The Role of GMP in Big Pharma in the Race Toward a COVID-19 Vaccine
As the pandemic continues to be a threat, big pharma companies are racing to develop a vaccine to prevent the spread of the COVID-19 virus. Researchers have been working at a rapid pace and expectations are that we can see a vaccine within the next 18 months instead of the 10 years it would normally take. This vaccine will be required to meet the Good Manufacturing Practice (GMP) in order to be released to the public. How does the role of GMP in big pharma affect the race towards a COVID-19 vaccine? Here’s what you need to know.
There are numerous vaccines that are currently in development and undergoing clinical trials. But even if these vaccines are successful with their trials, there still may be issues that prevent it from being released on a mass level to the public. One of these issues is that a vaccine can’t be manufactured easily and quickly. The same small dose that was tested must be exactly the same as the massive batches brewing in the laboratory. According to scientists, there are massive containment and biohazard challenges to overcome to ensure the batches remain super clean.
Human error can cause more than 80% of the problems with manufacturing drugs and vaccines. Proper GMP training for error prevention is necessary for accident prevention and to avoid any other major problems from occurring. The vaccine has to have the potential to be replicated at numerous manufacturing sites in order to be mass-produced. But it must do so in a way that doesn’t compromise the quality of safety evaluations which can be highly subject to human error.
Laboratory Staff Protection
Another area where GMP training for error prevention is critical involves protecting staff from the virus while developing a vaccine. The same safety procedures that are followed by the public such as regular handwashing and social distancing must be adhered to. Visits must be prohibited and visual communication tools assist the manufacturing industry to collaborate together while keeping everyone safe.
Supply Chain Disruptions
Another area of concern for reducing human errors is with supply chain disruptions for the vaccine. To reduce shortages and disruptions, pharmaceutical labs are sourcing materials and active substances from third party suppliers. GMP training must be facilitated to ensure standards for good manufacturing practices are kept to ensure quality.
How long it will take for a COVID-19 vaccine to become available to the general public is yet to be determined. However, GMP training for error prevention can be highly beneficial for reducing human error that can slow down the production process. The future is hopeful that we will soon be able to vanquish this virus.