Manufacture and Supply, Science and Regulation Towards High-Quality Medicinal Products

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.

Contents:

• About the Authors
• Preface
• Acknowledgements
• Journey Towards Being 1st Asian PIC/S Member and Beyond:
  • Evolution of Pharmaceutical Inspection in Singapore and Benchmarking to PIC/S
  • ASEAN Harmonization on Pharmaceutical Inspection and Mutual Recognition Arrangement Implementation
  • Developing a Training and Continuous Training Program for ASEAN Inspectors
  • WHO Listed Authority and Other International Reliance and Harmonization Initiatives
• GMP Compliance and Manufacture of High-Quality Medicinal Products:
  • Compliance of Pharmaceutical Manufacturers to Good Manufacturing Practice Standards
  • Manufacturing High-Quality Medicinal Products
  • Stability and Shelf-Life Testing of Medicinal Products
  • Good Documentation Practice and Pharmaceutical Data Integrity
• Manufacture and Supply, Science and Regulation of Medicinal Products:
  • Manufacture and Supply, Science and Regulation of Biopharmaceutical Products
  • Manufacture and Supply, Science and Regulation of Nanomedicines
  • Novel and Traditional Vaccines
  • Cells, Tissues, and Gene Therapy Products
  • Hand Sanitizers
  • Pharmaceutical Dosage Forms
• Assuring Quality and Supply Chain Integrity of Starting Materials and Other Health Products:
  • Assuring Quality and Supply Chain Integrity of Active Pharmaceutical Ingredients
  • Assuring Quality and Supply Chain Integrity of Pharmaceutical Excipients
  • Assuring Quality and Supply Chain Integrity of Traditional and Herbal Medicinal Products
  • Assuring Quality and Supply Chain Integrity of Health Supplements
  • Assuring Quality and Supply Chain Integrity of E-Commerce Medicinal Products/li>
  • Assuring Supply Chain Integrity of Psychotropic Substances and Narcotic Drugs
• Contaminated, Adulterated, Counterfeit, Falsified and Substandard Medicinal Products:
  • Looks Are Deceiving: Adulterated, Counterfeit, Contaminated and Falsified Medicinal Products
  • Nitrosamine Saga and Control of Impurities in Active Pharmaceutical Ingredients and Pharmaceutical Products
  • Lapses in Global Good Manufacturing Practice Compliance and Impact on Product Quality
• Industry 4.0 and Emerging Pharmaceutical Technologies:
  • Making Vaccines for Supply to the Whole World: Challenges and Benefits
  • Industry 4.0 and Emerging Trends in Pharmaceutical Manufacturing
  • Quality by Design and Process Analytical Technology
  • Continuous Manufacturing
  • The Future of Pharmaceutical Inspections
• Conclusion: Skills and Mindsets Needed by Manufacturers and Inspectors in Industry 4.0
• Bibliography
• Index

Readership: University professors and researchers, undergraduate and post-graduate students in pharmacy, pharmaceutical science, life sciences and related disciplines. Medicines regulators and pharmaceutical inspectors. Manufacturing and QC professionals from the global pharmaceutical and biopharmaceutical industry, pharmaceutical scientists, pharmacists, medical practitioners, clinical researchers, nurses. biotechnologists, molecular biologists, biomedical scientists in academic, public and private sectors. The educated reader interested in contamination, adulteration, counterfeits and falsified medicines, drug safety, manufacturing, quality control, distribution and its supply chain integrity.