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Pharmaceutical Pack Management – finding a home

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
www.pinnaculum.co.uk
mark.wilkinson@pinnaculum.co.uk
0044 1438 791111

Pharmaceutical Pack Management - why is it important?

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.

New MHRA Blog goes live

MHRA_website_logo
The MHRA have published their first blog today, focusing on the MHRA Inspectorate and guidance and updates about MHRA inspections.
Here is a link to the site https://mhrainspectorate.blog.gov.uk/

Posted by Mark Wilkinson

Filed in MHRA,

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