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Overview
Key module objectives
• ​Identify the types of IPC, characteristics and implementation in cGMPs​
• Recognize different approaches & methods to realize physiochemical, microbiological and biochemical IPCs in cGMPs
• Carry-out different IPCs (physiochemical,
microbiological, biochemical) in cGMPs and understand impact of potential gaps on process or product quality
Target audience
Technicians, operators, supervisors, managers, quality technicians who work in the USP environment
Module Overview
Activity 1: The Fundamentals of In Process Controls (IPCs) for USP in cGMPs
1/ Overview of IPCs
• What are In-Process Controls (IPC)?
• Why are IPC important, specifically working with biologics?
• The three main IPC categories (biochemical, microbiological, physicochemical)
• Differences between off line,
in line and at line IPCs
2/ Basics of sampling
• What is sampling?
• The sampling plan
Activity 2: In Process Controls (IPCs) Methods And Equipment For USP In cGMPs
• Carrying out physiochemical IPCs at USP step
• Carrying out microbiological IPCs at USP step
• Carrying out biochemical IPCs at USP step
• Focus on sampling
Activity 3: IPCs in practice
• Applicative exercises and games to put into practice the knowledge from the previous learning elements.
• Module evaluation quiz
Prerequisites
Complete the modules 1, 2 and 3 of this curriculum, essential level, or having some basic knowledge of USP
Learning mode
Remote
Digital modalities
E-learning / Serious Game
Evaluation procedures
• A final evaluation at the last module to assess what you have learnt in the curriculum (max. 3 attempts, 80% of correct answers required)
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more.
Face to face training
Not Applicable
Contact for any question
Module Version Level & Date
Module 4 - Version Master Essential from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards.
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