There is literally no person who can live without the help of medicine. At some point or another in their lives, people have to rely on medicine. Medicine is the outcome of the pharmaceutical industry, which owns a large portion of the manufacturing domain. By nature, this industry is complex and prone to irreversible consequences if one tiny action goes wrong. This is why pharma manufacturers are very keen on perfection during the manufacturing process, and even in a situation like that, the challenges they face during the production framework are uncountable!
This article is going to reveal everything about the challenges the pharma manufacturing industry is facing in today’s competitive market.
What is Pharma Manufacturing?
Though we just mentioned that this is the industry that produces medicine, it is not enough to make you understand its depth. Pharmaceutical manufacturing is the process of producing drugs and medications on a large scale. The complexity of it is that, unlike other manufacturing domains, this sector has to put 95% of its weight on attention to ensure they meet strict quality, safety, and efficacy standards. Some of them are implemented by the World Health Organisation (WHO), while others are put in place by industry itself.
You can understand the seriousness of this type of business as it involves several stages. This includes drug discovery, formulation development, production, packaging, and distribution. If elaborated more deeply, the manufacturing process begins with the synthesis of active pharmaceutical ingredients (APIs) or sourcing them from external suppliers. The next stage is where these ingredients are formulated into dosage forms such as tablets, capsules, or injections, adhering to quality standards.
In order to guarantee purity and uniformity, quality control procedures are used at every stage of production. So, what is next? Packaging with use instructions and labelling is on the line! Here, the manufacturers have to pay attention to regulatory compliance. If the manufacturers fail to follow rules established by health authorities to ensure the efficacy and safety of their products, there will be penalties or more serious consequences.
This is an industry that is evolving unstoppably. More and more pharma companies in the Singaporean market are trying continuous improvement efforts aimed at enhancing efficiency and reducing costs while maintaining high-quality standards. This is because it has become an essential part of human life.
Top 5 Challenges Faced in Pharma Manufacturing
Product Quality Standards
Maintaining product quality standards presents a multifaceted challenge for pharmaceutical manufacturing. As we said before, the manufacturing processes can vary from region to region or company to company, but the overall product quality standard should remain the same!
Did you know that stringent regulatory requirements demand adherence to Good Manufacturing Practices (GMP)? Yes, this practice is all about gathering precise control over every aspect of production, from raw material sourcing to packaging and distribution. However, these also do not stay in one position for so long. This means these standards evolve continually, requiring continuous adaptation and investment in updated infrastructure and processes.
Further, new factors that could have an impact on product quality are introduced by the growing complexity of medication formulations and manufacturing processes. It gets harder and harder to ensure consistency between batches and reduce variances, especially when dealing with international supply chains and outsourcing.
We should not forget that there is another fact that challenges the quality of the product. That is, unexpected events such as equipment failures or supply chain disruptions. The latter can compromise quality, for sure. This is where you need robust contingency plans and risk management strategies.
Data Privacy and Security
When the whole business world is dominated by data privacy breaches, what saves the pharma industry from that challenge? No, data protection poses a top challenge for pharmaceutical manufacturing as well. This is due to the sensitive nature of the information involved. You know that pharmaceutical companies handle vast amounts of proprietary data related to drug formulations, manufacturing processes, clinical trials, patient information, and whatnot.
Protecting individual privacy, upholding legal compliance, and preserving intellectual property all depend on the security and confidentiality of this data. However, the rapid growth of digital technology and the interconnectedness of contemporary industrial systems make them more vulnerable to cyber threats like ransomware attacks, data breaches, and theft of intellectual property.
Moreover, compliance with data protection regulations such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) adds complexity to the whole industry, requiring robust data encryption, access controls, and monitoring mechanisms.
If the pharma manufacturing industry wants to stay away from this barrier, they have to implement a set of sophisticated safety protocols and robust technologies to put a tight grid on their data volumes.
No Unification among Processes
The lack of unification among processes is one way of contributing to the downfall of the entire business of pharmaceutical manufacturing. This leads to inefficiencies, inconsistencies, and increased risks, for sure. It is true that the production process occurs separately. However, unification is what is required to bring forth the best outcome in the end.
The whole manufacturing lifecycle, from research and development to production and distribution, is affected by this division when it comes to visibility, cooperation, and communication.
As a result, it becomes difficult to maintain consistency in product quality, regulatory compliance, and supply chain management. Plus, inefficient procedures and repeated work result in resource waste and higher expenses. Making adjustments or enhancements becomes difficult in the absence of a unified strategy, which restricts creativity and flexibility in reacting to legal or market needs.
Integrating with Technology
The pharmaceutical industry has always used various systems or technologies to expedite the process. No matter how much software is being implemented within the manufacturing framework, they all need to work together in the end!
But integration has become a concern for pharmaceutical manufacturing due to several factors. Let us explain this. You know that the industry operates within a highly regulated environment, where any technological implementation must comply with stringent standards such as Good Manufacturing Practices (GMP) and data integrity requirements, as we stated above.
Plus, there can be various traditional systems in use. Careful planning and validation procedures are necessary to ensure that new technologies fulfil these criteria while increasing productivity and preserving product quality. But the actual matter is that these procedures can be resource- and time-intensive.
Change of Demands
Every day, we see new trends and inventions coming to the pharma market. This is where the pharmaceutical manufacturers have to be very careful after all. Why is that? Shifts in market trends, regulatory requirements, and healthcare needs can rapidly alter the demand for specific medications in the first place. Another fact is that it needs agility and flexibility in the production processes from the initial point to the end.
Meeting these evolving demands is not as easy as it seems. The latter requires adjustments in production schedules, formulation variations, and supply chain management, which can strain resources and disrupt existing workflows.
On the other hand, sudden spikes in demand, such as during pandemics or regulatory changes, can lead to supply shortages or excess inventory if not adequately anticipated or managed.
Cerexio Technologies as the Best Solution
Since Cerexio solutions are powered by Industry 4.0 digital capabilities, we can cater to any requirement, expressing high levels of flexibility in the entire implementation process. Holding hands with Cerexio is the best answer you can have to face the pharma manufacturing industry-focused challenges.
Walking Towards Uninterrupted Success in the Pharma Industry
You cannot stay away from the ongoing challenging situations, for sure. But what you can do is find innovative answers to the pharma manufacturing concerns. With the right solutions, you are empowered to proceed with your expectations.
