GMP 101: The Quality and Compliance Podcast

(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

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