Change control: why switching bottles takes months
In most industries, changing packaging supplier is a purchasing matter. In the pharmaceutical industry, it is a file, tests and sometimes an approval. The bottle is part of the authorised medicine.
By Tecmom editorial team · 2 min read
The bottle is part of the file
Immediate packaging, the part that touches the medicine, is described in the marketing authorisation file: its material, its shape, its closure. The stability studies were run with it. Changing it means changing what was authorised.
That is why a laboratory does not replace one bottle with another that looks equivalent on paper. It must show that the new one protects the medicine at least as well, which means tests, and often months of stability data.
A variation, light or heavy
In the European Union, a change to an authorised medicine is a variation. It is classified according to its possible effect on quality: a simple notification for minor changes, prior approval for the more significant ones. For a sterile medicine, a change of immediate packaging is generally a major variation.
The framework has been revised: new guidelines have applied since 15 January 2026. The European Medicines Agency has also revised its guideline on the stability studies required for variations. Climatic zones set the conditions for these studies.
Change control, on the laboratory side
The ICH Q10 guideline describes the pharmaceutical quality system, of which change management is a central element. Before any change, its possible effect on product quality is assessed, the necessary tests are decided, the change is approved, and afterwards it is checked that it had the intended effect.
For packaging, the assessment covers compatibility, sealing, barrier, extractables and leachables, and performance on filling lines.
What the supplier owes
A change can also come from the supplier: a new material grade, a new colourant, a repaired or replaced mould, a move to another machine. The quality agreement between the laboratory and its packaging manufacturer specifies which changes must be notified, and with how much notice.
The ISO 15378 standard requires manufacturers of primary packaging materials to control their own changes and inform their customers. A change discovered after the fact costs far more than one announced in advance.
Changing a bottle takes months because the bottle is not an accessory to the medicine. It is part of it, and it is changed with the same care.
Glossary
- Variation
- A change to the terms of a marketing authorisation.
- Change control
- The process that assesses, approves and verifies any change that may affect quality.
- ICH Q10
- The international guideline on the pharmaceutical quality system.
- Quality agreement
- An agreement that divides quality responsibilities between a laboratory and its supplier.