“Testing into Compliance” is a phrase frequently encountered during GMP audits, regulatory inspections, FDA Form 483 observations, and Warning Letters. Across pharmaceutical and life sciences organizations, it continues to remain one of the most recurring data integrity concerns identified by inspectors and auditors
At the surface, repeated testing may appear scientifically cautious or operationally justified. However, from a regulatory perspective, the concern often extends far beyond laboratory execution.
Is “testing into compliance” merely a laboratory practice, or is it a broader reflection of GMP culture and integrity?
To understand why regulators view this issue seriously, it is important to first understand what the term truly means.
Testing into compliance typically occurs when:
- Multiple analyses are performed until a desired or passing result is obtained
- Out-of-specification (OOS) or atypical results are informally invalidated
- Retesting lacks scientifically justified rationale
- Data is selectively reported
For assessors, the concern is not always the number of tests performed. The real concern lies in:
- The intent behind the testing
- Whether predefined scientific procedures were followed
- Whether investigations were objective and properly documented
- Whether all generated data was evaluated transparently
When laboratories repeatedly test samples without scientific justification or robust investigation, and regulators identify a pattern of practice, the reliability of the entire Pharmaceutical Quality System (PQS) may come into question.
However, the question then is whether all “retesting then is considered inappropriate”?
The simple answer is a “NO”
Retesting may be scientifically justified and accepted provided
- There is a documented laboratory error
- Instrument malfunction has been confirmed
- Sample preparation issues are identified
- Method execution deviations are proven
- Predefined retesting criteria are followed
What is the most critical to the process is whether
- The investigation is objective
- The rationale is scientifically justified and documented
- The process is predefined within approved procedures
- All results are evaluated transparently
- Scientific reasoning, not business pressure which drives the decision
A compliant retest should seek the truth whereas Testing into compliance could seek for a passing result.
One of the most overlooked dimensions of testing into compliance is “INTENT”. Inspectors / auditors will not look for what happened by “why it happened”
Building a Culture That Prevents Testing Into Compliance is the key and it requires more than just procedural updates and trainings, for example
- Training on intent and ethics. A clear understanding of how selective testing could be perceived and what are its implication, the relationship between intent and misconduct
- Promoting data transparency
- Strengthening of OOS investigation
- Establishing clear retesting policy