John Darby, M.Sc., Senior Director of Lachman Consultants, wrote a recent article for Contract Pharma applying the principles of Quality Risk Management to get medicines to market faster.
Here is a brief excerpt from the article:
“As vaccine development progresses globally to address the coronavirus pandemic, assurance of manufacturing capability to address supply needs is critical to successful treatment and eradication of the virus.”
The article also discusses broadly the concepts of Quality Risk Management, and how it applies to getting products to market faster.
As we continue to understand the evolution of our field’s processes, guidance, and regulations; planning for the “return to normal” may be top-of-mind.
The FDA recently released an industry guidance titled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency, which also discusses Quality Risk Management, and the need to do this to prevent drug shortages of essential medicines during and after the pandemic.
If you are involved in development of vaccines or medicines to combat COVID-19, or are discussing and planning for resumed “normal” manufacturing operations, involve our experts to help align yours with Quality Risk Management, facility, processes, documentation, and all aspects of Good Manufacturing Practices (GMPs).