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,

Fragrance sells product, but it also drives some of the most complex labelling and formulation work you'll do in 2025 and beyond. Europe has expanded the list of fragrance allergens that must be named on labels when present above set thresholds, Great Britain hasn't (yet) mirrored those changes, and the U.S. is moving toward its own disclosure rule under MoCRA. Read on for a clear, practical path through the moving parts so you can plan reformulation , labelling, and artwork