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Certification Examination

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CPIP candidates deemed eligible by the ISPE-PCC must submit a CPIP examination application form and payment. After payment is validated, the ISPE-PCC will issue an authorization to test (ATT) letter to the candidate. The ATT number will allow the candidate to register a date and time with a Prometric Test Center. You must schedule and take your examination before the earliest of either the “Valid To” date on your ATT Letter or 31 May 2014 which is the date that the examination will be retired and no longer available.

The examination (closed book) is based on seven knowledge elements:

  • Product Development

    Overview: Through the interactions of multi-disciplinary functions and the scientific application of experimental design methodologies, implement a process to reproducibly and economically manufacture a product of (a) the desired formulation, dosage form, and specifications that meets predicted quality; (b) is optimized for purity, potency, and efficacy; and (c) facilitates continuous improvement.

    • A. Formulation, clinical phases, and manufacture
    • B. Technology transfer
    • C. Production scale-up and optimization
  • Facilities and Equipment

    Overview: Knowledge required to ensure: (a) that the critical physical and chemical requirements of drug products are properly understood and managed; and (b) that the selection of process equipment and the design of facilities and support utility systems will consistently deliver those requirements and all other aspects of the product specification (including quantity and timely delivery)

    • A. Design and construction/installation
    • B. Commissioning and qualification as a risk management strategy
    • C. Operation and maintenance
    • D. Controls and automation
  • Information Systems

    Overview: Knowledge of (a) the types of information and data management systems that are integral to successful drug development, manufacturing, and distribution; and (b) the controls and methods necessary to maintain data integrity and security.

  • Supply Chain Management

    Overview: Knowledge of (a) the key components of the supply and distribution chains and their financial impact; (b) the systems required for dynamically controlling and automating receipt, storage and dispensing of raw materials, and packaging materials; and (c) storage and distribution of finished products, so that the integrity of the product is not impaired by any of these processes.

    • A. Materials management
    • B. Operational economics
    • C. Warehouse and distribution management
  • Production Systems

    Overview: Knowledge of (a) the full range and scope of unit operations and production steps for manufacturing APIs and both small molecule and biologic pharmaceuticals; (b) the building and critical process utility systems that support the manufacturing process; and (c) the means of managing and dynamically controlling and automating manufacturing and warehousing operations.

    • A. Production unit operations - drug (small molecule) and biologics
    • B. Production management
    • C. Production Control
  • Regulatory Compliance (includes drugs, environmental, health and safety)

    Overview: A fundamental understanding of (a) international regulations and guidance issued by regulatory bodies and coalitions which shape the world’s current pharmaceutical-related requirements and future directions, and (b) the application of regulations and industry-generated guidance for global harmonization of compliance and product registration.

    • A. Government regulations
    • B. Standards, practices, and guides
  • Quality Systems

    Overview: Knowledge of the role and elements of a quality management system and its impact within the overall risk management approach, as well as its implementation in a scientific and pragmatic manner.

    • A. Risk management and Quality Management System (QMS)
    • B. Systems validation (changed from Validated Controls)

The computer-based exam (150 multiple choice questions) is taken by reservation at a Prometric test center. Detailed information pertaining to the exam is located in the CPIP Eligibility Application Handbook.

A CPIP Study Guide is available to assist candidates in preparing for the examination.

Documents for Download

Examination Application Fees

ISPE Member: US$350, €259
ISPE Nonmember: US$460, €341

Test Dates and Locations 

CPIP EXAMINATION SCHEDULE
LOCATE A TEST SITE

October 1, 2013 to May 31, 2014

www.prometric.com/ISPE/default.htm

  • Click "START"
  • Enter "Country" and "State"
  • Click "Locate a test site"
 

Sam DeMarco, CPIP, President Compliance Team Inc, United States

"I believe that the credential has made me more confident and I feel that my clients engage me in more philosophical discussions on pharmaceutical industry subject matter. I get the sense that my clients 'listen' to me in a more serious 'in tune' way."

Marc Fleischman, CPIP, Facility and Verification Engineer, Genzyme, a Sanofi Company

"I chose to pursue the CPIP certification as a way to learn new phases of the industry and to codify my existing knowledge. As I prepared and studied for the exam, I was challenged to develop a broader understanding of many industry concepts that I had not been routinely exposed to. The experience has left me with a deep understanding of GMP regulation and broad industry knowledge across the entire bio/pharm lifecycle."