ISPE Rocky Mountain Chapter Members
Rocky Mountain Chapter

Guidance Documents

  • Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

    Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

    Published
    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

    GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

    Published
    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.
  • 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.

ISPE Blog

Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare...