Manufacturing and Production

Pharmaceutical Packaging, Labelling and Serialisation

A mislabelled medicine is a recall at best and a patient harm at worst, and packaging lines are where a batch that has been controlled through manufacture meets the highest volume of manual and mechanical handling it will ever see. This course covers protecting it there. Delegates work through primary packaging materials and the barrier and compatibility requirements each product carries, including blister, bottle and vial systems. Container closure integrity is addressed. Line clearance is treated as the critical control it is, since almost every mix up traces to an incomplete clearance. Coding, printing and verification systems follow, including vision inspection and reject handling. Labelling content, artwork control and version management are covered, since an obsolete artwork in circulation is a recall waiting to happen. Serialisation and traceability requirements are addressed, including aggregation. Line efficiency and changeover are covered. The course closes on packaging batch records, on reconciliation of printed components and on recall readiness.