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PIC/S Quality Control & Laboratory GMP

An overview of PIC/S GMP requirements for pharmaceutical quality control laboratories, sampling, specifications, analytical testing, laboratory equipment, documentation, data integrity, OOS results, stability programs, reference samples, and inspection readiness.

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Course Content

Module 1: Introduction to Quality Control
  • 1. Role of Quality Control
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  • 2. PIC/S Quality Control Requirements
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Module 2: Sampling & Specifications
  • 1. GMP Sampling
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  • 2. Specifications
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Module 3: Laboratory Testing
  • 1. Analytical Testing
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  • 2. Laboratory Equipment & Instruments
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Module 4: Laboratory Documentation & Data
  • 1. Laboratory Records
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  • 2. Laboratory Data Integrity
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Module 5: OOS, Stability & Reference Samples
  • 1. Out-of-Specification Results
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  • 2. Stability & Reference Samples
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Module 6: QC Oversight & Inspection Readiness
  • 1. QC Review and Quality Decisions
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  • 2. Laboratory Inspection Readiness
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Final Assessment
Complete all modules to unlock final exam
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