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5 pharma manufacturing trends and tips to capitalise on them

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Katie Farley, director, product management at MasterControl, explores five pharmaceutical trends, what’s driving them, and how adopting them can lead to eliminating manufacturing errors, enhancing performance, and gaining a competitive advantage.

Key insights:

Early in 2021, millions of doses of the COVID-19 vaccine from two pharmaceutical manufacturers were rendered unusable due to manufacturing problems. Investigations into the issues at both facilities determined that the incidents were a result of human error.

Pharmaceutical companies are under constant pressure to develop and distribute medicinal products in a short amount of time. Speed, quality, and safety are high priorities in an industry where there is little to no margin for error. Still, in pharmaceutical manufacturing, production errors and delays are creating an unacceptably high occurrence of product recalls and shortages. In a report to the United States Congress regarding human drug and biological product shortages in 2021, the U.S. Food and Drug Administration (FDA) acknowledged the impact these shortages have on patient care. The agency is currently doing what it can within its authority to alleviate the associated disruptions to health care.

While the FDA is engaged in overcoming product shortage concerns, pharmaceutical manufacturers are encouraged to be more proactive with measures to identify and mitigate errors and improve manufacturing efficiency. However, when the global health crisis hit, these endeavours became more challenging for companies because of the disruption to business operations. Organisations needed to shift their focus to making the necessary adjustments to the business in order to continue functioning.

Almost immediately, social distancing mandates compelled companies to rely more on technology to maintain business functions with a remote workforce. The day-to-day efforts of maintaining productivity, supply chains, release schedules, etc. while scaling the hurdles of changing regulatory guidelines are daunting enough. But these tasks are even more challenging when employees and stakeholders are dispersed across several locations.

Despite the challenges companies faced during the height of the pandemic, many aspects of this new operational approach, such as employees interacting remotely, could become the norm — outside of the manufacturing/production staff that need to be on the shop floor. Therefore, many of the current trends influencing pharma manufacturing surround this new organisational paradigm, and the primary focus is on digitisation of operations. COVID-19 was an impetus for implementing advanced technologies, and now modernisation is essential to becoming more agile and ensuring long-term relevance in the value chain.  

1. Digitisation reduces errors and improves production

In June 2019, the FDA issued a warning letter to a drug manufacturer. The list of violations included the company’s failure to prepare batch production and control records with complete information. Specifically, a leak during aseptic filling operations was observed the previous year. The company failed to document that leak as well as other mechanical interventions in the batch record.

Paper batch records are a common component in pharma manufacturing. Unfortunately, this form of record management is at the core of many manufacturing errors. Digitising batch records is key to overcoming inefficiencies and delays in manufacturing because the technology will not allow incorrect, missing, or out-of-date entries. Digitisation also provides business advantages. According to a 2019 report by McKinsey and Company, modernised digital systems resulted in an 80% reduction in deviations, more than 50% faster closure times, and up to 25% reduction in production costs.

2. Advanced analytics enhances shop floor operations

Advanced technologies such as artificial intelligence (AI) and its associated technologies, machine learning (ML) and natural language processing (NLP), are redefining the parameters of what is possible in pharmaceutical product development. By discontinuing the use of paper and employing modernised data management tools, it’s easier to stay up to date on all aspects of manufacturing. Using historical and new data along with analytical queries and ML algorithms, companies can forecast quality events, maintenance, behaviour, trends, etc. Stakeholders can analyse complex data sets in a fraction of the time it takes with manual processes.

More pharma manufacturing companies are employing AI to identify specific areas or processes causing delays. For example, an AI algorithm can tell a line supervisor the exact reason a batch has fallen behind the expected time target.

3. Modern supply chains are enhancing visibility

In a 2020 report focusing on the root causes of drug shortages, the FDA cited that issues with the supply chain significantly contribute to product shortages. Specifically, supply chains have become longer, more complex, and fragmented. This makes it difficult to establish visibility and manage quality across the supply chain.

Quality and efficiency should always be priorities with supply chain management. To adequately manage and track suppliers effectively, implement technologies that can foster a more participatory and collaborative environment. A digitised quality management system (QMS) enhances supplier accountability, communications, and governance, which alleviates supply chain blind spots, vulnerabilities, and risks.

4. Regulatory processes urge modernisation

The COVID-19 lockdown impacted the business processes of regulatory agencies. Travel restrictions prevented auditors from conducting on-site inspections, but pharma products still needed to get on the market. To meet its regulatory obligations, the agency employed alternative approaches to medical product oversight. For pharma manufacturers, the FDA introduced remote interactive evaluations. These involve the use of various interactive tools to remotely evaluate a company’s manufacturing facilities, processes, and documentation.

The European Medicines Agency (EMA) experienced similar limitations regarding travel for on-site inspections. The agency considered remote audits on a case-by-case basis. These included observing activities, interviewing personnel, and reviewing requested documents. In a Q&A document on regulatory expectations during the COVID-19 pandemic, the agency emphasised that when hosting remote inspections, the company must meet the technical requirements to provide remote access to the facility and documentation.

A key component of the remote oversight is enabling inspectors to review documents in electronic format prior to the online meetings. To meet this requirement, companies using paper records and documents need to scan all the requested documents to create electronic versions. Given the large number of pages that need to be scanned, the process is time-consuming and at risk of not capturing all the pages in large documents.

Remote documentation reviews require more planning and preparation to enable auditors to efficiently conduct an evaluation. Regulatory agencies expect requests for documents to be satisfied within a reasonable timeframe. Digitising documentation processes enables companies to centralise their records and documents, which ensures success in meeting document request turnaround times. In addition to document accountability, companies are better prepared for all phases of an evaluation, resulting in shorter review cycles.

Currently, for the FDA there are no plans to replace on-site audits with remote inspections. However, some of the remote processes, such as reviewing batch records and other required documents in electronic format, could be incorporated in the agency’s standard operating model. Remote document reviews and inspections are easier to facilitate with a digitised operation.

5. Digitisation drives scientific breakthroughs

In August 2021, Pfizer inked a deal to purchase Trillium Therapeutics as part of its commitment to innovation and scientific breakthroughs. To become a leader in the pharmaceutical market, companies need to revisit their business models to become more agile in pursuing opportunities to expand their contributions to the value chain. In addition to speeding up time-to-market and reducing operational costs, modernisation is key to growing market share and revenue.

Digitising operations eliminates siloes by fully integrating the organisation’s quality management system (QMS), enterprise resource planning (ERP), manufacturing execution system (MES), etc. Stakeholders can automatically transfer data to other systems and functional areas and make real-time line adjustments to minimise misallocations, rework, and waste.

Today more than ever pharmaceutical manufacturers need to evolve faster in order to stay current with the new trends driving the industry. The implementation of advanced technologies and best practices that improve efficiency, speed, and adaptability gives enterprises a competitive edge and ensures long-term relevance in the industry.

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