Introduction to GMP101

SECTION 1 — PIC/S FOUNDATION

• What is PIC/S?
• Why PIC/S matters globally
• Structure of PIC/S guidance
• Relationship between PIC/S, EU GMP, WHO, ICH
• How PIC/S inspections actually work

SECTION 2 — QUALITY MANAGEMENT SYSTEM

• QMS Fundamentals
• Management oversight & leadership
• Pharmaceutical Quality System (ICH Q10 alignment)
• CAPA & Deviations
• Root Cause Analysis & investigation science
• Change Control & risk impact assessments
• Product Quality Review (PQR / APR)

SECTION 3 — PREMISES & EQUIPMENT

• Facility design principles (flows, zoning, segregation)
• Cleanroom classifications & EM
• HVAC & differential pressures
• Equipment qualification (IQ/OQ/PQ)
• Calibration, maintenance & instrument control

SECTION 4 — PRODUCTION & OPERATIONS

• Documentation controls (GDP & Data Integrity)
• Batch manufacturing records
• Contamination control
• Line clearance
• Material management & traceability
• Packaging and labeling
• In-process controls

SECTION 5 — QUALITY CONTROL

• QC sampling and method validation
• Stability programs
• Out of Specification (OOS)
• Out of Trend (OOT)
• Lab data integrity

SECTION 6 — VALIDATION & QUALIFICATION

• Process Validation lifecycle
• Cleaning validation
• CSV & Annex 11
• Spreadsheets & hybrid systems

SECTION 7 — ANNEX 1 STERILE MANUFACTURING

• Aseptic processing
• CCS — contamination control strategy
• Environmental monitoring
• Media fills
• Personnel qualification
• Gowning

SECTION 8 — DATA INTEGRITY

• ALCOA+
• Data lifecycle
• DI risk assessments
• Human error reduction

SECTION 9 — INSPECTION READINESS

• How inspectors think
• Common PIC/S findings
• Interview techniques during inspection
• How to prepare staff
• Inspection room logistics
• Evidence presentation
• Mock inspection program