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...
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...
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.
Good Practice Guide: Technology Transfer 3rd Edition
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
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...