold Chain”. Regulatory Terminology for Ambient, Room Temperature and Cold Chain : On the outer packaging of pharmaceutical products one...
Sections in Pharmaceutical Formulation Facility
This article describes about Different Sections/Areas available In the Pharmaceutical Formulations Facility : Different Sections/Areas in Pharmaceutical Formulations Facility. Oral Solid Dosages and Sterile Preparations : Warehouse : Raw Material Store – Quarantine area/Under...
D value- Importance in sterilization process
This articles contains the importance of D Value in sterilization process in the context of Biological Indicators D value- Importance in sterilization process : The “D value” in the context of biological indicators (BIs)...
Peak Splitting in Chromatography
This Article contains the information about Peak Splitting which is commonly observed in the Chromatographic analysis.. Peak Splitting in Chromatography : Peak splitting in chromatography refers to the appearance of shoulders or twin peaks...