Why Certificate of Analysis (COA) Errors Pharma Lead to Export Shipment Rejections

Why Certificate of Analysis (COA) Errors Pharma Lead to Export Shipment Rejections

For pharmaceutical exporters, a Certificate of Analysis (COA) error pharma is more than a document — it is a passport for global market entry. Even when a product meets all quality specifications, a single COA error can result in shipment holds, rejections, or regulatory scrutiny.

In today’s regulatory environment, authorities such as FDA, EMA, WHO, and importing country regulators carefully review COAs to verify product quality, traceability, and data integrity.

Unfortunately, COA-related issues remain one of the top reasons for export shipment rejections.

Why COAs Are Closely Scrutinized

A COA confirms that a batch:

• Meets approved specifications

• Has been tested using validated methods

• Uses traceable reference standards

• Is supported by accurate and complete data

Regulators rely on the COA to decide whether a shipment is safe, compliant, and acceptable for entry.

If confidence in the COA is lost, the shipment is at risk — regardless of product quality.

Top COA Errors That Trigger Export Rejections

1️⃣ Inconsistent or Incorrect Test Results

Differences between:

• COA results and batch records

• COA and stability data

• COA and regulatory filings

raise immediate red flags.

🔹 Impact: Shipment held for clarification or rejected.

2️⃣ Missing Method and Specification References

COAs that do not clearly mention:

• Test methods

• Pharmacopoeia references

• Approved specifications

are considered incomplete.

🔹 Impact: Regulator questions validity of results.

3️⃣ Use of Non-Traceable Reference Standards

Failure to document:

• Certified Reference Materials (CRMs)

• Lot numbers and expiry

• Traceability to international standards

undermines result reliability.

🔹 Impact: Entire COA may be declared invalid.

4️⃣ Data Integrity Gaps

Common findings include:

• No audit trail

• Manual data entry without verification

• Inconsistent formatting or signatures

🔹 Impact: Loss of trust in laboratory data.

5️⃣ COA Issued by Non-Accredited Laboratories

COAs generated by labs without ISO 17025 or NABL accreditation often face rejection in regulated markets.

🔹 Impact: Additional testing or re-analysis required at importer’s cost.

How to Prevent COA-Related Export Rejections

To ensure COAs are accepted globally, exporters should:

• Use NABL-accredited, ISO 17025-compliant laboratories

• Ensure all methods are validated and referenced

• Maintain full traceability of standards and instruments

• Implement ALCOA+ data integrity principles

• Review COAs thoroughly before shipment release

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How Hetero Analytical Ensures Export-Ready COAs

At Hetero Analytical Solution LLP, we support pharma exporters with:

• ISO 17025:2017-accredited testing

• NABL-recognized analytical reports

• CRM-based traceable testing

• Secure LIMS-driven data management

• Clear, regulator-accepted COA formats

Our COAs are designed to withstand regulatory review — not just pass internal checks.

Conclusion

Most export rejections are not caused by product failure — they are caused by documentation failure. A strong, accurate, and compliant COA protects your shipment, your timelines, and your reputation.

When it comes to exports, your COA must speak the regulator’s language — clearly and confidently.