ISPE Communities of Practice (COPs)

ISPE implemented Communities of Practice (COPs) recognizing the challenge of the pharmaceutical industry to achieve continuous improvement. COPs are groups of people that share a concern or a passion about a topic, and who deepen their knowledge and expertise by interacting on an ongoing basis. ISPEs COPs enable colleagues in specific disciplines to rapidly exchange information and solutions to everyday problems by virtue of the COP websites and online community discussions. Through professional networking and peer collaboration, ISPE COPs produce discipline-specific content that expands members knowledge and expertise, increases quality, and strives for continuous advancement in the industry.

Containment COP Membership Has Its Professional Benefits:

You can access and participate in the development of Containment best practices by joining the Containment COP. The Containment COP is supporting and maintaining local COPs in Germany/Austria/Switzerland, India, and Japan. The COP has also been instrumental in providing assistance in developing several very important ISPE guidance documents. Other valuable membership benefits derived from this COP include:

Provision of a dedicated community of like-minded Containment professionals providing networking opportunities and access to real world solutions

Inclusion in an environment in which technical documents of significance are created by and for Containment COP members

Opportunities to become actively involved and help determine the focus of the Containment COP

Access to training and conferences on containment related topics

Containment Guidance The Containment of potent compounds remains one of the highest profile requirements to our industry. The Containment COP Steering Committee facilitates the development of a Containment specific Body of Knowledge by:

Determining what the needs and hot topics of the industry are

Reviewing forthcoming standards and guides and determining how they may alter Containment guidance documents

Supporting the development of technical documents: Risk-MaPP Cleaning Containment Systems

The Containment COP produces Knowledge Briefs, webinars, and educational programs to benefit its members and to share relevant information related to Containment issues.

To Become a Member of this Exciting COP and to Begin Participating Immediately 1. Go to www.ispe.org/ContainmentCOP. 2. Click on the Discussions tab, or any other content tabs of interest. Note you must be a Containment COP member and log in to participate in the discussions. 3. To join the Containment COP go to www.ispe.org/cops and click Join a COP. 4. Then, scroll down to the Containment COP and place a check mark in the box. 5. Click the Join button at the very end of the page to confirm your membership in the Containment COP.

Membership in ISPEs Containment COP is complimentary for ISPE Members. Join today to access discussions, tools, and all resources offered by ISPE COPs.

www.ispe.org/ContainmentCOP

Development of the Containment COP The Containment COP was formed in 2005, after ISPE formally recognized the importance of Communities of Practice (COPs). The intent of forming the COP was to influence regulators and professionals worldwide in the field of Containment and to advance quality, cost, safety issues, and best practices. The Containment COP attempts to attract industry leaders who recognize that Containment provides the best vehicle to have an impact on the industry through the creation and dissemination of information. The Containment COP quickly became involved in some of ISPEs most important initiatives, such as contributing as part of the document task team for the publication of the Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide and the development of the Assessing the Particulate Containment Performance of Pharmaceutical Equipment Revision guidance document.

Mission of the Containment COP The Containment COP provides a forum for those individuals involved in enhancing the safety of patients and people from exposure, contamination and cross contamination of hazardous compounds. The Containment COP facilitates interaction with all appropriate stakeholders to share, influence and change knowledge, guidance and regulations for the good of all. The Containment COP will seek to become a World Class knowledgeable panel representing the thoughts of subject matter experts selected by consensus of a steering committee.

Ways to Get Involved with the Containment Community of Practice The Containment COP has more than 2,200 members representing professionals in the areas of engineering, environmental health and safety, occupational toxicology, operations, designers, and other engineer personnel from the A&E, contractors, quality, regulatory, and validation sectors. Vendors who provide containment systems, integration, and processing are also an important component of the community. There are many ways for COP members to contribute to and learn from the Containment community and Body of Knowledge. By visiting the Containment COP website members can:

Access Community Discussions monitored by Containment COP Steering Committee members to ask questions, share expertise, and find solutions to company and industry-related problems.

Read technical articles in the most recent editions of the Containment COP E-Letters.

Download presentations, articles, and other relevant documents.

Search for Containment COP members by name, company, Affiliate or Chapter, country, etc.

Easily and conveniently access Containment guidance documents, articles, and other valuable resources.

With so many ways to connect with CONTAINMENT COP members and access valuable technical knowledge, there is no reason not to get involved. Visit www.ispe.org/ContainmentCOP today and begin participating in your Community of Practice!

www.ispe.org/ContainmentCOP

How the Containment COP Benefits Members and the Industry The Containment COP is a dynamic forum of professionals working with potent pharmaceutical compounds requiring containment who are seeking relevant and timely information to discuss and address issues of common interest. The Containment COP provides a discussion and information sharing forum for containment issues, and is a technical body associated with Risk-MaPP and Assessing the Particulate Containment Performance of Pharmaceutical Equipment.

Risk-MaPP: What Is It and Why You Need It The science of toxicology recognizes the principles of a continuum of hazard associated with all compounds, even within individual classes of compounds. The Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, this document developed under the collaborative effort of the Containment COP and the Risk-MaPP Task Team is an essential tool for Containment professionals.

Assessing the Particulate Containment Performance of Pharmaceutical Equipment Revision The Containment COP is directing ISPEs editorial team with the revision of the Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment. This document will identify test methods applied to powders, airborne, and surface contamination. Methods shared through this Good Practice Guide are useful to conduct testing activities including Design Verification Testing (DVT), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) to provide data to evaluate the effectiveness of various containment technologies.