About Pharmaceutical Engineering
Editorial Mission and Focus
Pharmaceutical Engineering is ISPE’s bi-monthly technical magazine published for Members engaged in all aspects of research, development, and manufacture of safe and effective medicines and medical devices. The magazine covers topics important to the global pharmaceutical industry across all sectors, including traditional pharmaceuticals, biotechnology, innovator and generics. Pharmaceutical Engineering presents valuable information on the latest scientific and technical developments, regulatory initiatives and innovative solutions to real-life problems and challenges through practical application articles and case studies. Technical articles are peer reviewed by an expert editorial review board and will define and demonstrate global best practices in engineering and design; product development; technology transfer; manufacturing process development and scale-up; commercial manufacturing; quality and compliance; and product lifecycle management. Special features and guest editorials will focus on new technology, contemporary quality management practices and production innovation.
Pharmaceutical Engineering has introduced eight new departments, including: facilities and equipment, information systems, product development, production systems, quality systems, research and development, supply chain management and regulatory compliance.
Industry Hot Topics
In addition to the departments, each issue will feature a cover story or lead article on industry relevant hot topics, including biosimilars, breakthrough therapies, next generation manufacturing, quality metrics, quality risk management, supply chain integrity and sustainability.
More on Department Topics
Facilities and Equipment case studies illustrate how the selection of process equipment and the design of facilities and support utility systems consistently deliver the critical physical and chemical requirements of drugs products, as well as all other aspects of the product specification. Individual topics could expand into the areas of design and construction/installation, commissioning and qualification, operation and maintenance and controls and automation.
Information Systems articles report on the financial impact of the different types of data management systems that are integral to successful drug development, manufacturing and distribution; the basic computer system life cycle model and the activities and software quality assurance practices in each phase; and the controls and methods necessary to maintain data integrity and security.
Product Development articles explore the interactions of multidisciplinary functions and the scientific application of experimental design methodologies and explain a process to reproducibly and economically manufacture a product. Individual topics could expand into the areas of formulation, clinical phases, manufacturing, technology transfer and production scale-up and optimization.
Production Systems articles demonstrate the full range and scope of unit operations and production steps for manufacturing APIs, both small molecule and biologic pharmaceuticals, the building and critical process utility systems that support the manufacturing process, as well as the means of managing and dynamically controlling, and automating manufacturing and warehousing operations. Specific articles could highlight production unit operations, management and control.
Quality Systems articles focus on the role and elements of a quality management system and its impact within the overall risk management approach, as well as its implementation in a scientific and pragmatic manner. Specific case studies demonstrate the purpose, elements, and implementation of risk management and a Quality Management System (QMS) and systems validation.
Regulatory Compliance articles highlight international regulations and guidance issued by regulatory bodies and coalitions which shape the world’s current pharmaceutical-related requirements and future directions. Case studies could demonstrate the application of regulations and industry-generated guidance for global harmonization of compliance and product registration. Specific topics could include government regulations, standards, practices and guides related to drugs, environmental, health and safety.
Research and Development articles illustrate on sound research methods and results describing new and innovative methods and techniques used by pharmaceutical professionals serving all aspects of the industry, including manufacturing and applied pharmaceutical science and technology, process and product understanding and control.
Supply Chain Management articles feature the key components and financial impact of supply and distribution chains. Articles focus on the systems required for dynamically controlling and automating the receipt, storage and dispensing of raw materials and packaging materials, as well as storage and distribution of finished products. Individual topics typically include materials management, operational economics and warehouse and distribution management.
Pharmaceutical Engineering readers
Pharmaceutical Engineering readers
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA, as well as offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for additional Society news and information.