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