EPCIS Data Errors in Pharma: Why Trading Partner Data Fails and How to Fix It
By Covectra | Posted on October 28, 2026
When EPCIS data doesn't match what a receiving trading partner expects or what physically arrives, shipments can be delayed until the discrepancy is corrected. Under Healthcare Distribution Alliance (HDA) guidelines, the receiving partner reports the issue and works with the sender to resolve it.
For manufacturers, EPCIS data errors can disrupt shipping operations and create compliance concerns. A flagged shipment may need to be held until the problem is cleared, and some corrections must be made by the sender. By identifying the exceptions customers report most often and tracing them to their source, manufacturers can respond faster and prevent similar errors before products ship.
Key Takeaways
- Exceptions remain common. In a 2025 survey, 55% of manufacturers and distributors reported receiving data without the corresponding product at least sometimes.
- Small defects can spread. One aggregation mismatch at a contract packaging site can trigger quarantines at several downstream partners.
- Some corrections must come from the sender. Format and structure errors in an EPCIS file need a correction from the company or provider that sent it.
- HDA provides a shared playbook. Its guidelines define five exception categories and a standard format for reporting them.
- Prevention starts before shipment. Partner testing, certificate monitoring, and advance notice of system changes help stop errors before product ships.
Why EPCIS Data Errors Hold Product at Receiving
EPCIS is the GS1 standard that trading partners use to exchange serialized product data for DSCSA. (Our earlier post covers how EPCIS supports DSCSA compliance.)
Receiving partners check incoming shipments against the EPCIS data the seller sent. When there's a mismatch, or the file can't be processed, the shipment becomes an exception. HDA's exception handling guidelines state that product should not be sold until the exception is resolved. For the manufacturer, that order stays on hold at the customer's dock.
How Often Trading Partners Report Exceptions
In an Informa TechTarget survey of 100 pharmaceutical executives at manufacturers and distributors, conducted in late 2025, respondents reported how often four types of exceptions come up in their inbound deliveries. The percentage who said they encounter each type at least sometimes:
- Data received without the corresponding product: 55%
- Product received with incorrect data: 49%
- Product received with inaccurate aggregation data: 44%
- Product received with missing data: 18%
Exceptions at scale: Large trading networks routinely generate thousands of exceptions per month, and sometimes tens of thousands, according to a May 2026 Pharmaceutical Technology analysis.
Common EPCIS Exceptions Between Trading Partners
The errors behind these exceptions fall into four categories, based on where they enter the data flow.
Timing and Transmission Errors
1. Product Arrives Before Its EPCIS File
The receiving partner can quarantine the product until the data arrives. A file that fails to process has the same effect, so a formatting problem upstream can reach the customer's dock as a missing file.
2. Data Arrives Without the Product
Respondents in the Informa TechTarget survey reported this exception more often than any other. One cause raised at an HDA traceability seminar is product shipped to the wrong customer while the data goes to the right one, as Healthcare Packaging reported.
3. Expired Transmission Certificates
EPCIS files travel over secure connections, such as AS2, that depend on digital certificates. When a certificate expires, transmission can stop without a clear system alert, and the receiving partner first sees the problem as an unexplained quarantine. An expired certificate at an intermediary can disrupt data exchange with several trading partners at once.
Format and Structure Errors
4. Event Times Out of Sequence
Commissioning, packing, and shipping events need timestamps in that order. Files with out-of-order times can fail to process.
5. Syntax, Structure, and Missing Data Elements
GS1 syntax violations, XML structure issues, and missing required data elements can also cause files to fail. These errors stem from files that deviate from the GS1 US implementation guideline for DSCSA. (To read about root causes and mismatches in more detail, head to our post on traceability system integration).
Master Data Errors
6. Missing or Inconsistent Master Data
When a file's product or location data doesn't match the receiver's master data, the file can fail to process. An incorrect location number (GLN) may let the file process but leave the product unable to be picked.
Aggregation Errors
7. Contents Don't Match the Parent Container
Aggregation errors mean the items in a case, or the cases on a pallet, don't match the parent-child relationships in the EPCIS data. They trace back to how cases and pallets are built and scanned on the packaging line. According to the Pharmaceutical Technology analysis, a minor aggregation mismatch at a contract packaging site can spread to multiple downstream customers, including distributors and dispensers, and trigger quarantines at each.
