The most distinguishing characteristic of a pandemic is the extent of its prevalence, and COVID-19 is probably the most widespread pandemic of the century. There isn’t a corner of the globe that has not been affected by it, neither any industry nor a single individual. In this article, we take a look at the impact of COVID-19 on the pharmaceutical industry, and how this sector has risen to the challenges posed by the pandemic.
COVID-19 – the challenges
The speed with which COVID hit the world had left all of us unprepared and unequipped, without any effective measures to shield us against the impact. Among others, the pharmaceutical industry faced the challenges of:
- Disruption of the supply chain – for both raw material and finished product;
- Shortage of manpower – due to the travel constraint, local lockdown policy, and the limit on the number of employees allowed to work on-site;
- Decrease in efficiency or delayed progress – attributed to the above two factors plus the conservation of investment, decreased access to resources, and the shift in business priorities.
Globalisation had been boosting the growth of the pharma industry through the provision of alternative sources for raw materials, API, and intermediates, by opening up more overseas markets, and by bringing in talent and professionals from all over the world. These were adversely affected by the pandemic to an extent never seen in the past. The points of origin of multiple raw materials, especially some traditionally big API exporting countries, became limited due to the worsened COVID situation. The overseas inspection and approval by authorities have also been either delayed or cancelled.
COVID-19 – the changes and the opportunities
In the presence of such challenges, the pharmaceutical industry was observed to be swiftly adapting to the new situation. Strategies were laid out to address the supply chain issues, alternative sources and origins were investigated, and options of self-sufficiency were studied as well. As pharmaceuticals is a highly regulated industry, alternative materials and supplies involve more than a simple shift in procurement and distribution network. It requires the collective effort of multiple functions of the manufacturer and authority. Every aspect of the whole supply chain has to be carefully qualified to ensure patient safety.
The health authorities are also adapting their approach and procedures to support industry needs. For instance, the introduction of fast-track approval or emergency use authorisation of medicine and vaccines, and the introduction of remote inspections. The Health Sciences Authority, a statutory board under the Ministry of Health of the Singapore Government, is among the early adopters of the new methodologies. Since June 2020, HSA has begun the adoption of virtual inspections based on a thorough risk assessment.
As for manpower and resources, there will be more focus on engaging and developing local talent in the next couple of years, which will eventually contribute to the long-term local talent market.
Although the pandemic slowed down globalisation, other means and methods have come to take over earlier approaches. Thanks to technology, we can communicate over virtual platforms. Also, physical work such as commissioning and qualification can now be performed on paperless platforms like KneatGx™, which enables review and approval remotely.
On one hand, the pandemic seems to lay strict physical boundaries, but on the other hand, it greatly stimulates collaborations – companies collaborating on developing vaccines, manufacturer and academy collaborating on R&D, industry and authority collaborating on bringing the vaccine and cure to the public more efficiently, and countries collaborating on supplying the medicines to a wider population.
COVID-19 – the silver lining
Looking back at human history, it can be noticed that all the disastrous events have eventually advanced science and technology. I do believe COVID-19 will be another such event, forcing technology advancement and a shift in mindset.
We adapt and we evolve.
About No deviation
At No deviation, we partner with you to help you with executing your CQV process, troubleshooting or your CAPA, or implementing new digital solutions. Our team will come with an open mind and follow the simple steps that are Understand, Observe, Define, and Implement.
With 15 years of experience in the global pharmaceutical industry, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both Consultant and End User roles. With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.