Pharmaceutical GMP Professional Certification CPGP

Here are the minimum expectations, requirements, experience and exam specifics for a Certified Pharmaceutical GMP Professional.

Work Experience

Work experience must be in a full time, paid role. Paid intern, co-op or any other course work cannot be applied towards the work experience requirement.

Candidates must have five years of on-the-job experience in one or more of the areas of the Certified Pharmaceutical GMP Professional Body of Knowledge. A minimum of three years of this experience must be in a decision-making position. "Decision-making" is defined as the authority to define, execute, or control projects/processes and to be responsible for the outcome. This may or may not include management or supervisory positions.

Education

There are no education waivers for this exam.

Expectations

Here are the minimum expectations of a Certified Pharmaceutical GMP Professional.

• Will have a fundamental understanding of regulatory agency governance including, global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.
• Will be able to develop and apply elements and requirements of a quality system, evaluate various types of audits and self-inspections, and analyze documents and record management systems.
• Will be able to distinguish between and verify suitability of factors relating to laboratory systems, including relevant compendia for U.S., Europe and Japan, investigations of aberrant laboratory results, and instrument control and record-keeping.
• Will be able to determine requirements and specifications for construction of facilities, utilities and equipment, evaluate automated or computerized systems, and apply business continuity plans and disaster recovery techniques.
• Will be able to use sampling plans and apply procedures for shipping and receiving materials, analyze in-house storage, identification, and rotation of materials, and meet requirements for materials traceability and sourcing, including returned goods.
• Will have a thorough understanding of sterile and nonsterile manufacturing systems and be able to analyze master and completed batch records, material control procedures, and contamination controls.
• Will have a thorough understanding of product design factors and phase-appropriate GMP requirements. Will be able to develop and evaluate filling and packaging operations and controls, and analyze technology transfer activities.

Review a list of references that provide the basis for the exam questions. These items give you a better idea of the material covered in the exam.

Training

• The Certified Pharmaceutical GMP Professional Question Bank

Need other training options? ASQ Sections and ASQ Forums/Divisions offer more training opportunities.

Books

• The Certified Pharmaceutical GMP Professional Handbook, Second Edition
• The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals
• Handbook of Investigation and Effective CAPA Systems, Second Edition
• Quality Risk Management in the FDA-Regulated Industry, Second Edition
• Statistical Process Control for the FDA-Regulated Industry
• Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition
• Search for more ASQ books

Examination

Each certification candidate is required to pass an examination that consists of multiple-choice questions that measure comprehension of the Body of Knowledge.

Computer Delivered - The CPGP examination is a one-part, 165- multiple choice question exam, and is offered in English only. 150 multiple choice questions are scored and 15 are unscored. Total appointment time is four-and-a-half-hours, exam time is 4 hours and 18 minutes.

Paper and Pencil - The CPGP examination is a one-part, 150- multiple choice question, four-hour exam and is offered in English only.

All examinations are open book. Each participant must bring his or her own reference materials. Use of reference materials and calculators is explained in the FAQs.