Glossary

Validation Master Plan (VMP)

The high level document summarising a site's qualification and validation policy, organisation, scope, status, and strategy.

Related sections

EU GMP Annex 15 §§1–4 EU GMP Annex 11 §4

Related terms

Validation2,555 casesValidation Protocol14 casesValidation Report14 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. For the batches of aseptic VMPs produced in Unit B, a recall class III on specific batches is issued by the Dutch Competent Authority (NL), based on the provided assessment of PM (process monitoring, including person monitoring) on batch-level.
    EMA · EU GMP NCR (EudraGMDP) · 2026-04-21
  2. You failed to adequately validate your cleaning process for non-dedicated manufacturing equipment as required by your Validation Master Plan.
    FDA · FDA Warning Letter · 2022-02-15
See 3 findings that mention this term

Source

EU GMP Annex 15, §§1.4–1.5, Validation Master Plan
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