How Trading Partners Resolve DSCSA Exceptions
HDA's exception handling guidelines, rewritten in 2023, cover transactions between manufacturers and distributors and group exceptions into five categories, from data issues to product unavailable for distribution.
Report Each Exception in a Standard Format
HDA's communication guide asks the reporting partner to notify the other as soon as possible and assign a unique issue tracking number. It recommends a standard subject line naming the trading partners, the exception category, and the tracking number.
What Receivers Ask the Sender For
In the Informa TechTarget survey, 98% of respondents had requested new product when they encountered an exception, and 96% had requested new data. Both requests put the next step with the sender.
Assign an Owner to Each Exception Type
The Pharmaceutical Technology analysis finds that the technical defect behind an exception is generally simple. Most of the effort goes into identifying who owns it, aligning stakeholders, and coordinating the correction. The author recommends assigning each exception category to a team, for example:
- Quality for product-level discrepancies
- IT for connectivity, system, and data failures
- Operations for trading partner coordination
How Manufacturers Prevent EPCIS Exceptions Before Product Ships
Preparation is uneven. Forty-five percent of survey respondents weren't adopting new tools or technologies to prepare for exceptions, and 15% weren't doing exception-scenario planning. Several steps on the sending side can catch errors before product ships.
Test With Each Partner Before Going Live
Connectivity tests, a master data exchange, and EPCIS testing in a non-production environment let partners find errors before they affect live shipments.
Deliver Master Data the Way Each Partner Requires
Some receivers want product and location master data inside the EPCIS file, while others take it separately. Confirming each partner's requirement during onboarding helps prevent files from failing on mismatched data.
Build Files to the Guideline Your Partners Use
Format, missing element, and chronology errors stem from deviations from the GS1 US implementation guideline for DSCSA. Building files to the version each partner expects keeps them consistent with what the receiving system accepts. GS1 US is phasing in Release 1.3 of the guideline, with manufacturers scheduled for the first quarter of 2027, and Release 1.2 remains the minimum requirement in the meantime.
Monitor Transmission Certificates
The Pharmaceutical Technology analysis calls certificate failures entirely preventable. It recommends a central inventory of every AS2, SFTP, and HTTPS certificate, with its trading partner, expiry date, and owner; alerts at 90, 60, and 30 days before expiry; and routine connection checks to confirm partners' systems accept renewed certificates.
Coordinate System Changes With CMOs and 3PLs
A configuration change or upgrade at one wholesaler, CMO, or 3PL can affect many connected partners at once. The analysis recommends partner and 3PL agreements that require advance notice, such as 30 days, before any change that could affect EPCIS transmission. For product packaged at several CMOs, standardizing serialization processes and involving each CMO early keeps the data every site sends consistent.
Track Exceptions by Type and Root Cause
The analysis recommends categorizing six months of exception history by root cause, trading partner, and regulatory risk, then focusing on the 20% of exception types that drive 80% of resolution effort. A standardized intake form keeps new exceptions categorized the same way.
EPCIS Data Error FAQs for Pharma Manufacturers
What happens to our product when a distributor flags an EPCIS exception?
Under HDA's guidelines, product should not be sold until the exception is resolved. If the product arrives before its EPCIS file, the distributor may quarantine it until the data comes in.
Who is responsible for fixing an EPCIS data error, us or the distributor?
It depends on the error. A distributor can sometimes resolve an issue internally, such as missing master data. Format and structure errors in the file need a correction from the manufacturer, CMO, or EPCIS provider that sent it.
Can a formatting error in our EPCIS file delay a shipment?
Yes. If the receiving system can't process the file, the product has no usable data and can be held as if the file never arrived.
How do we find the source of repeated EPCIS exceptions?
Categorize exceptions by root cause, trading partner, packaging line, and EPCIS provider. The few exception types that drive most of the resolution effort are the place to start.
How Covectra Helps Manufacturers Reduce EPCIS Exceptions
Covectra provides serialization technology, cloud-based track and trace, and implementation services to pharmaceutical manufacturers and brand owners as a single source.
AuthentiTrack, our EPCIS-certified platform, connects contract manufacturers with brand owners' traceability systems through a secure data gateway. Exception management, issue resolution, and trading partner support are part of the engagement, and Covectra's serialization engineering and integration services cover the line, CMO, and partner connections where exceptions start.
Request a serialization review to find where your EPCIS exceptions originate and what it would take to reduce them.