Guidance Documents

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

iSpeak Blog
The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for...
Guidance Documents
09 September 2021
News & Press Releases
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...
Guidance Docs
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...
Guidance Docs
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:
Guidance Documents
21 May 2021
News & Press Releases
ISPE announced the release of its latest Guide, ISPE 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...
Guidance Documents
11 February 2021
News & Press Releases
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Maintenance, 2nd Edition. The Guide describes current established good practices and seeks to provide a practical and consistent interpretation of the required elements of a...
Guidance Docs
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.
Guidance Documents
22 January 2021
News & Press Releases
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Equipment Reliability. This Guide offers best practices with respect to equipment reliability, addresses specific opportunities for the pharmaceutical industry beyond the...
Guidance Documents
15 December 2020
News & Press Releases
ISPE announced the release of its latest Guide, ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System. This is the first in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable...