Manufacture and supply, science and regulation towards high-quality medicinal products
Evolution of pharmaceutical inspection in Singapore and international benchmarking to PIC/S -- ASEAN harmonization on pharmaceutical inspection and MRA implementation -- Developing a training and continuous training program for ASEAN inspectors -- WHO listed authority and other international relianc...
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| Format: | UnknownFormat |
| Sprache: | eng |
| Veröffentlicht: |
Singapore, Hackensack, New Jersey, London
World Scientific
2025
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Tag hinzufügen | Zusammenfassung: | Evolution of pharmaceutical inspection in Singapore and international benchmarking to PIC/S -- ASEAN harmonization on pharmaceutical inspection and MRA implementation -- Developing a training and continuous training program for ASEAN inspectors -- WHO listed authority and other international reliance/harmonization initiatives -- Compliance of pharmaceutical manufacturers to PIC/S GMP standard -- Manufacturing high-quality medicinal products -- Stability and shelf-life testing of medicinal products -- Good documentation practice and pharmaceutical data integrity -- Biopharmaceutical products -- Nanomedicines -- Novel and traditional vaccines -- Cells, tissues and gene therapy products -- Hand sanitizers -- Pharmaceutical dosage forms -- Active pharmaceutical ingredients -- Pharmaceutical excipients -- Traditional and herbal medicinal products -- Health supplements -- Online pharmacies and e-commerce medicinal products -- Psychotropic substances and narcotic drugs -- Looks are deceiving -- Nitrosamine saga and control of impurities -- Lapses in global GMP compliance and impact on product quality -- Making vaccines for the world with mRNA and novel technologies -- Industry 4.0 and emerging trends in pharmaceutical manufacturing -- Quality by design (QbD) and process analytical technology (PAT) -- Continuous (pharmaceutical) manufacturing -- The future of pharmaceutical inspection -- Hard and soft skills, and mindsets needed in a volatile, uncertain, complex and ambiguous (VUCA) world. "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." |
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| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | xx, 794 Seiten Illustrationen |
| ISBN: | 9789811295492 978-981-12-9549-2 |