EU GMP Annex 15 expects the key elements of a validation program to be defined in a validation master plan or an equivalent document. It typically covers scope, responsibilities, the systems, equipment and processes to be validated, the validation strategy, documentation, change control and periodic review. Many companies keep a system inventory alongside it.

Why it matters for labeling

Any computerized system used for labeling, such as artwork management, comparison and approval tools, belongs in the validation scope. The VMP shows an inspector that these systems are known, risk-assessed and governed, and it makes clear what is covered by a vendor's validation documentation and what the company has to do itself. The individual IQ, OQ and PQ protocols sit beneath it.

Common mistakes

  • A plan that is out of date or no longer reflects the systems in use
  • Labeling tools missing from the system inventory
  • No link between the plan and the risk assessments
  • Copying a plan from another site without adapting it

Sources