MANUFACTURE & SUPPLY, SCI & REGULATION TOWARDS HIGH-QUALITY

In this book, readers will get to understand quality and safety issues relating to a myriad of medicinal products not previously covered in a single treatise. These range from traditional medicines, herbal formulations, and health supplements, to modern pharmaceuticals and biopharmaceuticals, to frontier technologies such as recombinant proteins, monoclonal antibodies, novel and traditional vaccines, cells, tissues and gene therapy products. The upstream manufacture and assurance of quality and supply chain integrity for active pharmaceutical ingredients and excipients, as well as their challenges, are being given their due attention here. Quality and safety issues arising from product contamination and adulteration, as well as falsified and counterfeit medicines, have also been highlighted, together with their trends and proposed solutions to combat these sub-standard and spurious medicines. Concurrently, the text examines the risks and opportunities, as well as the challenges and benefits, faced by pharmaceutical manufacturers, regulatory authorities and consumers. It elaborates on how these key stakeholders can work together to achieve a win-win-win outcome via ongoing national, regional and global partnerships, collaborations, harmonization and reliance initiatives. New and emerging issues confronting the pharmaceutical sector, such as online pharmacies and medicinal product e-commerce, quality by design, continuous manufacturing, pharmaceutical data integrity and Industry 4.0, have also been weaved into its content. This book is a comprehensive collection of published papers, lecture materials and current practical research work for the pharmaceutical and biopharmaceutical industry and serves as a one-stop reference for its wide range of readers.