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.
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.
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:
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.
The errors behind these exceptions fall into four categories, based on where they enter the data flow.
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.
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.
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.
Commissioning, packing, and shipping events need timestamps in that order. Files with out-of-order times can fail to process.
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).
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 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.
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.
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.
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.
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:
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.
Connectivity tests, a master data exchange, and EPCIS testing in a non-production environment let partners find errors before they affect live shipments.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.