In highly regulated industries such as pharmaceuticals, food & beverage, and medical devices, accurate product coding is more than just a labeling task—it’s a critical compliance requirement. Poor coding practices, including illegible prints, incorrect batch numbers, or inconsistent barcodes, can create significant regulatory delays, disrupting production schedules and increasing operational costs.

Understanding why coding errors occur and how they impact regulatory timelines is essential for manufacturers seeking to maintain compliance and streamline inspections.

The Importance of Accurate Coding in Compliance

Regulatory bodies require that every product unit has clear, accurate, and traceable markings. These markings typically include:

1、Batch or lot numbers

2、Manufacture and expiration dates

3、Barcodes, QR codes, or serialized identifiers

4、Regulatory labels, including allergen or safety information

Failure to provide this information in a consistent and legible format can result in inspection failures, delayed product approvals, or even product recalls.

How Poor Coding Leads to Regulatory Delays

1. Misprints and Illegibility

Misprints are among the most common causes of regulatory delays:

1）Faded or smudged ink

2）Incorrect print placement

3）Low-resolution or improperly formatted codes

When inspectors cannot read the required information, manual verification or rework is required, delaying approvals.

2. Incorrect Data or Batch Numbers

Coding errors that reflect inaccurate product information can break traceability chains, leading to:

1）Regulatory queries on batch or lot integrity

2）Delays in releasing shipments

3）Potential fines for non-compliance

These issues often arise from manual entry errors, disconnected ERP integration, or improper printer settings.

3. Inconsistent Printing Across Production Lines

Large manufacturing facilities may experience variability between lines, including:

1）Different printers with varying print quality

2）Operator-dependent setup inconsistencies

3）Substrate differences affecting ink adhesion

Such inconsistencies complicate audits and slow down regulatory approvals, as each line must be validated individually.

4. Lack of Audit-Ready Records

Regulators expect complete documentation:

1）Timestamped printing logs

2）Batch verification reports

3）Records of printer maintenance and operator interventions

Without audit-ready records, even correctly printed products may face scrutiny, causing delays in certification or shipment.

Strategies to Prevent Regulatory Delays

Standardize Coding Workflows

1、Implement standard operating procedures (SOPs) for printer setup, ink selection, and line operation
2、Train operators on proper coding procedures
3、Conduct regular reviews to maintain consistent performance

Choose the Right Printing Technology

Different production environments require different coding solutions:

1、TIJ printers for high-resolution codes on small surfaces

2、CIJ printers for high-speed, variable data lines

3、Laser coders for permanent marking on durable packaging

Matching the printer to line speed and substrate ensures reliable, compliant printing.

Integrate Printers with Traceability Systems

1、Connect printers to ERP and MES systems for automated data transfer
2、Validate batch numbers and expiration dates before printing
3、Generate real-time audit logs to meet regulatory standards

Integration minimizes human error and ensures end-to-end traceability.

Monitor Print Quality Continuously

1、Use real-time print monitoring to detect smudges, faded prints, or missing codes
2、Schedule preventive maintenance to reduce downtime
3、Replace worn printheads promptly

Continuous monitoring ensures consistent compliance across all products.

Benefits of Proper Coding Practices

Manufacturers who address coding challenges can achieve:

1、Faster regulatory approvals with inspection-ready products

2、Reduced recall and rework costs

3、Improved operational efficiency

4、Enhanced traceability and product integrity

Ultimately, accurate coding protects both compliance and brand reputation.

Coding Accuracy Is a Regulatory Imperative

Poor coding is not just a technical issue—it has direct regulatory consequences. Misprints, incorrect batch data, inconsistent practices, and missing documentation all contribute to inspection delays and compliance risks. By standardizing workflows, selecting appropriate printing technologies, integrating systems, and monitoring print quality, manufacturers can prevent delays, maintain traceability, and ensure smooth regulatory approvals.

Prevent Regulatory Delays Today

If your production lines face inspection delays or coding inconsistencies, contact our company to:

1、Audit your coding systems for compliance risks

2、Integrate printers with ERP, MES, and traceability platforms

3、Standardize workflows and train operators for accuracy

4、Implement real-time monitoring to prevent errors

Let us help you ensure coding accuracy, streamline approvals, and maintain regulatory compliance.