Programme Scope

What this test series covers

GMP personnel responsibilities, Training requirements, Hygiene standards, Qualification of key personnel, GMP awareness — foundational GMP domain.

GMP facility design, HVAC, Clean room classification, Equipment qualification (IQ/OQ/PQ), Water systems (WFI/PW), Environmental monitoring.

Batch Manufacturing Records, SOPs, Change control documentation, Out-of-specification investigations, CAPA documentation — GMP document management.

Manufacturing process requirements, In-process controls, Contamination prevention, Packaging and labelling controls, Process validation under FDA/WHO/ICH Q8.

QC testing requirements, Stability testing (ICH Q1), Reference standards, Laboratory OOS investigations, QA audit responsibilities.

Process validation (FDA/ICH Q10), Computer system validation (21 CFR Part 11/EU Annex 11), Cleaning validation, Change control procedures.

Learning Objectives

What this test series achieves

To assess GMP certification readiness across all quality system domains through timed MCQ examinations aligned to WHO GMP, FDA 21 CFR, and ICH Q10 standards

To master documentation and change control MCQs — BMR/BPR requirements, SOP management, CAPA documentation, and deviation handling under GMP

To develop validation and qualification competency — process validation, computer system validation (21 CFR Part 11/Annex 11), cleaning validation, and qualification protocols

To build premises and equipment GMP knowledge — clean room design, HVAC, equipment qualification, water systems, and environmental monitoring

To identify topic-level GMP knowledge gaps using AURA analytics calibrated to WHO/FDA/ICH GMP quality system standards

To track readiness with a real-time GMP certification Pass Probability Score updated after every session

To reinforce QC and stability testing MCQs — ICH Q1 stability zones, OOS investigation procedures, and laboratory GMP requirements

To benchmark GMP performance against a global pharmaceutical industry cohort preparing for GMP certification

Target Audience

Who can enrol

Programme Certification

Your certificate