The impact of serialisation on operational efficiency and productivity in pharmaceutical sites: A literature review

Abstract

Serialization technology was introduced to protect the pharmaceutical supply chain from falsified and substandard medicines infiltration. The implementation of serialization systems required a substantial investment by pharmaceutical manufacturers. This study investigated the impact of Serialisation on operational efficiency and productivity in the pharmaceutical industry. A literature review demonstrated limited publications on Serialisation concerning its costs and effects on packing line operational efficiency and productivity. Therefore, a literature review was carried out to assess the relationship between Serialisation, operational efficiency, and productivity. The study revealed that Serialisation had the potential to impact pack line Operational Equipment Effectiveness negatively and line availability, as well as the unit cost of packaged pharmaceuticals and that actual capital costs of Serialisation were greater than the costs originally outlined by policymakers. In addition, the study identified a trend where pharmaceutical sites move away from smaller batch production and toward larger batches to gain greater efficiencies. This is the first study of Serialisation literature from a manufacturing viewpoint.

Keywords:

• pharmaceutical cost of goods sold
• pharmaceutical COGS
• pharmaceutical OEE
• serialisation OEE

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This research received no specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Notes on contributors

Daniel O’ Mahony

Dan O'Mahony, MSc is a part time PHD student in the College of Science & Engineering in the University of Galway under the supervision of Dr. Olivia McDermott. Dan also lectures part time on the Irish National Institute for Bioprocessing Research and Training/Atlantic Technological University Sligo's joint program in Bio-Industry 4.0.

Olivia McDermott

Dr Olivia McDermott is an Associate Professor in Operational Excellence and Regulatory Affairs in the University of Galway, Ireland. She has co-authored over 90 peer reviewed research papers and conference papers. She has eight PHD students within her Operational Excellence Research group working on Medtech Regulations, Risk Management, Lean and Quality Management.

Alan Lynch

Dr. Alan Lynch is currently the Head of Professional Education at Grant Thornton Ireland and was Head of Faculty of the Graduate Business School at Griffith College, Ireland where he continues to lecture part time.

Kathryn Cormican

Dr. Kathryn Cormican is a Professor in Systems Engineering at the University of Galway. She leads research in the areas of in the area of Technology Innovation Management and Enterprise Systems in the School of Engineering. Her research group Enterprise Research Centre comprises nine PhD students, two research associates and two postdoctoral fellows.