Guidance Documents

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

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ISPE Good Practice Guide: Maintenance 2nd Edition

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Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support. The ISPE Good...
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ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

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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...
How Knowledge Management Can Improve Quality and Increase Efficiency
iSpeak Blog
How Knowledge Management Can Improve Quality and Increase Efficiency

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...

ISPE Publishes ISPE GAMP® Good Practice Guide: Enabling Innovation
Press Releases

ISPE Publishes ISPE GAMP® Good Practice Guide: Enabling Innovation

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...
ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices
Press Releases

ISPE Publishes ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices

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...
Good Practice Guides

Good Practice Guide: IMP Reverse Logistics

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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Cleaning Validation Lifecycle - Applications, Methods, and Controls

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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...
ISPE APQ Guide: Management Responsibilities & Review (MRR) Cover
Press Releases

ISPE Publishes ISPE APQ Guide: Management Responsibilities & Review (MRR)

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...
APQ

APQ Guide: Management Responsibilities & Review (MRR)

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: