Why Track Assets Across GMP Manufacturing Environments?

Crebhan Hughes
Intelligent Asset Mapping White Paper - Asset Management

Abstract

Pharmaceutical facilities routinely lose productivity and risk compliance lapses because critical mobile assets—from portable vessels and calibration standards to single-use kits—move through highly regulated spaces with little real-time visibility. Industry surveys show technicians squander three to eight hours per week searching for equipment, while deviations triggered by missing or out-of-calibration items can cost hundreds of thousands of euros annually. Learn how real-time location systems (RTLS) and related technologies helps to eliminate eliminates search time, shortens changeovers, improves asset utilisation and strengthens data integrity. Outlining the criteria for selecting assets to tag, assesses when a facility needs an RTLS, comparing technology options against GMP constraints, and highlighting implementation best practices. Case studies cite up to €1.1 million yearly gains and 50% drops in compliance deviations, positioning mobile asset tracking as a pragmatic cornerstone of digital transformation and operational excellence in modern pharma manufacturing.

1. Introduction

In pharmaceutical manufacturing, critical assets like production equipment, calibration standards, and even materials are constantly on the move – transferring between cleanrooms, storage, labs, and production areas. Keeping track of these mobile assets is not just a logistical concern; it directly impacts operational efficiency, compliance, and data integrity. Yet many pharmaceutical facilities still rely on manual logs or ad-hoc searches when an asset is needed, leading to wasted time and often production delays. In fact, industry surveys have shown that technicians can spend between 3 and 8 hours per week simply searching for equipment linkedin.com. This hidden inefficiency saps productivity and can contribute to production delays, missed maintenance or calibration schedules, and data integrity issues.

As outlined by Sandeep Bhutani and Mayuresh Kulkarni in a previous IPSE iSpeak article “Location tracking is very critical in day-to-day operations in pharma/bio-pharma manufacturing as it directly impacts the plant efficiency, material wastage, streamlining of operations, asset usage and regulatory compliance" ispe.org. When equipment or materials cannot be located in a timely manner, operators may pause processes, or even re-order items, leading to waste. Important tasks like calibrations or cleaning can be delayed if the item isn’t where it’s expected. And in the worst case, an unlocated asset might cause a batch deviation (for example, if a required calibrated instrument isn’t available, or if a vessel exceeds its allowable clean hold time because it was forgotten in a corner). Over time, common patterns of inefficiency and compliance risk emerge across different sites – even though each facility has unique layouts and processes, the fundamental issue of not having real-time visibility of assets is pervasive.

Mobile asset tracking solutions have therefore become an important tool in modern pharma manufacturing to address these challenges. By deploying technologies that provide real-time or on-demand visibility of asset locations, companies can streamline operations and reduce compliance risks. This article explores how a range of tracking technologies (RTLS, Wi-Fi triangulation, RFID, BLE, mesh IoT beacons, etc.) can be applied to pharmaceutical environments, the types of assets that benefit, and key considerations in implementing a tracking system.

2. Challenges in Managing Mobile Assets

Pharmaceutical plants are typically large, complex environments adhering to with strict regulations. Within these facilities, mobile assets refer to any physical items that move around and are not fixed in place. This includes a wide range of portable production equipment, calibration standards, containers, tools, and materials or components. Some common challenges associated with managing these mobile assets are:

These challenges are common across all types of pharmaceutical manufacturing sites. In our experience working with different plants, each facility initially believed their situation was unique – one site struggled mostly with calibration instruments being misplaced, another with production totes, another with assets on a lifting register. Yet all shared a core problem: lack of real-time asset visibility. Addressing this problem has a broad impact: when people spend less time searching or worrying, they can focus more on productive work, and the operation as a whole runs more smoothly and safely.

3. Which Assets Should You Track?

Not every item in a facility needs an electronic tracker on it. Deciding what to track usually comes down to a combination of impact on operations, risk, and value of the asset. Below are some categories of assets in pharmaceutical manufacturing that often justify tracking, along with why they matter:

When deciding which assets to tag, it’s wise to start with those that cause the most pain when missing or misplaced. Engage with different departments: Production might highlight vessels and filters; Maintenance might point to calibration kits; QA/Compliance might emphasize instruments and safety gear. Each site will have a slightly different priority list, but generally the categories above are a good starting point for most pharmaceutical manufacturers. Remember, the goal is not to track everything that moves – it’s to track what matters enough that real-time visibility will improve efficiency or compliance in a tangible way.

4. Assessing the Need - Do You Need an RTLS?

Before diving into technology, a facility should assess whether a formal asset tracking system is justified. Some guiding questions to consider:

If the answers to several of these questions point to issues, then it’s likely time to evaluate an asset tracking solution. It can also be helpful to estimate the potential ROI: consider time saved, avoided production losses, avoided capital spend on duplicates, and reduced compliance risk (which is harder to quantify but extremely important). In one real-world example, a pharma site experiencing frequent production interruptions implemented a tracking system and documented almost €1.1 million per year in combined savings and extra production output due to the improvements. This kind of analysis helps build a business case for management.

