Lequina is Senior Director, Quality Assurance and Regulatory Affairs at Phenomenex (a Danaher Company). She is an experienced quality and regulatory leader with over ten years of experience in process and organizational development, quality, continuous improvement and project management. Lequina has a demonstrated history of working in the medical device and pharmaceutical industry.
Quality management systems — applying good distribution practices to the biopharmaceutical supply chain
Biopharmaceutical supply chain strategies and alignment with good distribution practices (GDPs) are often viewed and planned with a focus on the post-marketing stage. Although this approach is valid, GDP compliance and supply chain strategies have important implications even during the clinical phases of product development. GDP regulations ensure that the integrity of medicinal products is maintained throughout all stages of the supply chain, from the manufacturer’s site to the pharmacy, or person authorised to supply to the public.