BioPharm International - March 2023

BioPharm International - March 2023

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10 BioPharm International ® Quality and Regulatory Sourcebook March eBook 2023 www.biopharminternational.com F acing new global challenges, pharmaceuti- cal company leaders are looking to prioritize operational strategies to remain competitive in this rapidly evolving business environ- ment. Recent events that range from the COVID-19 pandemic to new regulatory guidelines to econom- ic inflation have required pharma manufacturers to find new ways to streamline workflows and min- imize risks. Disruptions caused by the pandemic and related restrictions continue to impact supply chains and logistics worldwide. Additionally, many companies have shifted toward remote and hybrid working, and have increased their use of digital technologies to maintain business continuity and pro- tect the health of employees. At the same time, pharmaceutical manufacturers are coping with personnel challenges such as fewer senior managers to oversee laboratories and supervise employees. Staffing is becoming an increasing issue in the pharmaceutical space, as the US Bureau for Labor Statistics states that occupations across life, physical, and social sciences are expected to rise by 7% by 2031 (1). This surge in job openings means that increased staff turnover has heightened the need for onboarding proce- dures, particularly given the variety of skillsets brought by newly hired staff members. Wider labor market trends also contribute to talent shortages, and a 20% in- crease in demand for science, technology, engineering, and mathematics (STEM)-related roles in life sciences in the United States, combined with a 14% shortage in pharma digital talent (2), increases pressure on lab man- agers to find the right people who can keep pace with the demands of a modern laboratory. The rise in remote working also plays a role, as labs are also tasked with the adoption of flexible, hybrid approaches to work. All of these challenges contribute to increased pres- sure on technicians, as these members of the lab are in- creasingly being asked to take on more work and deliver results faster than ever before, complicating training procedures and requiring more supervision. Mitigating Human Error and Supporting Compliance with Smart Technology Mike Wilson, QA/QC Strategy, Waters Corporation Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes. PHOTON_PHOTO - STOCK.ADOBE.COM

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