Change control is one of those areas where organisations tend to feel reasonably confident going into an inspection. The system is structured, the records are traceable, every change has been assessed and approved through a defined process. If you ask most quality teams whether their change control is working, the answer is usually yes, and they can point to the documentation to support it. What's harder to see is what those decisions look like in aggregate. The assumption bu

There's a version of process validation that most organisations are very familiar with. Protocols are written, PPQ batches are executed, data is reviewed, and a report is produced that formally declares the process validated. The file goes into the quality system, the process moves into routine manufacturing, and validation is considered done. The word "done" is where the problem starts. Validation isn't a certificate you receive at the end of a qualification exercise. It's a

In August 2022, the European Medicines Agency published the revised EU GMP Annex 1 on the manufacture of sterile medicinal products. The revision introduced one of the most significant documentation requirements the industry had seen in years: every sterile manufacturing site must develop and maintain a documented, risk-based Contamination Control Strategy (CCS). The requirement was clear. The path to meeting it was not. Most sites reached for what they knew: Word documents,