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Pharmaceutical Manufacturing (U.S.)


Our Pharmaceutical Manufacturing (U.S.) test measures your knowledge of all aspects of pharmaceutical manufacturing in the United States. Designed for professionals with pharmaceutical manufacturing experience, this test covers the following topics: Packaging Controls, Laboratory Controls, Record Keeping, Holding and Distribution, Facilities and Equipment, and Validation.


Once you request a test, your Personal Identification Number (PIN) will be stored in your My Plan for easy access. You will have 90 days in which to take the test you requested.

Test Outline

Facilities and Equipment
Equipment Requirements
Facility Requirements
General Provisions
Personnel Requirements
Quality System Requirements
Laboratory Controls
Final Testing and Release
General Requirements
Holding and Distribution
Raw Material Testing
Receipt and Testing
Rejected Materials
Reserve Samples
Special and Stability Testing
Packaging Control
Component and Closure Control
Containers/Closures and Tamper-Resistant Packaging
Expiration Dating
Labeling Acceptance and Issuance
Labeling and Packaging Operations
Product inspection
Production Controls
Batch Size, Components and Yield
In-process Sampling and Testing
Microbiological Control
Written Procedures
Complaint Files
Distribution Records
Equipment Recordkeeping
General Requirements
Lab Records
Production and Control Recording
Production Record Review
Equipment Qualification
Process Validation
Test Validation
Validation Documentation