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PIC/S API GMP – Active Pharmaceutical Ingredients

PIC/S GMP principles for active pharmaceutical ingredients covering quality management, personnel, facilities, equipment, materials, production, laboratory controls, validation, change control, storage and distribution.

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Course Content

Module 1: API GMP Fundamentals
  • 1. Understanding APIs
    Locked
  • 2. PIC/S Part II Overview
    Locked
Module 2: Quality Management & Personnel
  • 1. API Quality Management
    Locked
  • 2. Personnel & Training
    Locked
Module 3: Facilities, Equipment & Materials
  • 1. Buildings & Process Equipment
    Locked
  • 2. Materials Management
    Locked
Module 4: API Production & Process Control
  • 1. Production Operations
    Locked
  • 2. Reprocessing, Reworking & Contamination Control
    Locked
Module 5: Laboratory Controls & Validation
  • 1. API Laboratory Controls
    Locked
  • 2. Qualification & Validation
    Locked
Module 6: Change Control, Storage & Supply Chain
  • 1. Change Control & API Lifecycle
    Locked
  • 2. Storage, Distribution & Traceability
    Locked
Final Assessment
Complete all modules to unlock final exam
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