Wah C.L., Hock S.C. Manufacture and Supply, Science and Regulation Towards High-Quality Medicinal Products

World Scientific Publishing Co. Pte. Ltd., 2025. — 812 p. — ISBN: 9789811295492In 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.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
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