Glossary

Control Strategy

A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.

Source · ICH Q10, Glossary, Control Strategy

Related sections

ICH Q10 §§1.5–1.8, 2–4 EU GMP Part I Chapter 1

Related terms

State of Control33 casesKnowledge ManagementQuality Risk Management (QRM)13 cases

Real inspection findings

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

  1. Furthermore, the company was not able to establish an appropriate endotoxin control strategy which could also potentially impact non-sterile APIs.
    EMA · EU GMP NCR (EudraGMDP) · 2026-01-30
  2. Five “Major” findings were identified related to qualification and control of gowning and garment cleaning processes, Contamination Control Strategy, management of Aseptic Process Simulations, Suppliers Approval system and management of the Quality Control laboratories.
    EMA · EU GMP NCR (EudraGMDP) · 2026-05-11
See 9 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

ICH Q10, Glossary, Control Strategy

GRM Regulatory Glossary

243 GMP terms in one place

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