pharmaceuticals

Labels for Pharmaceuticals

 

 

The printing of labels for the pharmaceutical industry, including food additives and vitamins, is one of Pitkit’s special areas of expertise. Industry standards such as the FDA regulation 21 CFR and the European Directive 2001/83/EC mandate legibility, clarity and print quality to improve the dissemination of the right information to medical professionals and patients. Non-compliance can be costly for the manufacturer and Pitkit’s extensive experience and knowledge in the area will reduce the risk of such occurrences.

Printing Accuracy

High printing accuracy means zero print errors, no variations in print size or font weight and identical results from one batch to another. A computerized quality assurance system scans every label to confirm adherence to accuracy and doesn’t have to rely on the human eye to identify rejects. This proves more cost effective than human-only QA procedures by avoiding batches of packaging being rejected later on, at a high cost to the manufacturer.

Pitkit incorporates industry best practices in drug label production and so ensures top label quality and compliance with regulatory standards. This is achieved through a controlled process that involves interaction and approval from the customer’s QA teams at all phases of production.

Certification of Pharmaceutical Labels

The main stages of QA certification are listed below:

  • A visit to the Pitkit production facilities by the pharmaceutical manufacturers’ QA team where our state of the art label printing machinery is examined and approved.
  • The customer gives detailed QA procedures that need to be performed on the printed labels and forms that need to be completed and reported back to the customer for review.
  • Pre-production samples are produced and scrutinously examined; any flaws found are corrected. The final approved version is saved as a master pattern into a computerized AVT system of production control that ensures every single label printed is an exact likeness of the blueprint.
  • The drug manufacturer’s QA representatives are often present during the label printing process to oversee the accuracy of the labels.
  • On the basis of the above and of Pitkit’s commitment to the manufacturer’s procedures, the drug company certifies Pitkit as an approved packaging and label supplier for their products.

 

Serialization and Anti-Fraud Mechanisms

There are two further considerations the pharmaceutical, food additive and vitamin manufacturers are acutely aware of:

  1. The danger of fraud.
  2. The benefits of serialization – variable information merged from a database and printed serially from one label to the next as they roll off the digital printing press.

 

These issues are labeling solutions in themselves and combine with drug labels and other disciplines to maximize the contribution of the label and packaging to the product’s objectives.
See Variable Data Labels for more information.



For more information about drug labels and labels for associated areas such as vitamins and food additives, contact us without delay.