GMP and validation — the quality system behind pharmaceutical manufacturing
Why every single tablet that leaves the factory can be traced back to the exact process that made it
GMP stands for Good Manufacturing Practice, in Danish god fremstillingspraksis. It is the collection of rules and principles that ensure that medicines are manufactured uniformly and under control, every single time. In Denmark, the requirements are set out in the Medicines Agency's GMP Regulation — Regulation no. 1358 of 18 December 2012 on the manufacture and importation of medicinal products and intermediates — which is based on common EU rules.
§What does GMP require in concrete terms?
- 01Written procedures (SOPs) for virtually all work, so it is performed the same way each time
- 02Trained and continuously qualified staff for each task.
- 03Documented history for each individual batch
- 04Physical or procedural separation that prevents cross-contamination between products
- 05A quality function independent of production itself
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§Validation and qualification — IQ, OQ, PQ
The regulation on process operator training explicitly requires that students have thorough knowledge of applicable standards for validation and qualification in the pharmaceutical and food industry. In practice, equipment qualification typically takes place in three stages that build on each other.
| Step | Questions to be answered |
|---|---|
| IQ – installation qualification | Has the equipment been delivered and installed correctly and does it match the specification? |
| OQ — operational qualification | Does the equipment work as expected within the set limits? |
| PQ — process performance qualification | Does the equipment consistently deliver the correct result under real operating conditions over time? |
§Batch documentation and deviations
Each batch is followed by its own batch log, where all process steps, measured values and controls are documented as they happen. If anything deviates from the planned process, a deviation report must be prepared that assesses what happened, why, and what it means for the batch — before the batch can even be considered for release.
“In pharmaceutical production, documentation is not proof that the work was done properly — it is part of making sure it is.”