Definition

Quality system and manufacturing standards that ensure products are consistently produced and controlled to the quality required for their intended use. Enforced by regulatory authorities.

Example

GMP covers premises, equipment, documentation, validation, and release; non-compliance can lead to warning letters or suspension.

Regulatory source

21 CFR 210/211, EU GMP (EudraLex Vol 4), ICH Q7

Common mistakes

Treating GMP as paperwork only; not embedding quality culture. Inadequate deviation and CAPA systems.

Inspector question

Describe your deviation and CAPA process. How do you prevent recurrence?

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