ISPE Nordic Affiliate Members
Nordic Affiliate

Guidance Documents

  • Good Practice Guide: Process Validation

    Good Practice Guide: Process Validation

    Published
    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

    Good Practice Guide: Technology Transfer 3rd Edition

    Published
    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.
  • Good Practice Guide: Single-Use Technology

    Good Practice Guide: Single-Use Technology

    Published
    Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.
  • GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

    GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

    Published
    The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization. In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process...