Communities of Practice (COPs) Descriptions

Active Pharmaceutical Ingredients (API)
The API COP proactively advocates the importance of API in the drug product delivery process with the objectives of providing a forum for members to discuss issues of common interest through: education and training; Listserv E-Discussions; regulatory cooperation; information dissemination; establishment of links to internal and external groups with common interests.

Biotechnology (Biotech)
The Biotech COP aims to create a global focal point of support for Pharmaceutical Professionals operating in the Biotech Sector. Support means the creating and delivery of training, technical materials and information, and providing opportunities for collaboration and networking.

Commissioning and Qualification (C&Q)
The C&Q COP aims to align the processes of commissioning and qualification with a science and risk based approach, provide input and guidance into other documents, and to facilitate understanding and organizational change necessary to implement this approach. This will be accomplished through: discussion and communications forums; education and training; guidelines and standards review; and facilitating links to other groups with common interests.

Containment
The Containment COP provides a forum for all those involved in the Safety of Patients and People from exposure, contamination and cross contamination of hazardous compounds and interact with all appropriate stakeholders to share, influence and change knowledge, guidance and regulation for the good of all.

Critical Utilities (CU)
The Critical Utilities COP provides a discussion forum and network for Critical Utilities professionals by encourage the sharing of ideas relevant to topics such as system design, commissioning & qualification, process validation, requalification, regulations, operations, and maintenance.

Disposables
The Disposables COP mission aims to create a global focal point of support for biopharmaceutical professionals working with single-use disposable technologies. Single-use technologies includes bags systems, filters, connectors, aseptic transfer, controlled freeze-thaw, tubing and any other equipment for bioprocessing developed in single-use format.

Good Automated Manufacturing Practice (GAMP)
The GAMP Forum exists to promote the understanding of the regulation and use of automated systems within healthcare industries.

Good Control Laboratory Practices (GCLP)
The mission of the Good Control Laboratory Practices Community of Practice (GCLP COP) is to: • Provide a forum for members to discuss issues of common interest in the area of GCLP with the primary objective being to find solutions to common industry problems • Pro-actively advocate the importance of GCLP amongst members and pharmaceutical industry professionals • Share best practices in the area of GCLP amongst ISPE members and constituents • Create a vast body of knowledge in the area of GCLP that is easily accessible by ISPE’s GCLP COP Members

Heating, Ventilation, and Air Conditioning (HVAC)
The ISPE HVAC Community of Practice is the premier global organization that serves as a one-stop shopping outlet and provides relevant, timely information and solutions to real-world problems related to HVAC for pharmaceutical facilities.

Investigational Products (IP)
The Clinical Materials (CM) and Investigational Medicinal Products (IMP) Communities of Practice (COP) are pleased to announce the formation of a new global COP: Investigational Products. The Investigational Products COP is a result of the consolidation of the CM (US-based) and IMP (EU-based) organizations into one global organization. As a result of this globalization effort, there will be one global council governing the COP with regional steering committees representing North America and Europe.

Packaging
The Packaging COP will focus on the creation of a community for pharmaceutical industry professionals working in the area of packaging from the facility to the packaging equipment, and includes labeling, warehousing, components, and equipment.

Process Analytical Technology (PAT)  
The PAT COP creates a global focal point of support and a discussion forum for Pharmaceutical Professionals interested in Process Analytical Technology. This means the creation and delivery of training, technical materials and information, as well as providing opportunities for collaboration and networking.

Process/Product Development (PPD)
The PPD COP is a dynamic forum for professionals in product/process development to discuss and address issues of common interest.

Project Management (PM)
The Project Management COP is a dynamic forum for professionals working within the Pharma Industry who have an active interest in promoting "continuous improvement" project management by creating a body of knowledge specific to the professionals needs of its members.

Sterile Products Processing (SPP)
The SPP COP aims to establish and manage a forum that supports all facets of sterile products processing; enables common interest discussions; provides access to relevant information and supports member networking.

Sustainable Facilities
Sustainable Facilities COP aims to respond, on behalf of the Pharmaceutical sector, to the global issue of environmental sustainability for facilities & infrastructures (e.g demand for reduced carbon emissions & other green house gases, energy usage, and green buiding design/construction/ operation). SUS COP aims to provide technical and practical knowledge bases and forums to share, support and encourage best practice in the design, delivery and operation of efficient and sustainable pharmaceutical facilities and infrastructures. Including the development, capture and sharing of energy benchmarking data, which will enable energy labelling and comparison of complex facilities, in an effort to drive continuous improvement.