GDP for Pharma: Good Distribution Practice & Inspections

This course contains the use of artificial intelligence.
AI is used to reframe the words, fixing spelling mistakes and grammatical mistakes and audio conversion.

There are two kinds of pharmaceutical warehouse. One works well. The other works well and can prove it. The difference between them is roughly a week of an inspector's time, and it is the whole subject of this course. Good Distribution Practice governs how medicines are stored, handled and moved from the manufacturer to the patient. If you hold a wholesale distribution licence, or you work for somebody who does, it is not optional and it is not abstract — it is what you do at goods-in on a Friday afternoon when a driver is waiting and the temperature record has not arrived.

Most training on this subject walks the ten chapters of the European guideline in order. That is a reasonable way to read a document and a poor way to learn a job. Published inspection data covering more than a thousand deficiencies shows where problems actually cluster: quality systems first, then transportation, then the Responsible Person. This course is built in that order. Every one of the ten chapters is covered, but you meet them where they matter rather than where they sit in the contents page. You will work through the quality system an inspector actually tests, including deviations that get under-reported and corrective actions that close without anybody checking they worked. You will spend a full section on premises and temperature mapping — how many sensors, for how long, why summer and winter are both required, and how the mapping study tells you where to place permanent monitoring. You will handle a temperature excursion from the alarm at six on a Sunday morning through quarantine, data gathering, mean kinetic temperature and the release decision. You will run returns, a recall, a mock recall designed to fail, and a traceability test. And you will prepare for, sit through and respond to an inspection.

I teach this from the operations side. I have run warehouse and distribution operations including pharmaceutical sites for twenty years, and I have been on the floor during inspections rather than in the meeting room afterwards. I am not a Responsible Person and I do not pretend to be. Where a decision belongs to a qualified person, I say so, and I teach you how to work with them well. This is training, not legal advice, and it does not certify you. Content is current as of September 2026, and the final section covers what is changing and how to check the position yourself. Start with Section 1.