PEGP Exam study guide
PEGP Exam · Work through your exam, one topic at a time.
The PEGP - Pharmaceutical Engineering Graduate Program Exam - is a knowledge assessment for engineers, scientists, and graduate-level candidates moving into pharmaceutical manufacturing and process roles. It tests whether you can reason across the full lifecycle of a drug product: how unit operations behave, how processes are scaled and transferred, how quality is built in rather than tested in, and how GMP, validation, and safety obligations shape everyday engineering decisions. The PEGP Exam study guide has 7 sections and about 2,763 words.
01Pharmaceutical Engineering Fundamentals
Pharmaceutical Engineering Fundamentals covers the physical and mathematical base for every later domain: mass and energy balances, fluid flow, heat transfer, thermodynamics, reaction kinetics, and materials of construction. The exam favors problems where the engineering principle is simple but the pharmaceutical context changes the assumptions-for example, non-Newtonian excipient slurries, clean-steam service, or a heat exchanger that must be cleanable in place.
431 words, about 2 min02Process Development and Scale-Up
Process Development and Scale-Up tests whether you can move a process from bench to pilot to commercial without losing product quality. The exam emphasizes Quality by Design (QbD): linking material attributes and process parameters to critical quality attributes (CQAs), defining a design space under ICH Q8, and justifying scale-up rules rather than copying them.
393 words, about 2 min03Unit Operations and Equipment Design
Unit Operations and Equipment Design tests selection, sizing, and specification of the equipment that actually makes the product: reactors, centrifuges, filters, dryers, mills, blenders, chromatographs, and clean-in-place systems. Questions often combine a simple sizing calculation with a cleanability or materials constraint.
400 words, about 2 min04Quality Assurance and Regulatory Compliance
Quality Assurance and Regulatory Compliance tests the systems that keep product release defensible: GMP regulations, ICH guidance, deviation and CAPA management, change control, batch record review, and data integrity. The exam rewards knowing which requirement is mandatory and which is guidance, and how to write an investigation that stands up to inspection.
363 words, about 2 min05Good Manufacturing Practice (GMP)
Good Manufacturing Practice tests the operational controls that prevent contamination, mix-ups, and cross-contamination: facility classification, HVAC, personnel and material flows, cleaning, aseptic technique, and documentation on the floor. EU GMP Annex 1 and FDA aseptic guidance are key references for sterile operations.
418 words, about 2 min06Validation and Qualification
Validation and Qualification tests the evidence that a facility, utility, equipment, or process consistently does what it claims. The exam distinguishes qualification of equipment from validation of processes, and expects a risk-based, lifecycle approach rather than a one-time documentation exercise.
366 words, about 2 min07Safety, Health, and Environmental Management
Safety, Health, and Environmental Management tests hazard identification and control in pharmaceutical operations: reactive chemistry, flammable solvents, dust explosions, pressure systems, containment of potent compounds, and waste. The exam expects you to recognize when a process safety management (PSM) program is triggered and to select controls in the right order.
392 words, about 2 min