Pharmaceutical products play a crucial role in modern healthcare, as they are designed to diagnose, treat, and prevent a wide range of illnesses and conditions. These products are subject to strict regulations and guidelines to ensure their safety and efficacy. One crucial aspect of this is accurate labeling, which is essential for ensuring that patients receive the correct medication in the right dose and at the right time.
Pharmaceutical Products and the Importance of Accurate Labeling:
Accurate labeling is a critical component of the pharmaceutical supply chain, as it helps to prevent medication errors, adverse reactions, and other safety issues. For example, a medication that is labeled incorrectly could result in patients receiving the wrong dose, which could lead to adverse effects or even death. In addition, a medication that is not properly labeled may not be stored or administered correctly, which could also lead to safety concerns.
The Critical Role of Accurate Labeling in the Pharmaceutical Supply Chain
The importance of accurate labeling is particularly evident in cases where medications have similar names or packaging, which can make it difficult to distinguish between them. For example, in 2006, the Institute for Safe Medication Practices (ISMP) published a report on a medication error involving two drugs, Serzone and Seroquel. The drugs had similar names, and as a result, a patient received the wrong medication, which led to severe adverse reactions.
The Impact of Similar Names and Packaging on Medication Safety
In response to incidents like this, regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have developed guidelines and standards for pharmaceutical labeling. These guidelines cover various aspects of labeling, including product name, dosage form, strength, route of administration, and storage conditions. They also require manufacturers to include information on potential adverse effects and other safety concerns, as well as instructions for use and handling.
Regulatory Guidelines for Pharmaceutical Labeling
The CTE350 is a fully automatic tamper-evident labeler that can process up to 350 cartons a minute and accurately prints onto small cartons. The machine’s compact size of just over 1m in length enables easy integration into existing packaging lines.
With a GMP design, the CTE350 separates cartons and transports them past two stepper motor-driven stations. Labels are applied with a roller for neat and even attachment.
Newman’s Label Application Machines
Newman’s automatic tamper-evident labelers allow customers to meet international pharmaceutical packaging regulations such as The Falsified Medicines Directive (FMD) 2011 / 62 / EU, which will come into force by February 2019. The firm’s machines help meet this new directive with the inclusion of tamper-evident features and unique carton identifiers.
Newman’s label application machines are flexible, reliable, and safe, and can swap between different types of labels without changing parts. The company also offers self-adhesive, tamper-evident, anti-counterfeiting, and hologram labels that can be adapted to a wide range of carton sizes.
Specifically designed for healthcare applications, the CTE350 and CTE450 have a stainless-steel / good manufacturing practice (GMP) construction and are available with a full validation documentation package.
In addition, Newman is able to integrate different print and inspection systems to meet a customer’s specifications.
