CGMP Practice Exam
CGMP Practice Exam
About CGMP Exam
The CGMP Practice Exam is designed to test your understanding of Current Good Manufacturing Practices followed in the pharmaceutical, food, and biotechnology industries. It covers quality control, documentation, hygiene, validation processes, and compliance with global regulatory standards. This exam helps students and professionals prove their knowledge of safe and controlled manufacturing environments.
Who Should Take the Exam?
This exam is suitable for:
- Students of pharmaceutical sciences, biotechnology, or chemical engineering
- Quality control and quality assurance professionals
- Production staff working in GMP-certified facilities
- Regulatory and compliance officers
- Trainers and faculty members in pharmaceutical or food manufacturing
- Anyone preparing for CGMP-related certifications or job interviews
Skills Required
- Basic understanding of manufacturing processes
- Awareness of quality control and assurance concepts
- Familiarity with GMP documentation and hygiene practices
- Knowledge of regulatory standards (e.g., US FDA, WHO, EMA)
- Attention to safety, cleanliness, and controlled conditions
Knowledge Gained
- Understanding of CGMP principles and why they are important
- Knowledge of production, packaging, and testing standards
- Familiarity with SOPs, documentation systems, and record-keeping
- Ability to identify non-compliance and risk factors
- Insights into validation, audits, and inspection procedures
- Understanding of roles in quality assurance and regulatory affairs
Course Outline
The CGMP Exam covers the following topics -
Domain 1 – Introduction to CGMP and Regulatory Agencies
- Importance of CGMP in manufacturing
- Overview of regulatory bodies like US FDA, WHO, EMA
Domain 2 – CGMP in Manufacturing Processes
- Cleanroom practices and environmental control
- Equipment handling and process validation
Domain 3 – Quality Control and Quality Assurance
- Role of QC and QA in CGMP
- Good Laboratory Practices (GLP)
Domain 4 – Documentation and Record Keeping
- Standard Operating Procedures (SOPs)
- Batch records, audit trails, and data integrity
Domain 5 – Personal Hygiene and Facility Sanitation
- Employee hygiene standards
- Cleaning and sanitization of manufacturing areas
Domain 6 – Storage, Labeling, and Packaging
- Controlled storage and inventory management
- Correct labeling and packaging procedures
Domain 7 – Inspections and Audits
- Internal audits and mock inspections
- How to prepare for regulatory audits
Domain 8 – Risk Management and Compliance
- Detecting non-compliance and managing deviations
- CAPA (Corrective and Preventive Actions)
