Pharma Manufacturing: Top 10 Pitfalls to Avoid

Executive Summary

In addition to the logistics of coordinating production, labor, and distribution, and an increasingly complex supply chain, life sciences manufacturers face additional challenges. The ever-evolving regulatory environment, coupled with new and continually improving delivery methods demands an equally rigorous risk management strategy. 

Modern technology plays a key role in not only helping pharmaceutical manufacturers mitigate immediate risk, but future-proof their plans and procedures for the long term.

In this white paper, we’ll examine 10 of the most commonly encountered pitfalls in this space, along with our recommendations on how to avoid them.

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Industry Challenges

Modern manufacturers face constant challenges. The logistics of coordinating an increasingly complex supply chain, production, labor, and distribution make for a mosaic of continually moving parts and procedures.

Life science manufacturing, however, faces additional hurdles and obstacles. Impurities and deviations mean more than just a sub-par consumer experience: with pharmaceutical products, the health and lives of the patients who consume them are on the line.

“The pharma supply chain has never been as complex and distributed as it is today and this will continue. There are many business difficulties posed by complex supply chains:

• Managing a portfolio of products across the drug lifecycle stages
• Knowing where and when products can be manufactured
• Raw material forecasting
• Determining product maturity based on volumes
• Identifying sources of variability
• Deciding where and when to invest
• Sharing data with external organizations

Greater visibility and collaboration is critical going forward as we prepare to meet these difficulties head on.”

— Keith Bowen, Apprentice, LES and MES Advocate

Patient safety and good health outcomes are the primary drivers of pharmaceutical manufacturing. Reducing the exposure of products and processes to risk is of utmost importance.

That’s why an increasingly complex operational environment, coupled with new and continually improving delivery methods, demands an equally rigorous risk management strategy.

Let’s examine 10 of the most common pitfalls in pharmaceutical manufacturing, along with some tips on ways to stay on top of them.

As drugs and delivery systems continue to adapt and evolve, so do health and safety regulations. 

To remain competitive, pharmaceutical manufacturers must comply with those regulations at every step of the process, even when dealing with multiple jurisdictions, as the penalties for non-compliance can be severe and costly.

Three major reasons why organizations fail their audits are because the procedures either don’t meet FDA requirements, aren’t followed fully, or aren’t documented correctly. That's why it's key to ensure your data is accessible, updated, and your standard operating procedures are accurate.

A cloud-based manufacturing solution can build compliance directly into the process, so organizations can be certain they’re up to date on all regulatory requirements.

The passage from initial research and development through clinical trials all the way to commercial manufacturing requires many steps, teams, and stakeholders.

The way communication is managed can also lead to the inadvertent sequestration of valuable information, preventing the smooth transfer of essential knowledge, which elevates risk both up- and downstream.

If all teams are on the same MES and LES, there’s no chance for information to be locked in siloes. That’s why it’s crucial to find a solution that can work for all the distributed teams involved in the end-to-end drug production lifecycle.

For decades, the pharmaceutical industry has been anchored to binders full of redlined recipes and procedures, interpreted on the go by trusted employees.

When the most efficient techniques are known only by individuals and not by all involved stakeholders, the entire manufacturing process is at risk of interruption when those individuals aren’t immediately available.

The rapidly changing pace of today’s pharmaceutical manufacturing landscape necessitates a more integrated approach. Modern solutions can optimize the transfer of knowledge, from each iteration to the next, to better protect the entire process.

The making and testing of drugs demands constant refinements as that process is perfected, particularly during the preclinical development and clinical manufacturing stages. Newer modalities like cell and gene therapies also require greater variability and flexibility in execution.

Traditional manufacturing execution systems require the assistance of software engineers to manually code every change, drastically slowing the editing process and delaying development.

What’s needed instead is a flexible, adaptable system so users can edit steps, procedures, and batches as needed on the go. Look for no-code and low-code solutions that allow users to configure the system themselves, without needing a dedicated IT team to do the coding for them.

When monitoring is a manual process, it can only be reviewed periodically, as every procedure, test method, or batch requires extensive documentation.

If production is completed through a CDMO, that review becomes a patchwork process, divided into separate meetings, calls, and emails. In this compartmentalized environment, quality issues may go unaddressed.

The best way to assure product quality is by effectively capturing and reviewing batch record summary data in real time. This means finding a system that can deliver real-time data visibility.

In the pharmaceutical manufacturing space, real-time visibility means that data can be instantly viewed across sites and shared across teams. In other words, as soon as it’s captured, it’s instantly available to anyone involved in the drug manufacturing lifecycle.

The massive supply chain disruptions of the global pandemic meant that equipment and materials often could not reach their intended destinations when they were needed most.

And to further complicate matters, specially trained personnel were no longer able to travel to operate complex equipment, leading to delays and even halts in vital pharma manufacturing processes.

The silver lining of this disruption is that it expedited the introduction of new manufacturing technologies to help bridge this gap. Unable to travel from site to site, or even work in person depending on the role, pharma companies started implementing cutting-edge tech solutions to maintain, and even expedite, drug development and production.

New wearable devices give experts instant access to equipment, allowing them to provide Augmented Reality (AR) enhanced, step-by-step inspection and instruction when in-person appearances are not possible. With them, teams can add augmented instructions such as AR overlays, photos, videos, and audio to each step so that in-suite operators can understand how to execute correctly the first time.

