Guidance Documents

Information about ISPE's Guidance Documents, white papers, Knowledge Briefs and other written technical guidance.

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In 2008, ICH Q10 identified Knowledge Management (KM) and Quality Risk Management (QRM) as the enablers of an effective Pharmaceutical Quality System (PQS). Since then, the pharmaceutical industry has been slow in...
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ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical industry has made significant progress in adopting QRM into systems and processes. However, the...

News & Press Releases
05 October 2021
ISPE announced the release of its latest Guide, ISPE GAMP® Good Practice Guide: Enabling Innovation–Critical Thinking, Agile, IT Service Management . The drive within life sciences to improve patient safety and product quality, and provide value to...
News & Press Releases
09 September 2021
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices . The Guide is the first collection of best practices for the management of...
Every year the number of clinical trials conducted across the globe rises in a concerted effort to develop new or improved medicinal products that ultimately improve lives. The pharmaceutical industry has developed standards and best practices in almost every aspect of a trial. There is, however, one area that lacks foundational best practices: that of medicinal product accountability, reconciliation, and return for destruction, otherwise known as reverse logistics.
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Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carry over, and cross-contamination is controlled...
News & Press Releases
04 August 2021
ISPE announced the release of its latest Guide, ISPE APQ Guide: Management Responsibilities and Management Review . This is the second publication in the APQ Guide series that seeks to improve the state of pharmaceutical quality and ensure...
ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 as well as other key leadership components:
News & Press Releases
21 May 2021
ISPE announced the release of its latest Guide, I SPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry . The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS). The...