Member Services
Knowledge Briefs
In effort to address the industry’s need for current, relevant, and useful content, ISPE has developed concise, summary documents called Knowledge Briefs. These tools are easy-to-read resources that help industry professionals get up-to-speed quickly on contemporary pharmaceutical industry topics.
Knowledge Briefs are intended to provide an overview of a discipline-specific subject. Knowledge Briefs are presented in several levels ranging from Basic to Advanced. The context and relevance of the subject can be easily understood and applied to day-to-day job functions. Each brief includes links to additional ISPE resources such as technical documents, Pharmaceutical Engineering articles, Communities of Practice, and educational seminars to provide more specific and detailed information on the subject.
Knowledge Briefs are available for immediate download.
Price: free to ISPE Members, $5 US / €3 to nonmembers.
Removal of “Use by Dates” from Clinical Trial Material Labels in the European Union 
by Michael A. Arnold
Level: Intermediate
This Knowledge Brief explains how – through a risk analysis – IVR/IWR technology may be a better alternative to the conventional method of managing “use by dates.” Guidance is also provided on how to notify authorities of an intent to use IVR/IWR technology.
Members: Download now 
Nonmembers: purchase from the ISPE Online Store
Dry Powder Sampling and the Containment of Hazardous Compounds
By Jonathan Lind
Level: Intermediate
This Knowledge Brief provides a high level review of the requirements for the successful containment of hazardous compounds associated with dry powder sampling activities.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Overview: Regulatory Framework - US FDA
By Dr. Kate McCormick
Level: Fundamental
This Knowledge Brief provides a basic overview of the US FDA's organizational structure and licensing procedures relevant to pharmaceutical manufacturing and regulation.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Overview: Regulatory Framework - EMEA
By Dr. Kate McCormick
Level: Fundamental
This Knowledge Brief provides a basic overview of the EMEA's organizational structure, responsibilities, and regulations relevant to the manufacture of medicinal products.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Overview: Regulatory Framework - PIC/S and ICH
By Dr. Kate McCormick Level: Fundamental
This Knowledge Brief provides a basic overview of the establishment and purpose of these two organizations and PIC/S and ICH publications pertinent to the pharmaceutical manufacturer.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Packaging Equipment: Slat Fillers
By James Hills
Level: Fundamental
This Knowledge Brief provides a basic overview of the general concept and design of the slat filler and addresses several considerations important to achieving maximum operational efficiency.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Reducing the Cost of Manufacturing
By John Nichols
Level: Fundamental
This Knowledge Brief provides an overview of how Targeted Processes, Process Intensification, and Lean/Continuous Manufacturing will serve as key techniques and technologies to reduce the cost of pharmaceutical manufacturing today and in the future.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Biotechnology Basics
Adapted from the ISPE Training Course on Biotech Basics
Level: Basic
This Knowledge Brief provides basic concepts explaining the science of biotechnology and how science and process are combined to lead to the manufacture of a human therapeutic product.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Commissioning and Qualification of Biopharmaceutical Facilities
The information contained in this Knowledge Brief was extracted from the ISPE Baseline Guide®: Biopharmaceutical Facilities, authored by the Biopharmaceutical Manufacturing Facilities Baseline Guide® Task Team
Level: Intermediate
This Knowledge Brief summarizes the considerations involved in the commissioning and qualification of a biopharmaceutical manufacturing facility.
Members: Download now 
Nonmembers: purchase from the ISPE Online Store
Quality by Design
by John Berridge, PhD
Level: Intermediate
This Knowledge Brief provides and explains the basic elements of Quality by Design (QbD).
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Risk-Based Approaches to Cross Contamination
Level: Intermediate
The concepts presented in this Knowledge Brief were developed from the ISPE Baseline® Guide, the Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) – A Guide to Managing Risks Associated with Cross Contamination, which is currently being reviewed by the US FDA and will be available from ISPE in 2009.
Members: Download now
Nonmembers: purchase from the ISPE Online Store
Have a Great Idea for a Knowledge Brief?
Knowledge Briefs are developed from a wide variety of resources including ISPE training courses, conferences, seminars, technical documents, individual authors who are subject matter experts, as well as expert interchanges within the Society’s Communities of Practice.
Read details on how to develop and submit a Knowledge Brief for publication by ISPE.
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