The regulatory landscape of the biologics market is constantly evolving, placing significant focus on cGMP compliances. Biologics manufacturers must remain cGMP compliant to both ensure their products meet safety, quality, and efficacy standards necessary to obtain approval from international health agencies such as the FDA and EMA and maintain a competitive edge with the associated cost-saving benefits.
However, remaining cGMP compliant presents additional challenges for manufacturers. Leading biologics manufacturers must foster a culture of product quality throughout all levels of the organization, placing continuous emphasis on product innovation, process intelligence, and continual improvement of existing processes via internal audits and other approaches. Explore how to navigate the challenges of incorporating cGMP standards and realize the potential to reduce costs by optimizing processes and producing higher quality products or services.