Pharmaceutical Labelling: Maintaining Regulatory Compliance

The pharmaceutical industry is one of the most regulated industries in the world. Pharmaceutical labelling must thus follow the strict standards that have been set globally by regulatory bodies such as the FDA, EMA, and WHO. Non-compliances can have serious consequences, from product recalls to huge fines or even reputational damage.

Newman pioneered regulatory compliant pharmaceutical labelling solutions that would enable the manufacturer to manage these demanding requirements without loss of operational efficiency.

The Regulatory Challenges of Pharmaceutical Labelling

1. Adapting to Global Standards

Different countries and regions have different labelling requirements. In some cases, serialisation codes will be required under the EU’s FMD; other examples include the US DSCSA, which requires track-and-trace systems.

The challenge here for a global manufacturer is making sure adaptation to these diverse standards in no way disrupts production.

2. Meeting GMP Requirements

Labels, according to Good Manufacturing Practice, need to remain in place and be readable throughout the product’s life. This requires the labels to be robust and able to withstand environmental stresses, such as temperature and humidity variations.

3. Real-Time Compliance Updates

Regulations change frequently, and many times there is a need to update the manufacturing process right away. Manual changes have a serious tendency to delay production and increase the possibility of error.

Newman’s Regulatory Pharmaceutical Labelling Solutions

1. Automated Compliance Tools

Automatically enabled software updates are installed in Newman’s labelling machines for compliance, both currently and in real-time. This will keep such tools at the forefront of changing regulatory requirements without production downtime.

2. Integrated Vision Systems

Newman’s vision systems go well beyond technical precision; they verify labels against regulatory standards to make sure each product meets the compliance requirements. It includes Optical Character Recognition and barcode scanning for accuracy.

3. Operator Training and Support

Even the most advanced system in the world needs competent operators. Newman provides detailed training to assist teams in staying current with confidence about regulatory changes and limit errors to a minimum for continued compliance.

Ensuring Data Integrity for Regulatory Compliance

Data integrity is at the core of regulatory compliance. Newman’s machines make sure all data, from batch numbers to dates of expiry, are logged in a secure and accurate manner.

1. Real-Time Data Logging

Everything about the production process is recorded, giving a very transparent audit trail. This will enable the manufacturer to meet even the most stringent requirements laid down by regulations such as 21 CFR Part 11.

2. Automated Reporting

Newman’s systems create detailed compliance reports, reducing manual documentation time and effort.

Conclusion

Regulatory controls on pharmaceuticals need systems to be robust to deliver accuracy, flexibility, and compliance. Newman brings new pharmaceutical labelling solutions to regulatory compliance in labelling that enable manufacturers to be one step ahead of moving targets with standards without revealing key operating efficiency. Invest in Newman for more than just a partner who makes it simple to maintain your good reputation; find success in a regulated industry.