Increasing quality in pharmaceutical manufacturing isn’t just good for business profits—it’s an ethical mandate. Patients place their health in the hands of the scientists, laboratory staff and supply-chain specialists involved in pharmaceutical manufacturing and distribution. Here are some ways to increase quality in pharmaceutical manufacturing.

1. Safeguard machine health and uptime

Pharmaceutical manufacturing and distribution companies wishing to increase quality can start with their production assets. When critical equipment goes offline because it’s been run to failure or its performance slowly degrades because a component is wearing down, product quality and profits suffer. Here are some avenues companies can take:

• Invest in long-lasting equipment. Ensuring minimal maintenance requirements and machine downtime and safeguarding product quality could mean making proactive investments in new, longer-lasting production assets.

• Use predictive maintenance. Ensuring machine uptime and longevity might also involve using predictive maintenance. Many new production machines come with Internet of Things (IoT) intelligence built in.

• Retrofit legacy equipment for modern intelligence. Some companies offer retrofits for legacy machines. Equipment that won’t need replacement for several years can still be upgraded to provide useful telematics relating to consistency and quality.

Regarding IoT-based predictive maintenance, experts have observed key advantages for pharma manufacturers and distributors. These include increased machine availability and more efficiently deployed maintenance staff.

2. Identify shortcomings in packaging

As many as 50% of pharmaceutical recalls can be traced to problems with labelling or artwork on the packaging.

Additionally, regulatory bodies have responded to several incidents involving faulty or mislabeled packaging, fungal growth in pharmaceutical products and hundreds of millions of dollars in lost profits due to recalls.

Packaging is a significant factor in maintaining quality in pharmaceutical manufacturing and distribution. Pharmaceutical packaging must be:

• Robust enough to survive handling by multiple carriers;
• Insulated to keep perishable contents in safe, salable condition; and
• Marked to avoid misidentification, incorrect shipments and mis-dosage.

If it’s been several years since a company did a deep dive into the effectiveness of its product packaging and packaging machines, now is an ideal time. Ongoing shortages of truckers, rigs and available space—and the hoarding of warehouse space—mean every manufacturer needs packaging designed to use what’s available efficiently.

The world is also scrambling to improve its delivery infrastructure for highly perishable pharmaceutical products, like vaccines, and direct-to-consumer shipments of other temperature- and time-sensitive medicines. Manufacturers and distributors need to know that their packaging can keep their products safely insulated against variable outside conditions, be it the back of a freight truck or the beating sun on a customer’s doorstep.

This is also the right time to go through maintenance tickets and product-quality records to trace any ongoing problems to individual packaging machines to see if any are ready for replacement. Even minor safety hazards are red flags and signs upgrades might be due.

3. Switch to digital compliance and data-integrity tools

Another way to increase quality in pharmaceutical manufacturing and distribution is to invest in technologies that make recording and managing quality-control and compliance data a snap. This industry is subject to stricter regulations than most, and these rules also encompass information integrity.

Pharmaceutical companies can switch to digital data recording to improve the efficiency of their processes, raise the average quality of outgoing products and improve response times for quality-impacting events. Electronic data systems can:

• Make test results instantly available to stakeholders during pharmaceutical production;
• Generate compliance documents and other reports automatically and make them available upon completion of each batch;
• Greatly reduce the likelihood of transcription errors associated with paper bookkeeping; and
• Alert the appropriate parties when recorded data falls outside expected ranges.

Digital data-recording systems in pharmaceutical supply chains are almost always paired with cloud storage and distribution systems. This gives stakeholders from the laboratory floor to the C-suite access to the same updated information and “single source of truth.”

The ability to respond to outlier events, transcribe data automatically, receive automated quality control (QC) flags and share information seamlessly with every scientist and corporate stakeholder is a huge win for improving quality. The U.S. FDA and the European Medicines Agency (EMA) offer guidance on applying good manufacturing practices to digital record-keeping.

4. Keep watching for other value-adding technologies

The case for applying emerging technology to pharmaceutical manufacturing and distribution is already strong, based on the adoption rate of digital record-keeping technologies. What else is on the horizon?

Robotics is one of the missing links in this growing network of machine sensors, IoT devices and software automation. Manufacturers are quickly realizing the benefits during the performance of repetitive tasks such as packing, filling capsules, grinding ingredients, measuring and portioning. These are some of the riskiest specialized roles in product quality and consistency in the hands of fallible humans. Robots can perform all these tasks continually, correctly and consistently.

This technological investment shows how much catching up pharma manufacturing and distribution has to do. The industry presents a contradiction: Just one drug batch might be valued at several million dollars as it rolls off the production line, but the digital infrastructure for ensuring its value isn’t there most of the time. About 87% of surveyed pharmaceutical executives admitted their organizations have a poor digital culture.

Some techniques mentioned here prime companies for even more impressive investments, such as robotics. However, there must be an underlying infrastructure for sending and receiving data between labs, factory floors and the C-suite before bringing mechanical automation or artificial intelligence into the picture.

Companies should start slowly and logically with their technology investments and be deliberate about identifying problems before buying into an offered solution.

How to increase quality in pharmaceutical manufacturing and distribution

The pharmaceutical manufacturing and distribution sectors are under unique pressure from rising competition, strict regulations, technological disruptions and public health crises. This is a time of record-breaking research and development spending, but innovations can’t come at the cost of consistency and quality. Spending on the tools and systems that keep product quality high and protect end-users shouldn’t lag behind other entries on the balance sheet.