Step 1. Is this the right certification for you?
Here are the minimum expectations, requirements, experience and exam specifics for a Pharmaceutical GMP Professional Certification.
Education and/or 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.
You 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.
There are no education waivers for this exam.
Minimum Expectations for 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 US, 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.
Each certification candidate is required to pass a written examination that consists of multiple-choice questions that measure comprehension of the Body of Knowledge. The Pharmaceutical GMP Professional examination is a one-part, 165-question*, four and a half hour exam.
*All CBT delivered certification exams include unscored items in addition to BoK classified items. For more information please click here
Examinations are conducted throughout the year and are delivered via computer based testing (CBT) through ASQ's testing partner Prometric. 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 FAQ.
Please Note: The Body of Knowledge for certification is affected by new technologies, policies, and the changing dynamics of manufacturing and service industries. Changed versions of the examination based on the current Body of Knowledge are used at each offering.
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