The International Society for Pharmaceutical Engineering (ISPE) has release their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation, providing professional insights for fundamental principles, process lifecycle approaches, and changes in validation practices. 

“Patient requirements and product attributes represent the initiative of new approaches within process validation and ISPE’s guide supports current developments,” said Robert Beall, PMP, director, Product Lifecycle Management, ProPharma Group and Guide Co-Lead. “The guide is a technical and scientific advisory resource to help organizations understand process validation through carefully constructed theories to establish defendable processes in addition to offering assistance with global regulatory requirements.”

The guide addresses: 

• The different terminology used by regulators and the similarities in underlying fundamental principles 
• Practical implementation advice, including how each of the three validation stages may be implemented and how the stages are linked
• About statistical rationale and information that may be applied at different stages of the lifecycle 
• How to maintain a state of control throughout the product lifecycle