Guest Column | March 2, 2018

5 Keys To Successfully Navigate Pharmaceutical Packaging Development

By Michael Esposito, TrainReach Consulting

5 Keys To Successfully Navigate Pharmaceutical Packaging Development

A pharmaceutical package is created by an amalgam of the talents of packaging engineers, labeling project administrators, proofreaders, graphic artists, and managers. These players approach their tasks using very different mind-sets, but their collective efforts enable companies to complete their packages on time to provide quality products to consumers. The process is intuitive, and while the steps are laid out in a typical set of SOPs, there is a glue that brings the various units together. Most employees working in these areas achieve success by utilizing these unstated skills, but breaking them down and stating how they work in unison — using them consciously instead of unconsciously — will enable you to be even more successful.

The Primary Participants In Packaging Creation

The packaging department is normally involved in the conceptual design of a package in the early stages, well before the labeling department’s activities begin. The packaging engineer’s education encourages them to approach their subject from a scientific perspective and deadlines, while important, are secondary to the resolution of technical challenges. The engineers are dependent on hard data to answer typical questions such as package and product stability, torque, the ability of a given packaging component (e.g., label, box, carton) to run successfully on the company’s machinery, how to test components for strength and avoidance of breakage, and how to list the components with the proper order and instructions on the bill of materials. It is not rare to find them uncomfortable with the “soft skills” that accompany human resources activities or the intuition that marketing relies on to achieve success in their objectives.

The labeling project administrator, similar to a project manager, is deadline-driven, as it is their responsibility to ensure the labeling artwork reaches the printer in time to satisfy production orders. They interpret the instructions provided by regulatory affairs, packaging, and other stakeholders and make them ready for printers and manufacturing facilities. They are usually the most affected by delays in availability of the approved text or by changes in the project in the middle of the labeling creation process. Their communication skills have to be optimal, as their job requires many interactions and inputs. There is very little time for them to view their work from a global perspective because of the volume of artwork they handle and the multiple deadlines they face.

A proofreader often comes from a liberal arts background and has a strong command of written English. Many of them came to the pharmaceutical industry from publishing. Their success is obtained by finding minute errors that could have disastrous consequences if allowed to pass through to the printing and production phases. For them there is a constant tug-of-war between the need to be accurate and the need to adhere to a schedule, and they are most successful when kept out of the fray of the typical day-to-day. They may even have offices separate from the rest of the employees in their department.

The graphic artist on the production side may feel the artwork they work on does not utilize their creativity. There is more creativity on the sales and marketing side, and the necessities of production appear to stifle creativity. They are there most likely because of job stability. While many are attentive to detail, their primary focus is not to proofread but to fit all the text, code, and color elements into the designated space, using the drawings the packaging engineer has designed. When there is an opportunity to exercise their creativity, they usually rise to the challenge and deliver beyond expectations.

Management has a common set of needs and expectations, but in the area of packaging and labeling, most of them, in my experience, started as packaging engineers or in some aspect of the supply chains. You will rarely find an individual assume responsibility in this area without working a healthy part of their career in packaging, except at a very high level. As a consequence, they may still wish to pay attention to the smaller details and their people skills may not get the attention they require.

Tips For Getting Everyone On The Same Page

How can you, as a manager or individual contributor in the packaging and labeling environment, take advantage of the strengths of each type of employee?

1. Tailor your communication to your audience's needs.

While this is a truism, it can be particularly helpful when communicating your needs to each constituency. For example, if you are called to present to a group consisting of most of these employees, add elements you know will appeal to each group. Add real-life examples and call on your employees to confirm and elaborate on them. I did this often in my training sessions, knowing there would be packaging engineers, graphic artists, project administrators, proofreaders, and equipment engineers in attendance. Most individuals want to share their knowledge, and giving them that opportunity keeps their interest.

2. Resolve disputes keeping each group’s preferences in mind.

It is inevitable that each group will complain at times about the inputs they receive from other constituencies, especially when tight deadlines are commonplace. Address the issues, speaking to each group’s training, and seek compromise when possible. However, don’t be afraid to be firm if a particular group is uncooperative or not taking ownership of an area that is clearly their responsibility. Sometimes this reluctance is due to fear of change, especially when a large one is looming, and a little reassurance can go a long way. One of my responsibilities in packaging was to deliver training for a new document management system which, on its surface, was quite intimidating. However, there were clear equivalents to our legacy system and I found opportunities to communicate these commonalities during training.

3. If you are a manager, assign projects to employees keeping their strengths in mind.

The majority of an employee’s responsibilities may fall within the realm of routine activity, but that doesn’t mean you can’t add a project that taps into their unique skill set. In a job that focused on pharmaceutical training in the packaging group, I was assigned a project on sustainable packaging, which provided both a benefit to the company and an opportunity for me to learn more about my field.

4. Act as an advocate to streamline workflow processes where possible.

You can do this regardless of your role. A common issue in packaging and labeling is an unnecessarily complicated number of handoffs for a packaging or artwork project. You may not have control over processes outside of your area or the lack of available information for you to move forward on your part of a project, but plenty can be managed in your immediate realm. Examine the proofreading process, and make suggestions to maintain a balance between quality and reduced cycle time. Look at bills of material and packaging specifications for common text that can be standardized and added to your document management system as a dropdown instead of a free text field.

5. Finally, a general suggestion: Pay attention to things that bother you.

We often don’t realize our actions are reflections of other events in the periphery that often have nothing to do with the issue we are dealing with or the individuals with whom we’re interacting. In one of the companies I worked with, there was great emphasis on using mindfulness techniques to manage our stress levels and maintain our perspective, especially when planned activities went awry. There are plenty of unanticipated events in packaging and labeling, especially because the bulk of our activities exists shortly before the implementation of a product launch or revisions to existing product. Composure in the face of outside events is key.

About The Author:

Michael Esposito, principal at TrainReach Consulting, LLC, has over 30 years of experience in the pharmaceutical industry and 17 in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas, including packaging, project administration, quality assurance, government contracts, translations, systems training, and international operations. He collaborated on the development and implementation of the training portion of the consent decree work plan for McNeil and revised its introductory GMP course. Esposito is a member of the training organizations GMP TEA and the Association for GxP Excellence (AGXPE). His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging. You can reach him at