Global health authorities play a significant role, ensuring the safety and efficacy of approved drugs—for new innovations and already existing products. ISPE takes pride in the strong regulatory presence we bring to all...
James Breen, Jr., PE, 2018–2019 Chair, ISPE International Board of Directors, Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals, shares how at the heart of the ISPE Annual Meeting & Expo is an opportunity...
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.
Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of...