Glossary

Control Strategy

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

Related sections

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

Related terms

State of Control32 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
  3. In your response, we acknowledge your intentions to strengthen investigation requirements, perform a retrospective review of investigations, and review the facility’s contamination control strategy.
    FDA · FDA Warning Letter · 2026-09-01
See 9 findings that mention this term

Source

ICH Q10, Glossary, Control Strategy
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