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Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.
As concerns about drug product safety have increased, national governments worldwide have been setting deadlines for implementing traceability and tracking of pharmaceutical products. Requirements vary, with many countries requiring a GS-2-compliant solution and 2-D barcoding. The US deadline is now just a little more than two years away. Yet, consultants say not all pharmaceutical companies are prepared.
At a time when more of them are outsourcing key functions in manufacturing and packaging, many pharmaceutical manufacturers are not involving their contract development and manufacturing partners (CDMOs/CMOs) in planning and implementation. Some consultants have guessed that manufacturers may be counting on the deadline for serialization to be postponed, because the last time a major serialization deadline was set, by the California Board of Pharmacies, it wound up being pushed back three times.
Assuming that the 2017 deadline is elastic would be a serious mistake, consultants warn. Developing a workable strategy will require top-down support from senior management, buy-in from operators and the ground floor, and a cross-functional approach.
Especially important are the program charter, the establishment of a steering committee involving all disciplines that will be affected by serialization changes, and strong user requirement specifications (URS) with technology vendors, according to Steve Peterson, project manager with CRB Consulting Engineers. Peterson, who has worked on serialization projects with pharma companies of all sizes, shared advice and best practices with Pharmaceutical Technology.
Serialization issuesPharmTech: What are the biggest issues that sponsors and CMOs need to keep in mind when working on serialization through the lifecycle of this type of project?
Peterson: The biggest issue that we see right now is one of, I wouldn’t call it nonchalance, but inactivity. If any manufacturers or CMOs have not started the gap assessment process, then they are way behind. This process requires studying the equipment and infrastructure they have now, and the processes in place, how well they work, and comparing each of them to where they will need to be, not only for the 2017 but the 2023 requirement.
As the deadline approaches, available resources will become extremely scarce, both from consultants, vendors, and even within their own companies. Equipment deliveries are up, stretching out for the next six months, and we’re not even into the heat of the installation and procurement period yet.
There is too much focus on November 2017, in isolation. In reality, one needs to back that date up by six months, give or take, to take Murphy’s Law into account, because things never go exactly as planned. We’re more than halfway through 2015, so there are only 24 months left, realistically. Every bit of that time will be taken up by IT infrastructure, equipment purchasing, design, validation, and startup.
Strategies for serialization compliancePharmTech: So how do you develop a strategy? What do pharmaceutical sponsors need to do, and how should CMOs work on their own strategies, since they have so many customers in different therapeutic areas and parts of the world?
Peterson: The first thing that any owner company needs to do is to understand the work streams within its own operations, to get down to the SKU level and to understand where each of those products go and where the data come from. They also need a thorough understanding of the types of equipment that are online, what type of print technology is being used.
Serialization offers an opportunity for people to look at their operations and processes, and ask what else they can do to offset the efficiency losses that will result from changes to the lines for serialization. The same applies for CMOs. They have the additional challenge of needing to maximize flexibility, because they are going to be receiving data and different requirements from different owners. Understanding their processes comes first, so that, when owners come to them with their different requirements, they can communicate clearly.
PharmTech: At the INTERPHEX conference in New York City last spring, you told the story of a six-month pilot project taking 18 months. Is that time frame typical? What are the typical reasons for time, scope, and cost creep?
Peterson: I would love to say that there is a perfect project management process, but there isn’t. Because these types of projects are so new and so extensive, initially many people have a mindset of ‘all you have to do is put a code on a bottle.’ Then they miss things.
Yes, at the end of the process, one must put a code on a bottle, but there is a need to take a step back and consider the much bigger picture. Where are those numbers coming from? From another software package? Where does that software reside, onsite or in the cloud? What types of IT systems does the company have, and what types of backup and recovery systems?
It is also important to consider potential changes when you are dealing with vendors and setting up user requirement specifications (URS). The other thing that most companies don’t take into consideration is the impact that work on serialization will have across the entire organization.
With a typical packaging line, you inspect the equipment, procure it, install it, and start it up. For this type of project, you are going to have an impact on regulatory and legal departments, and on your labeling systems. You may be changing artwork on your unit labels. You may be changing labels on cases and even pallets. You’re changing standard operating procedures (SOPs) for your operations, and changing the fundamental operating line.
Questions come up such as, ‘When can they take bottles off the line?’ or ‘How does quality control take a case out of the pallet to run tests on it? When do you release pallets?’
It’s all-encompassing, not just a simple coding project out on the manufacturing plant floor. Success comes back to understanding your systems now and what you need to do, whether that means adding fields in master data for exemptions or determining why you are, or aren’t, coding. It’s much bigger than most people start out thinking.
PharmTech: How do you ensure cross-functional input?
Peterson: You need to have buy-in from senior management, and their commitment to having a steering committee for the project that represents all the key functional departments within the organization--not just engineering, but regulatory, legal, operations, and manufacturing, CMOs. They all must be represented there.
PharmTech: How do you engage people on the plant floor?
Peterson: The sooner you do this, the better. If you do not engage them, if you don’t ask for their reality check on your plans and ideas, you will see a real, negative impact on your line efficiency.
The most important thing to communicate to them is the reason why serialization is being undertaken in the first place. Once they understand that the project will help preserve the integrity of medicines and the supply chain, they are usually very supportive. They’ve also told us that ideas we thought were great, weren’t. ‘Why don’t you do it that way, instead?’ It’s important to listen to them.
PharmTech: These projects are costly. How do you discuss return on investment (ROI), if you need additional senior management support?
Peterson: Some people understand numbers, others need key performance indicators, but the lifeblood of any company is being able to distribute and sell its products. If they’re not ready in time, they won’t be able to ship products. Executives cannot afford to see serialization as just an engineering issue, but a total company issue.
ROI is difficult to quantify, and with any serialization program, you are going to take a hit, economically. But efforts highlight areas for improvement. For instance, as a result of serialization work, one company replaced two slower and less efficient lines with one brand new line. Is that due specifically to serialization? Maybe not, but by looking at their strategic long-term plan, they were able to see opportunities to improve efficiencies.
Article DetailsPharmaceutical Technology Outsourcing Resources Supplement
Vol. 39, No. 17
Citation: When referring to this article, please cite it as A. Shanley, " Serialization: Are You Prepared? Why this time is different," Pharmaceutical Technology Outsourcing Resources Supplement 39 (17) 2015.