Topics

Facilities & Equipment

PE Topic Image

Articles should discuss process equipment, the design of facilities, and utility systems that support the critical physical and chemical requirements of drug products, in addition to other aspects of the product specification. Topics include design and construction/installation, commissioning and qualification, operation and maintenance, and controls and automation.

View Articles

Information Systems

PE Topic Image

Topics should cover the financial impact of data management systems on drug development, manufacturing, and distribution; the basic computer system life cycle model as well as the activities and software quality assurance practices in each phase; and the controls and methods necessary to maintain data integrity and security.

View Articles

Product Development

PE Topic Image

Articles should explore the interactions of multidisciplinary functions and discuss the scientific application of experimental design methodologies as part of the product manufacturing process. Individual topics could include formulation, clinical phases, manufacturing, technology transfer, production scale-up, and optimization.

View Articles

Production Systems

PE Topic Image

Articles should focus on 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, dynamically controlling, and automating manufacturing and warehousing operations. Articles could highlight production unit operations, management, and control.

View Articles

Quality Systems

PE Topic Image

Articles should focus on the role and elements of a quality management system and its impact on the overall risk management approach, as well as its implementation in a scientific and pragmatic manner. Case studies could demonstrate the purpose, elements, and implementation of risk management and a quality management system and systems validation.

View Articles

Regulatory Compliance

PE Topic Image

Articles should highlight regulations and guidance issued by the international regulatory bodies and coalitions. Case studies could demonstrate the application of regulations and industry-generated guidance for global harmonization of compliance and product registration. Topics could include regulations, standards, practices, and guidance related to drugs, the environment, health, and safety.

View Articles

Research & Development

PE Topic Image

Articles should illustrate sound research methods and results describing innovative methods and techniques in all aspects of the industry, including manufacturing and applied pharmaceutical science and technology, process and product understanding, and control.

View Articles

Supply Chain Management

PE Topic Image

Articles should feature key components and financial impact of supply and distribution chains. Topics focus on the systems required to control and automate the receipt, storage, and dispensation of raw and packaging materials, as well as storage and distribution of finished products. Other topics could include materials management, operational economics, and warehouse and distribution management.

View Articles