Comparison of GMPs for Pharmaceuticals, APIs, and Medical Devices

NUS Academy of GxP Excellence


Course introduction

Introduction


Objective

This course provides an overview of the differences of Good Manufacturing Practice (GMP) requirements between pharmaceuticals, active pharmaceutical ingredients, and medical devices. Learning the differences will allow professionals from the medical device and pharmaceutical industries in Singapore to better cross-utilize resources, for example, persons with experience from one industry may adapt quicker to another industry.

Description

This course provides an overview of the differences in legal basis and GMP inspections between medical device manufacturers and pharmaceutical manufacturers that formed some of the fundamental differences in GMP enforcement and adaptation. The course will use US FDA and European Union regulations as the basis for the discussions. The US FDA and the EU are considered two of the most influential reference agencies in the world.

The course will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements.

Course Outline

• Introduction to Quality and Compliance Concepts
• Differences between Medical Devices and Pharmaceuticals
• Scope of the GMPs and the Quality Cycle
• Standards of Quality
• The Shifting Paradigm to Focus on Customer and User Satisfaction – The Quality Systems Approach
• Comparison of Definitions and Terms
• Comparison of Personnel and Management Expectations
• Comparing Design Requirements
• Comparing Master Records
• Comparing Equipment Controls
• Comparing Material and Incoming Controls
• Comparing the Control of Processes
• Packaging and Labeling Comparisons
• Laboratory Controls and Device Evaluation
• Holding, Distribution, & Returns
• Problem Solving-Deviations, Complaints, and CAPA
• Part 11
• Current Trends
• Review and Wrap-up

Learning Outcomes

Upon completion of this course the attendees will be able to:

1. Understand the major differences between medical device and pharmaceutical GMPs, from the standpoint of written regulations, enforcement, and compliance
2. Think about how the industries in Singapore can better share GMPresources



Fees & Funding

Please enquire below for course fees and financial grants:


 

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