Certified Pharmaceutical Industry Professional Credential™ (CPIP™) - Examination

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) number to the candidate. The ATT number will allow the candidate to register a date and time with a Prometric Test Center .

The examination (closed book) is based on all of the following 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 closed book 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

• CPIP Examination Application Forms
• CPIP Practice Exam

Examination Application Fees

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

Test Dates and Locations