Pharmaceutical manufacturing depends on skilled professionals. The qualifications for specific academic, clinical, and technical positions may vary, but the need for expertise does not.

On-the-job training is crucial to get new hires up to speed on process and procedures. Sadly, such training is often neglected in the need to finish pressing tasks.

Fortunately, digital solutions give companies a way to train employees faster, while safeguarding their operations. The augmented environment provides an excellent opportunity for life science professionals to learn how to conduct various processes without the associated risks (such as operating expensive equipment or executing on batch production).

With real-time audio and video connections, training can be provided on-the-go, even when trainers are not physically present — keeping production moving while building team efficiency.

Crisis preparedness is an all-encompassing strategy for continued operations to make sure workflows prevail throughout ongoing difficulties.

The first step in creating a crisis management plan is to conduct a thorough analysis of needs and current challenges. Only then can priorities be set.

The data automatically collected and surfaced by an advanced MES makes it possible to rapidly perform that analysis, so leadership can prepare their responses and determine which operational activities to continue.

“Having material genealogy, equipment usage, and batch run data digitally available over the web is extremely useful for multiple scenarios. Having the data at your fingertips, so that you have everything you need to get an action plan in place.

Let’s say there was a huge crisis — a plant blowing up, etc. — your data wouldn’t be compromised.”

— Keith Bowen, Apprentice, LES and MES Advocate

While collaborating with external partners, such as CDMOs, can offer benefits like increased efficiency, access to specialized expertise, and cost optimization, it also carries certain risks.

Intellectual property concerns and the protection of proprietary information can become challenging when sharing sensitive data with external parties.

In addition, maintaining quality control and ensuring regulatory compliance throughout the collaboration process can be demanding, requiring close monitoring and coordination. And on top of this, there’s the logistics: managing timelines and aligning objectives between multiple stakeholders can be complex, potentially leading to delays or miscommunications. That’s why careful evaluation, clear communication, and robust agreements are essential to mitigate these potential pitfalls and foster successful external collaborations with contract pharma manufacturers.

“With the increase in external manufacturing that is starting to accelerate, for both new and mature pharma companies, collaboration on batch record templates and recipes is essential to streamline product manufacturing and ways of working.

Standardizing inputs and outputs to and from external partners can provide huge benefits.”
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— Keith Bowen, Apprentice, LES and MES Advocate

Traditional pharmaceutical manufacturing practices offer numerous opportunities to introduce human error.

Paper-based recipes and procedures are subject to misinterpretation. Reviewing procedures and batches is incredibly time-consuming, requiring the analysis of a lengthy record of authorizations.

Information stored in binders can be physically misplaced or even lost. Furthermore, institutional memory housed in trusted employees is subject to the risk of illness or retirement.

Digital solutions such as Augmented Work Instructions (AWI) can help to minimize human error. Instead of needing to manually record and transcribe every step on paper, manufacturers can use AR technologies to digitally manage, iterate, and execute their procedures in real time.

Closing Thoughts

‍Pharmaceutical manufacturers must manage a number of logistical issues facing all global commercial organizations, while also balancing the risks added by the delicate and consequential nature of their products.

End-to-end technology solutions can mitigate those risks, and help your organization navigate emerging and evolving pitfalls as they happen. For example, Tempo’s programmable guardrails address information silos head on by instantly flagging value deviations as they occur, while captured data is stored and can be surfaced as needed. And the system itself, rather than its users, becomes the repository of institutional knowledge.

Technology delivers real solutions to help pharmaceutical manufacturers develop their risk management strategies. CMN, Apprentice’s end-to-end Connected Manufacturing Network (CMN), allows companies to connect all their distributed teams and sites, helping to not not only mitigate immediate risk but also to strengthen and future-proof long-term plans and procedures.

Learn how to mitigate the risk of your pharmaceutical manufacturing operations with a fully compliant, end-to-end system.

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Featured Thought Leader: Keith Bowen

When it comes to risk mitigation in pharmaceutical manufacturing, Keith Bowen is the go-to resource you want on your team. And we’re lucky to have him on our team here at Apprentice!

Read on to meet Keith and learn his recommendations for pharmaceutical manufacturers.

Meet Keith

• Who: Keith Bowen
• What: LES and MES Advocate, Apprentice
• When: 1+ years at Apprentice
• Where: Dublin City, Ireland
• Why: Keith’s industry knowledge and passion for sharing it can help the pharmaceutical industry transform to meet current and new challenges.

Keith’s Background

With 25 years of experience in the life science industry, Keith is well respected for his knowledge of and experience with MES product development, solution design, system integration, implementations, and support services for both large and small MES projects.

Keith has worked with many of the Top 10 Pharma, Biotech and Medical Device companies, on both automation and MES solutions. Today, he is an MES/LES Advocate at Apprentice and works primarily with new customer engagement, interfacing between sales, product, and marketing.

Keith’s Top Take

“To make a difference in your business, whether you are managing a portfolio of products, working in internal or external manufacturing or a C(D)MO looking for better ways of handling customers… start with having a cloud native approach for your ideal future state and then work out how to get there.

The future of pharmaceutical manufacturing involves connected data networks and the use of AI for insightful decision making in real time. Apprentice offers Tempo —  one platform to turn molecules into medicine and can support you on your digital journey.”

— Keith Bowen, Apprentice, LES and MES Advocate

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