Avoiding non-Compliance in Packaging Operations
Im Auftrag der ECA Academy

Packaging of medicinal products, blistering as well as cartoning for example, plays a crucial role in the quality and safety of a medicine. Deficiencies of primary packaging may alter the efficacy or stability of a product; failures in secondary packaging may do harm to patients even worse when products or the folding boxes are mixed up. Therefore, packaging is defined as (the last) pharmaceutical manufacturing step and one of the most critical ones. It is not surprising that the biggest part of recalls is caused by failures during packaging. The FDA reported that more than 30% of recalls of tablet products during the last 5 years were caused by label mix-ups, incorrect packaging or incorrect products insert. On the other hand, despite the high criticality of the packaging process, the packaging plants are required to cut the costs and raise their Efficiency.

Another challenge for the packaging units is the new EU Directive, requiring safety features and authentication measures in order to raise the hurdle for drug counterfeiters. As a consequence of the “COMMISSION DELEGATED REGULATION (EU) 2016/161”, the rules apply from 9th of February 2019 onwards except for some member states with an existing Verification System. Packaging lines have to be equipped with systems for printing and reading two dimensional codes (2D-Codes) and these systems have to be linked to the materials management system. Companies already shipping serialized products have been reporting from technical hurdles which should not be underestimated. Most companies without experience in this field will need external help. But technical expertise could become rare in the near future.

There are numerous requirements which have to be fulfilled in the packaging plant. During this GMP course we will focus on: