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Pharmaceutical Pack Management - why is it important?

Published on 14 July 2015

Pharma Pack Management, artwork administration, artwork co-ordination…..whichever description you use, managing pharmaceutical labelling artwork is a pivotal function in the pharmaceutical supply chain and one that rarely gets the attention it deserves.

Performed effectively, implementing and maintaining compliant labelling for product SKUs (stock keeping units) becomes an opportunity to reduce costs, improve an organisation’s reputation for quality and differentiate them from their competitors.

But perform it badly or not at all, it can harm your patients, kill your company, trigger a product recall, delay product supply or regularly cause stock outs that directly impact the balance sheet. When errors occur, 4 main groups are impacted;

Patients

Effective medical treatment is based on trust at all levels. Patients put their trust in a health professional directly through consultation and prescription. They also place their trust in pharmaceutical companies to produce and supply them a prescribed product to the highest standards of quality and this includes the labelling. An error in the labelling can therefore not only be directly harmful – by causing a prescribing error for instance – but can also undermine the confidence a patient population has in individual drug companies.

Prescribers

There is an expectation held by all prescribers, be they pharmacists, consultants, doctors, nurses or other health care professionals that products and their labelling will be accurate, up to date, free from errors and manufactured to the highest quality standards. Aside from a prescribers trust in a company and product being damaged by labelling errors, they are also directly impacted as remedial action on their part diverts resources away from their primary function of providing health care services.

Regulators

With labelling errors identified as a significant cause of recalls, regulators are increasingly focusing audit attention on labelling change processes. With today’s technological advances providing opportunities for improved quality they are becoming less tolerant of bad practice and have the powers to take punitive action against companies not meeting expected GMP standards.

Pharmaceutical companies

At a macro level, pharmaceutical companies can be significantly harmed, both in terms of reputation and share price, by labelling errors. These indirect costs are joined by the direct costs of managing an incident. Reworking or batch and product write-offs often result, which alone can run into costs of tens of thousands. Drilling down further, the affected artwork studios and process participants will be analysing causes for the error and looking for ways to improve the process.

With its importance better understood our next article will focus on where to locate the pack management department in a pharma business.

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