ISPE: A Catalyst for Change

Founded in 1980

Not-for-profit, non-lobbyingglobal professional society

25,000 individual Members from 90 countries

Provides technological knowledge, education, and guidance documents for pharmaceutical industry

Provides forums for exchange among industry, suppliers, academia, and regulators

Strong ties with regulatory authorities worldwide

Who Are ISPE’s Members?ISPE connects pharmaceutical professionals globally from development through delivery.ISPE Members represent the full circle of knowledge required for innovation: • Industry professionals from companies that manufacture

Pharmaceuticals, Biopharmaceuticals, APIs, Veterinary Medicine, Generics, Medical Devices and Diagnostics

• Service Providers and Suppliers of Equipment

• Regulatory Authority Leaders

• Academics and Students

ISPE Members Work in…

ISPE Membership Expertise• Architect / Engineer /

Construction• Clinical / Investigational

Materials• Health / Safety / Environmental• Information Technology• Logistics/Supply Chain

Management• Maintenance• Operations / Manufacturing• Process Control/Automation• Process Development /

Technology Transfer

• Project Management• Quality Assurance/Control• Regulatory/Compliance• Research and Development• Sales / Marketing /

Business Development• Technical Services /

Product Support• Training• Validation / Qualification /

Commissioning

ISPE Membership is Global

How does ISPE Assist its Members?

• Provides access to regulatory and industry news, information, and resources

• Provides practical application education and training needed to “get the job done” today, while equipping you with the skills and knowledge needed for tomorrow’s challenges

• Provides global and local networking opportunities through Communities of Practice and Affiliates and Chapters that foster collaboration and sharing

What Does ISPE Provide to Members?Networking Opportunities• Communities of Practice • Local Affiliates/Chapters• Member Directory on-line 24/7• Global On-line Career

Exchange

Professional Growth• Education and Training• Certified Pharmaceutical

Industry Professional (CPIP™) credential

• On-line learning

Critical Information• ISPE’s Body of Knowledge• Global Resources through the

Society’s Web site at www.ISPE.org

• Pharmaceutical Engineering magazine

• Peer-reviewed Journal of Pharmaceutical Innovation

• Technical Documents

Communities of Practice (COPs)Purpose• Provides forum for community

members to help each other solve everyday work problems

• Develops and disseminates best practices, guidelines, and procedures, and creates breakthrough ideas, knowledge, and practices

• Organizes, manages, and researches a Body of Knowledge from which community members can draw

•Connecting members person-to-person•Collecting relevant information to share

Communities of Practice (COPs)Current COPs:• Active Pharmaceutical Ingredients (API)• Biotechnology • Commissioning and Qualification • Containment • Critical Utilities• Disposables • Good Automated Manufacturing Practice (GAMP®)• Heating, Ventilation, and Air Conditioning (HVAC)• Investigational Products • Packaging• Process Analytical Technology• Process/Product Development• Project Management • Sterile Products Processing

Emerging Economy Members

• Industry professionals from countries the World Bank classifies as “Emerging Economies”

• Membership Dues: $30/ €30 year

• Full Society benefits with electronic access to publications

Student Members

• Special resources and events to help develop your career

• Networking opportunities with top professionals in your field tofine-tune skills and develop interviewing practices

• More than 40 Student Chapters supported by local ISPE Affiliates and Chapters at colleges and universities worldwide

• Membership Dues: $15/ €15 per year ($5/ €5 per year for Emerging Economy countries)

International Student Members

AustraliaAustriaBelgiumCanadaChinaCzech RepublicDominican RepublicFinlandFranceGermanyIndiaIndonesiaIreland

ItalyJordanKoreaMalaysiaMexicoPolandSingaporeSwedenSwitzerlandTaiwanTurkeyUnited KingdomUnited States

Student Members represent the following countries:

How is ISPE Global and Local?

• 90% of ISPE Members belong to an Affiliate or Chapter

• ISPE Members take global issues and determine local solutions…in the local language

• Affiliate/Chapter events provide a forum for transfer of industry/regulatory information and technology on a local basis and access to:• Educational seminar/training programs• Industry/regulatory/academia/professional networking• Facility tours

• Affiliate/Chapter Web sites deal with regional topics in local language

Affiliates/Chapters: Asia Pacific

Asia Pacific Affiliates• Australasia

• Brisbane Chapter• Melbourne Chapter• New Zealand Chapter• Sydney Chapter

• India• Japan• Singapore• Thailand

In Development• China• Indonesia

Affiliates/Chapters: EuropeEuropean Affiliates

• Belgium• Czech Republic/

Slovakia• France• Germany/Austria/

Switzerland• Ireland• Italy• Nordic• Poland

• Spain • The Netherlands• Turkey• United Kingdom

• Central Region• Northeast Region• Northwest Region• Scotland Region• Southern Region

