CMC & Manufacturing

Deviation

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

Usage Examples

A deviation was opened for the temperature excursion.
Investigation determined the deviation had no impact on quality.
Deviation trending identified a training gap.

What is Deviation?

A deviation is any departure from approved instructions, procedures, specifications, or established standards. Deviations can occur during manufacturing, testing, storage, or distribution and may affect product quality.

Deviations must be documented, investigated, and assessed for impact. Investigation determines root cause, affected batches, and necessary corrective actions. Critical deviations affecting product quality may require batch rejection or regulatory notification.

A robust deviation management system includes categorization (critical/major/minor), timely investigation, CAPA implementation, and trending to identify systemic issues.

Regulatory Context

This term appears most often in cmc & manufacturing workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 211, EU GMP.

FDAICHHealth Canada

When This Matters

A deviation was opened for the temperature excursion.
Investigation determined the deviation had no impact on quality.
Deviation trending identified a training gap.

Common Mistakes

Failing to align CMC change narratives with current CFR/ICH expectations.
Submitting incomplete control strategy documentation.
Separating manufacturing and regulatory review cycles too late in execution.

Related Regulations

21 CFR 211EU GMP

Frequently Asked Questions

A planned deviation is a pre-approved, intentional departure from standard procedures, typically for process improvement evaluation or non-routine activities. It still requires documentation and risk assessment.

Typically as Critical (potential patient safety impact), Major (significant GMP departure), or Minor (minimal quality impact). Categories determine investigation depth and escalation requirements.