PIC/S Premises, Facilities & Equipment

An overview of PIC/S GMP requirements for pharmaceutical premises, facilities, production areas, storage areas, equipment, utilities, cleaning, maintenance, qualification, and contamination control.

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Course Content

Module 1: GMP Premises & Facility Fundamentals
  • 1. PIC/S Requirements for Premises
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  • 2. GMP Facility Design Principles
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Module 2: Manufacturing & Storage Areas
  • 1. Production Areas
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  • 2. Storage Areas
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Module 3: Contamination & Cross-Contamination Control
  • 1. Sources of Contamination
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  • 2. Basic Contamination Controls
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Module 4: GMP Equipment
  • 1. Equipment Requirements
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  • 2. Equipment Operation & Control
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Module 5: Utilities, Maintenance & Calibration
  • 1. GMP Utilities Overview
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  • 2. Maintenance & Calibration
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Module 6: Facility & Equipment Lifecycle Control
  • 1. Qualification Overview
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  • 2. Maintaining a State of Control
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Final Assessment
Complete all modules to unlock final exam