🧪 Analytical Testing Errors That Can Cost You an FDA/EMA Approval

Introduction to Analytical Testing Errors

In the world of pharmaceuticals, analytical testing is the backbone of every regulatory submission. Whether it’s an ANDA, NDA, DMF, or export dossier, your testing data determines whether your product reaches the global market — or gets rejected.

And here’s the truth: Most FDA/EMA rejections are not because the product fails… but because the testing fails.

From data integrity lapses to incomplete validation, small analytical mistakes can trigger major regulatory consequences.

1.) Poor Method Validation

FDA and EMA expect analytical methods to be validated as per ICH Q2(R1). Analytical Testing Errors Even one missing parameter (accuracy, precision, specificity, linearity, robustness) can result in:

• Submission delays

• Requests for additional data

• Complete rejection of results

Fix: Partner with ISO 17025 labs that perform complete, traceable validation.

2.) Data Integrity Failures (Biggest Red Flag)

Regulators now have zero tolerance for data manipulation or missing raw data.

Common violations include:

• Shared logins

• Missing audit trails

• Manual data overwriting

• Uncontrolled spreadsheets

• No LIMS system

Fix: Follow ALCOA+ and ensure all testing is LIMS-driven with secure audit trails.

3.) Incorrect or Unqualified Reference Standards

Using expired, non-certified, or non-traceable standards directly impacts test accuracy.

A single wrong CRM linkage can invalidate your entire study.

Fix: Use ISO 17034–certified reference materials with full traceability.

4.) Improper Stability Testing

Stability studies are among the most common parts of an ANDA/DMF rejected due to:

• Chamber excursions

• Missing timepoint data

• Non-stability-indicating methods

• Poor documentation

Fix: Use validated stability chambers and stability-indicating methods (SIMs).

5.) Incomplete OOS / OOT Investigations

Nothing raises FDA suspicion faster than:

• Poorly documented OOS

• Incomplete root cause

• No corrective action documentation

Fix: Follow FDA OOS guidance with structured investigation procedures.

Conclusion

Analytical errors are preventable — but costly if ignored. By choosing a NABL-accredited, ISO 17025–compliant, data-integrity-driven testing partner like Hetero Analytical Solution LLP, you eliminate avoidable risks and ensure your submissions are audit-ready, accurate, and globally accepted.