Affiliates/Chapters: North/South America

North American Affiliates• Canada Affiliate

• Central Canada Chapter• United States Affiliate

• Boston Area• Carolina-South Atlantic• Chesapeake Bay Area• Delaware Valley• Great Lakes• Greater Los Angeles Area• Midwest

• New England• New Jersey • Pacific Northwest• Puerto Rico• Rocky Mountain• San Diego • San Francisco/Bay Area• South Central

South American Affiliates • Argentina Affiliate • Brazil Affiliate

ISPE Web siteYour 24/7 Access Point to Knowledge

www.ISPE.org

• On-line Membership Directory

• Pharmaceutical Engineeringmagazine articles: search and download

• Journal of Pharmaceutical Innovation articles: search and download

• Technical Glossary of Pharmaceutical Terms

• Communities of Practice

• Global Supplier’s Directory

• Regulatory News

• Reference Documents

• Global Events Calendar

• Global Career Exchange

ISPE Professional CertificationThe Certified Pharmaceutical Industry Professional (CPIPSM)

• An international competency-based credential• Eligibility requirements (Bachelor's degree + demonstrated

industry experience)• Written examination

Value for the professional:• Enhanced career mobility• Competitive edge

Value for the employer:• Global competency standard• Recruiting tool

Conferred by the ISPE Professional Certification Commission

ISPE’s Technical Contribution to the Industry

• Baseline® Pharmaceutical Engineering Guides• Good Automated Manufacturing Practice (GAMP®) • ISPE Good Practice Guides • Providing technical input to regulatory authorities

such as US FDA, EMEA, JMHLW, WHO, and PIC/S

The ISPE logo, tagline, GAMP, and Baseline are registered trademarks of ISPE.

Baseline® Pharmaceutical Engineering Guides

Currently Available• Active Pharmaceutical

Ingredients, a revision of Bulk Pharmaceutical Chemicals

• Oral Solid Dosage Forms• Sterile Manufacturing

Facilities• Water and Steam Systems• Commissioning and

Qualification• Biopharmaceutical

Manufacturing Facilities

Upcoming Guides• Packaging, Labeling, and

Warehousing Operations(2007)

• Maintenance (2008)• Laboratories (2008)

ISPE Industry Guidance• GAMP® 4, Good Automated Manufacturing Practice Guide for

Validation of Automated Systems• GAMP® 5, Good Automated Manufacturing Practice Guide for

Validation of Automated Systems - 1st quarter 2008

• Currently Available GAMP® Good Practice Guides• Calibration Management• Validation of Process Control Systems• A Risk-Based Approach to Compliant Electronic Records and

Signatures• Validation of Laboratory Computerized Systems• IT Infrastructure Control and Compliance• Global Information Systems Control and Compliance• Testing of GxP Systems• Electronic Data Archiving

ISPE Industry GuidanceISPE Good Practice Guides Currently Available

• Comprehensive Guide to Clinical Materials• ISPE Good Practice Guide: Technology Transfer• ISPE Good Practice Guide: Assessing the Particulate Containment

Performance of Pharmaceutical Equipment• Commissioning and Qualification of Pharmaceutical Water and Steam

Systems• Biologics for Clinical Materials Professionals

Technical Documents Under Development• Baseline Guide: Risk Based Manufacture of Active Pharmaceutical Products

(Risk–MaPP) • Baseline Guide: Biopharmaceutical Process Development and Manufacturing • ISPE Good Practice Guide: Good Engineering Practice• ISPE Good Practice Guide: HVAC• ISPE Good Practice Guide: Pharmaceutical Testing Laboratories• ISPE Good Practice Guide: Science and Risk-Based Cleaning Process

Development and Validation

Facility of the Year Awards (FOYA)• Competition recognizing state-of-the-art

pharmaceutical manufacturing projects that utilize new / innovative technologies to improve quality and reduce costs

• Program provides a platform to showcase new products and accomplishments, and share of development of new applications in the areas of:

• Process Innovation• Project Execution• Equipment/Innovation• Facility/Integration• Energy Efficiency• Operational Excellence

Contact ISPEISPE Headquarters3109 W. Dr. M L King Jr. Blvd., St 250, Tampa, Florida 33607 USATel: +1-813-960-2105 Fax: +1-813-264-2816E-mail: [email protected]

European OfficeAvenue de Tervueren, 300, B-1150, Brussels, BelgiumTel: +32-2-743-44-22 Fax: +32-2-743-15-50E-mail: [email protected]

Asia Pacific Office73 Bukit Timah Road, #03-01 Rex House, Singapore 229832Tel: +65 6496 5502 Fax: +65 6336 2263E-mail: [email protected]

Visit www.ISPE.org for more information