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Pharmaceutical Mfg. Regulations (U.S.)
Description:
Our Pharmaceutical Mfg. Regulations (U.S.) test measures your knowledge of the regulations that govern pharmaceutical manufacturing in the United States. Designed for professionals with pharmaceutical manufacturing experience, this test covers the following topics: U.S. FDA Regulations, Buildings and Facilities, Process Control, Packaging and Labeling, Raw Materials, Equipment, Organization, and Records. This test will verify an individual's knowledge of the concepts and subjects tested. The results of this test do not imply that the individual possess the necessary skills to perform a specific procedure, nor treatment, nor is licensed, nor authorized, to practice any health care profession under any applicable laws.
Test Outline

Buildings and Facilities
Air Handling Systems
Building Services
Design
Documentation
Batch Records, Deviations
SOPs
Equipment
Design and Construction
Maintenance, Cleaning, Automated
Laboratory
Stability Testing
Testing and Release
Organization
Qualifications
Responsibilities
Packaging and Labeling
Examination and Issuance
Operations
Process Control
Contamination
Sampling
Raw Materials
Requirements
Testing and Approval
Records
General Requirements
Processing Records
US FDA Regulations
Applications of Regulations
cGMP Regulations