Pharmaceutical GMP Professional Certification CPGP
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The Certified Pharmaceutical GMP Professional understands the good manufacturing practices (GMP) as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologics, ectoparasiticides, and dietary supplements (alternatively called nutraceuticals) where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations.
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Here are the minimum expectations, requirements, experience and exam specifics for a Certified Pharmaceutical GMP Professional.
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.
There are no education waivers for this exam.
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.
Body of Knowledge
This BOK includes subtext explanations and corresponding cognitive levels for each topic or subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content that can be tested.
The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam but is intended to clarify how topics relate to the role of the Certified Pharmaceutical GMP Professional (CPGP). The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more complete description of cognitive levels is provided at the end of this document.
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.
Download the Certified Pharmaceutical GMP Professional Body of Knowledge