Introduction to GMP101

Introduction to GMP101 (Trailer)

(this is the correct audio version) 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

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