Why is Testing into Compliance Prohibited?

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“Testing into Compliance” — A Red Flag for FDA Inspectors

In pharmaceutical manufacturing, data integrity is non-negotiable.

Yet some companies still engage in the risky practice of testing into compliance — retesting until a passing result is found, while ignoring or discarding out-of-specification (OOS) results without proper scientific justification.

This practice is explicitly prohibited by the FDA and violates multiple tenets of Current Good Manufacturing Practice (CGMP).

Why Is It So Problematic?

Non-scientific:

  • Retesting without a valid hypothesis undermines the reliability of the data.

CGMP Violation:

  • CGMP requires that all data be considered unless invalidated through a documented investigation.

Data Integrity Breach:

  • Discarding OOS results without justification is considered data manipulation.

Ignores OOS Investigations:

  • FDA expects a full investigation into any OOS result — not a retest until it disappears.

What Does the FDA Expect?

Full Documentation:

  • Every test result, including OOS, must be recorded and retained.

Root Cause Analysis:

  • Investigate OOS results to determine if they stem from lab error, instrument failure, or true product failure.

Scientific Justification:

  • Only reject a test result if a scientifically sound reason is documented.

Use All Data:

  • All valid data must be included in calculations — cherry-picking is not allowed.

Consequences of Non-Compliance

FDA Inspections:

  • Inspectors are trained to detect this practice and will cite it as a violation.

Regulatory Action:

  • Warning letters, import alerts, and product recalls may follow.

Public Health Risk:

  • Adulterated or substandard products may reach patients, compromising safety.


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Resource Person: BARBARA PIROLA

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