It’s worth noting that many leading pharmaceutical manufacturers have already begun adopting such solutions. According to ISPE’s publications, most pharmaceutical companies are at least evaluating RTLS (Real-Time Location Systems) in their plants, and the frontrunners have started implementing them as part of their operational excellence and digitalisation programs ispe.org. If your facility is lagging behind in this area, there’s a risk of falling behind industry best practices – but conversely, that means there are plenty of case studies and lessons learned out there to draw on.

5. Tracking Technologies: Options for Pharma & GMP Environments

Once the decision is made to improve asset tracking, the next question is how to do it. There is a broad range of technologies available, each with its strengths and limitations. The choice isn’t one-size-fits-all; it depends on factors like required accuracy, existing infrastructure, budget, and environmental constraints. Here we outline the main categories of tracking technologies that I have seen deployed within pharmaceutical environments:

6. Key Considerations for Selecting a Tracking Solution

Implementing mobile asset tracking in a GMP (Good Manufacturing Practice) environment isn’t as simple as sticking tags on everything. It requires careful planning to ensure the solution truly meets the site’s needs and complies with regulatory expectations. Based on experience and industry best practices, here are key factors and considerations when evaluating and selecting a solution:

7. Operational and Compliance Benefits: What to Expect

When mobile asset tracking is successfully deployed, the benefits span multiple dimensions of operations. Based on case studies and real deployments in pharmaceutical manufacturing, here are some of the key improvements that can be realized:

To illustrate the impact, consider the earlier example site that saw nearly €1.1M/year benefit – it wasn’t one single improvement, but a combination: shorter waits and changeovers (yielding more batches), fewer investigations or non-value activities, and avoided costs (not buying extra gear, not losing product to deviations). Another facility focusing on IBC management recorded a 50% drop in instances of exceeded clean hold times, eliminating up to four GMP deviation investigations per year. Each investigation can cost tens of thousands of euros in labor and potential production impact, so this was a notable compliance and cost avoidance win.

These results underscore that mobile asset tracking is not just a “nice to have” gadget, but a practical solution to long-standing problems. It directly attacks several of the “lean wastes”: it cuts down search times, waiting, and overuse or inventory. It also enhances the “sixth M” (Materials, Method, Machine, Man, Measurement, Mother nature – some add a sixth: Information) by ensuring that the information of where things are is readily available, thus strengthening the overall manufacturing system.

8. Conclusion: Embracing Mobile Asset Tracking for Modern Pharma Operations

Pharmaceutical manufacturing is evolving with Industry 4.0 and digital transformation initiatives, and mobile asset tracking is increasingly recognized as a key component of this. In an era where every minute and every piece of equipment in a plant counts, having immediate knowledge of asset locations and statuses is becoming essential for operational excellence. No longer seen as just an experimental tech, these tracking solutions have proven their value in real facilities – from small improvements like a technician saving 10 minutes, to big wins like enabling additional batches and preventing compliance issues.

From the perspective of a professional who has worked with multiple pharma manufacturers, one clear observation emerges: each site has unique processes and constraints, but all can reap benefits from improved asset visibility. Whether it’s a biotech campus struggling with tracking single-use components or a brownfield pharmaceutical plant trying to keep up with calibration tools and audits of a lifting register, the introduction of a tailored tracking system tends to reveal latent efficiency gains and risk reductions.

When considering implementing such a system, pharma companies should remember that success lies in cross-department collaboration and aligning the solution with broader business goals. If done right, a tracking system doesn’t just locate assets – it can become a platform that interfaces with ERP, MES, maintenance, and even quality systems, supporting a more connected and smart factory floor. As noted in an ISPE discussion on RTLS, identifying the key issues and evaluating the fit of RTLS components with a clear eye on ROI is crucial ispe.org. In other words, know your pain points and measure what matters.

Looking ahead, we can anticipate that mobile asset tracking will become as common in pharma plants. The technology costs are coming down, accuracy and ease-of-use are improving, and the value is evident. Those who have adopted it are already seeing smoother operations and stronger compliance postures. Those who haven’t yet might soon find themselves persuaded by a pressing internal need for better handling of asset management.

In conclusion, investing in a robust, well-thought-out mobile asset tracking strategy is investing in the operational resilience and efficiency of a pharmaceutical facility. It addresses practical challenges of today – saving time, reducing errors, improving utilisation – while also laying groundwork for the data-driven, agile manufacturing of tomorrow. In the competitive and highly regulated pharma industry, that combination of efficiency and compliance assurance is a powerful advantage, helping to deliver medicines to patients faster and with greater confidence in quality.