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Parental product inspection

This course provides participants with a comprehensive understanding of Parenteral Product Inspection in accordance with Good Manufacturing Practices (GMP), current regulatory requirements, and international standards for sterile pharmaceutical products. The course focuses on the inspection of injectable products throughout manufacturing and before batch release to ensure product sterility, integrity, safety, and compliance with quality specifications.

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# Content
1 Module 1: Introduction to Parenteral Product Inspection
2 Module 2: Regulatory Requirements
3 Module 3: Critical Quality Attributes (CQAs)
4 Module 4: Visual Inspection Principles
5 Module 5: Defect Identification and Classification
6 Module 6: Automated Inspection Systems
7 Module 7: Container Closure Integrity (CCI)
8 Module 8: Sampling and Acceptance Criteria
9 Module 9: Documentation and Record Keeping
10 Module 10: Deviations, Investigations, and CAPA
11 Module 11: Inspection Readiness
12 Module 12: Practical Workshops and Case Studies
# Outcomes
• Explain the principles and importance of parenteral product inspection.
• Identify critical quality attributes (CQAs) of sterile injectable products.
• Detect visible particles, container defects, and packaging defects during inspection.
• Perform visual inspection using standardized inspection techniques.
• Operate and evaluate automated inspection systems.
• Apply defect classification and product acceptance criteria.
• Verify container closure integrity using appropriate methods.
• Maintain complete inspection documentation and traceability.
• Investigate inspection deviations and non-conforming products.
• Demonstrate compliance with GMP and international regulatory requirements.
# Participants
1
• Quality Control (QC) Inspectors and Analysts
2
• Quality Assurance (QA) personnel
3
• Sterile Manufacturing Operators
4
• Visual Inspection Operators
5
• Production Supervisors and Managers
6
• Microbiology Laboratory personnel
7
• Validation and Qualification Specialists
8
• Packaging and Inspection personnel
9
• Manufacturing Engineers
10
• Engineering and Maintenance personnel
11
• Regulatory Affairs professionals
12
• Internal Auditors
13
• Pharmaceutical and Biotechnology professionals involved in sterile product manufacturing
14
• Anyone responsible for the inspection, release, or quality assurance of parenteral products