Pharmaceutical Pack Management – finding a home

Published on 22 July 2015

As discussed in our previous article, Pack Management is a critical function that touches multiple stakeholders and departments. Regulatory Affairs, Supply Chain, Production, QC and QA are all significant process stakeholders, but Medical, Legal, Commercial and other departments may be contributors or have pack management dependencies in their own processes too. With pack management impacting so many disciplines, internally resolving ownership of the function can often be challenging but it is a decision that if well-made can reap significant benefits.

It must appear tempting, particularly for smaller companies, to consider moving responsibility for product pack management and labelling artwork almost entirely to the manufacturing site, whether they be ‘in-house’ or contracted. This approach can indeed be attractive and may be perceived as effective for the first product launch or when only one or two manufacturing sites support a company’s product portfolio.

However with expansion comes complexity and additional management challenges. The quick fix of moving responsibility to the CMO may no longer feel so wise. You may now have the need to manage multiple labelling change controls across two or more suppliers, who likely have different approaches or processes. Grasping the nettle and having a single function – internal or outsourced – working to a consistent process and responsible directly to and liaising with all process stakeholders, can provide significant advantage in terms of demonstrable control, efficiency and cost. But in which functional group does it find the best fit? Here’s a summary of the favourite options;

Regulatory Affairs – a common home for pack management and the origination point for the SmPC, registered text and all non-technical content that appears on a component artwork. Regulatory Affairs are also the source for change implementation constraints, being the main conduit between the company and the regulatory authorities. However as a medical department, interaction with supply chain and manufacturing functions is less common, as is exposure to the daily rigours of GMP.

Quality – fundamentally, the role of ensuring that a product is manufactured in compliance with regulatory requirements and according to Good Manufacturing Practice (GMP) standards falls to the Quality function in a pharmaceutical company. As it is a cross-functional department with close interaction with Regulatory Affairs, Supply Chain and the production sites, the case can be made that the Quality Assurance department is the ideal candidate to deliver the pack management role. However, one of the main responsibilities of the QA department is to remain an independent reviewer and approver with respect to manufacturing and process/ product development units. It could therefore be seen as a conflict of interest between their regulatory responsibilities and their actual daily activities.

Production – With a primary responsibility for manufacturing product that is fit for purpose, the production facility often provides a home for pack management. When sitting within the manufacturing site, pack management departments are close to the eventual point of need, well aware of the demands and lead-times of the facility. For companies with small product portfolios manufactured at one facility, locating packaging artwork change control activities within an environment already versed in GMP can be extremely effective. For large multinationals too, with networks of facilities across the globe, an integrated international pack management organisation located at a network of production sites can provide a service that never sleeps. But manufacturing site priorities may have a different focus to regulatory affairs and other stakeholders and balancing these contrasting needs can be challenging.

Supply Chain – For many, supply chain appears the optimal pack management process owner. The supply chain team is intrinsically responsible for ensuring product is manufactured, released and delivered on time and to the right place. Artwork for packaging labelling therefore can be seen as another element of the production process and Bill of Materials to be managed. And with technical elements of information being sourced from technical operations partners and suppliers, key relationships are most easily established from this process location. However, with supply chains measured on stock availability and cost and a skillset focused on logistics and product delivery, the detailed nuances of artwork creation and pack management can be easily overlooked or not given the profile they warrant.

As can be seen, there are pros and cons for all of these potential homes for Pack Management. What does become clear is that the pack management function provides the glue that bonds several disparate departments together and requires cross-functional leadership, administration, technical knowledge and team-work to deliver compliant artwork, on-time, every time and without error. How it does that will be the subject of a later blog post.

Pinnaculum are specialists in pharmaceutical pack management services; outsourced administration, artwork creation, technology and optimised process design. If you would like to know more of how we help companies deliver world class pack management that makes a difference to their reputation and balance sheet, visit our website or give our offices a call.

Mark Wilkinson
Pinnaculum Ltd
0044 1438 791111

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