GMP Pharmaceutical Quality
Pharmaceutical quality: GMP concepts, how an inspector asks, and real inspection cases.
GMP Concepts
22 episodes
Ep. 1 · 2026-10-24
Pharmaceutical Quality System, Explained
Three maps to see how a pharmaceutical quality system works.
Ep. 2 · 2026-10-30
Quality Risk Management
Risk is uneven: two principles and one process for spending effort where it matters.
Ep. 3 · 2026-11-02
Documentation, Explained Once and for All
The medicine passed testing, so why keep records? Two kinds of documents, ALCOA+, three media.
Early release · 2026-10-19
Computerized Systems, Explained in One Go Early release
Why the audit trail stays on: computerized systems in GMP, from the top.
Ep. 4 · Expected Nov 05, 2026
Qualification and ValidationTentative
Ep. 5 · Expected Nov 08, 2026
PersonnelTentative
Ep. 6 · Expected Nov 11, 2026
Premises and EquipmentTentative
Ep. 7 · Expected Nov 14, 2026
ProductionTentative
Ep. 8 · Expected Nov 17, 2026
Quality ControlTentative
Ep. 9 · Expected Nov 20, 2026
Sterile Products (1): Contamination Control and CleanroomsTentative
Ep. 10 · Expected Nov 23, 2026
Sterile Products (2): Aseptic Process Simulation and Environmental MonitoringTentative
Ep. 11 · Expected Nov 26, 2026
Authorised Person and Batch ReleaseTentative
Ep. 12 · Expected Nov 29, 2026
Reference and Retention SamplesTentative
Ep. 13 · Expected Dec 02, 2026
Outsourced ActivitiesTentative
Ep. 14 · Expected Dec 05, 2026
Complaints and Product RecallTentative
Ep. 15 · Expected Dec 08, 2026
Self-InspectionTentative
Ep. 16 · Expected Dec 11, 2026
Change Control, Deviations and CAPATentative
Ep. 17 · Expected Dec 14, 2026
Active Pharmaceutical Ingredients (Part II)Tentative
Ep. 18 · Expected Dec 17, 2026
Biologics and ATMPsTentative
Ep. 19 · Expected Dec 20, 2026
PIC/S, FDA and NMPA: Three GMP Systems ComparedTentative
Ep. 20 · Expected Dec 23, 2026
GMP You Need on Your First Day in a Pharma PlantTentative
Ep. 21 · Expected Jan 01, 2027
GMP × Project Management: Seeing GMP Through a Project Manager's Eyes (TBD)Tentative
How a GMP Inspector Would Ask
8 episodes
· 2026-10-24
Why Did One Acne Lotion Spark Four FDA Questions?
No benzene test before release, and an FDA inspector's four questions.
· 2026-10-31
A "Fully Sealed" Wall. So How Did the Drug Get Across?
Segregation was built, yet cephalosporin still showed up beyond the wall.
Expected Nov 03, 2026
Unclaimed Raw Data Found in a Shred BinTentative
Expected Nov 06, 2026
Nearly Every Validation Cycle Grew Bacteria. Why Did It Still "Pass"?Tentative
Expected Nov 09, 2026
Smoke Too Thin to See, Yet Airflow Rated "Excellent"?Tentative
Expected Nov 12, 2026
A Ceiling That Is Neither Waterproof Nor Cleanable, in an Aseptic Filling RoomTentative
Expected Nov 15, 2026
Batch Record Says 12 Interventions; Reality Was About 200Tentative
Expected Nov 18, 2026
The Same Test Run 11 Times, None of It RecordedTentative
FDA 483 Case
8 episodes
· 2026-10-24
An 18 mm Piece of Glass in a Vial
Glass in a vial, two complaints, and no root cause found.
· 2026-10-29
Cleared to Ship Before the Tests Are Done
The release procedure let batches ship early, but never said what happens if a test fails.
· 2026-11-01
Fill Volume Set by a Recipe That Was Never Validated
Fill volume was controlled by electronic recipes that were never validated.
Expected Nov 04, 2026
Glass, Black Fibers and Hair Barely Detected, Yet the Total "Passes"Tentative
Expected Nov 07, 2026
One Plasmid Reference, Three Reports, Three Different SizesTentative
Expected Nov 10, 2026
Condensation Everywhere, So No One Could See a Leaking BagTentative
Expected Nov 13, 2026
Rework on the Packaging Line, Without Quality KnowingTentative
Expected Nov 16, 2026
80 Bacterial Isolates, 8 Batches Rejected, Still "No Impact on Quality"Tentative
