The "Pharmaceutical Manufacturing Handbook: Production and Processes" is a comprehensive reference for the pharmaceutical business that covers issues such as formulation development, process development, quality control, and regulatory compliance. This guidebook is intended to offer an overview of the complete pharmaceutical manufacturing process, from medication research through final production and quality control.
The guide begins with an introduction to the pharmaceutical business, followed by a review of the regulatory environment and a discussion of the various stages of drug development. It then discusses several areas of pharmaceutical manufacturing, such as formulation development, process development, and quality control.
In the formulation development section, the handbook covers the various types of drug formulations, such as solid dosage forms, liquid dosage forms, and semisolid dosage forms. It also discusses the factors that impact formulation development, such as drug solubility, stability, and bioavailability.
The handbook's process development section covers the many steps of pharmaceutical manufacture, including as manufacturing, packing, and labeling. It also examines the several process technologies utilized in pharmaceutical manufacturers, such as continuous manufacturing, as well as the significance of process optimization and control. The handbook's section on quality control discusses the many quality control methods used in pharmaceutical production, including as analytical methods, physical methods, and microbiological methods. It also goes over the significance of quality assurance in the pharmaceutical sector as well as the regulatory criteria for quality control.
The final section of the handbook covers regulatory compliance, including the various regulatory bodies involved in pharmaceutical manufacturing, such as the FDA and EMA, and the various regulations that govern pharmaceutical manufacturing, such as cGMP and ICH guidelines.
Overall, the "Pharmaceutical Manufacturing Handbook: Production and Processes" is a valuable resource for anybody involved in pharmaceutical manufacturing, including researchers, engineers, and quality control specialists. It covers the various regulatory requirements that must be met to ensure that pharmaceutical products are safe and effective, and provides a comprehensive overview of the entire pharmaceutical manufacturing process, from the initial stages of drug development to the final stages of production and quality control.
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years of experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
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