In GxP environments, a change to a process, system, specification or document is assessed for its impact, approved by the right people, implemented in a controlled way, and recorded with the reason. EU GMP Annex 11 includes a clause on change and configuration management for computerized systems, and ICH Q10 describes a change management system as part of a pharmaceutical quality system.

Why it matters for labeling

Every label revision is a change. Without change control, an edit can reach a production file without being reviewed again, or be approved against a version that no longer exists. A good process states what is changing and why, which markets and variants are affected, who has to re-review, and what the released version is.

Common mistakes

  • Late changes applied directly to near-final artwork without re-review
  • Changes made to one language version or packaging level but not the others
  • No recorded reason for a change
  • No check that the released file matches the approved change

Sources