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| Pharmaceutical Manufacturing (U.S.)
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Description:
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.
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- Facilities and Equipment
- Equipment Requirements
- Facility Requirements
- Introduction
- 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
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- Production Controls
- Batch Size, Components and Yield
- In-process Sampling and Testing
- Microbiological Control
- Reprocessing
- Written Procedures
- Recordkeeping
- Complaint Files
- Distribution Records
- Equipment Recordkeeping
- General Requirements
- Lab Records
- Labeling
- Production and Control Recording
- Production Record Review
- Validation
- Equipment Qualification
- Process Validation
- Test Validation
- Validation Documentation
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