Regulatory Compliance Inspections and External Audits

Compliance with guidelines established by regulatory agencies such as the WHO or the FDA is a key aspect of Good Manufacturing Practice (GMP). It is enforced by inspections and audits: inspections evaluate two or more systems in the manufacturing loop; audits confirm that the goals of GMP are being met.

In this introduction to the inspection and auditing processes, participants will learn about various types of inspections and about the role of regulatory bodies in ensuring the production of safe and effective drugs and medical devices.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: Why are Regulatory Compliance Inspections and External Audits Important?

Lesson 2: The ICH Q10 Guidelines on Regulatory Inspections

• Achieve Products Realization
• Establish and Maintain a State of Control
• Facilitate Continual Improvement

Lesson 3: Which Businesses are Subject to Compliance Inspections and External Audits?

Lesson 4: Who Monitors and Audits GMP Compliance?

• Regulatory agencies responsible for GMP Audits

Lesson 5: Types of Regulatory Compliance Inspections

• Routine Inspection
• Concise Inspection
• Follow-up Inspection
• Special Inspection
• Quality Systems Review
• Frequency of Inspections

Lesson 6: FDA Guidelines for Compliance Inspection and Audit Strategy

• Quality system
• Inspection of Quality System (Phase 1 and Phase 2)
• Product Reviews
• Compliant Reviews
• Discrepancy and Failure Investigations (for manufacturing and testing)
• Change Control
• Product Improvement Projects
• Reprocessing
• Market Returns
• Rejects
• Stability Failures
• Validation
• Staff Training
• Facilities and Equipment System
• Inspection of Facilities and Equipment System
• Facilities
• Equipment
• Materials System
• Production System
• Packaging and Labeling System
• Laboratory Control System

Glossary

Quiz