PEGP Exam study plan

Define and contrast the core pharmaceutical engineering quantities - mass, energy, and momentum balances - and explain how each balance is applied to a stirred-tank reactor and a drying operation.

Derive dimensionless groups (Reynolds, Nusselt, Prandtl, Schmidt) and state the transport regime each group characterizes in mixing, heat transfer, and mass transfer.

Compute mixing time, power number, and impeller power draw for a given tank geometry using standard correlations, and identify which variables dominate the result.

Explain particle-size reduction and size-classification principles, including the equipment families used for milling, sieving, and air classification, and the material properties that govern their selection.

Solve fluid-flow and pressure-drop problems through packed beds, filter media, and piping networks using Darcy, Ergun, and friction-factor relationships.

Distinguish the heat-transfer mechanisms in jacketed vessels, shell-and-tube exchangers, and freeze-dryer shelves, and calculate overall heat-transfer coefficients from film and wall resistances.

Analyze drying and evaporation operations by constructing a moisture-content versus drying-time curve and identifying the constant-rate and falling-rate periods.

Explain the working principles of the major unit operations (granulation, drying, milling, blending, compression, filtration, chromatography, lyophilization) and match each to its governing rate-limiting mechanism.

Apply the scale-up criteria - constant tip speed, constant power per unit volume, constant Reynolds number, and constant mixing time - and predict which quality attribute shifts when each criterion is held constant.

Construct a scale-up protocol from a 5 L bench reactor to a 2,000 L production reactor, specifying the geometric similarity assumptions and the parameters that must be verified at each step.

Interpret design-of-experiments output (main effects, interactions, response surfaces) and select operating ranges that define a design space for a critical process parameter.

Identify process risk using failure mode and effects analysis and rank parameters by severity, occurrence, and detectability to prioritize development effort.

Specify equipment design requirements for a given process, including materials of construction, surface finish, cleanability, and drainability, and justify each choice against product contact risk.

Evaluate equipment capacity and throughput by calculating batch cycle time, utilization, and bottleneck location for a multi-step process train.

Explain the design and operating principles of clean-in-place and steam-in-place systems, including coverage verification, flow velocity, and temperature requirements.

Select and size a filtration or chromatography step to meet a specified impurity clearance target, showing the calculation basis.

Map the regulatory framework - ICH quality guidelines, regional submission pathways, and pharmacopoeial requirements - to the lifecycle stages of a pharmaceutical product.

Write a specification and acceptance criteria for a drug substance and drug product, distinguishing critical quality attributes from non-critical attributes and justifying each limit.

Apply ICH stability guidance to design a stability study, including batch selection, storage conditions, testing intervals, and shelf-life extrapolation rules.

Explain change control and post-approval variation categories, and determine the reporting category for three representative changes.

Interpret an out-of-specification investigation flow and distinguish laboratory error, assignable cause, and true product failure.

Explain GMP requirements for personnel, premises, documentation, and material control, and identify the specific failure each requirement is designed to prevent.

Distinguish validation, qualification, and verification; write a validation master plan outline and a user requirement specification for a new piece of equipment.

Design an installation, operational, and performance qualification protocol, selecting the worst case and defining acceptance criteria for each stage.

Explain process validation in the lifecycle model, including continued process verification and the statistical tools used to detect drift.

Apply data-integrity principles (ALCOA+) to a documentation scenario and identify each violation present.

Conduct a hazard identification and risk assessment for a process involving a flammable solvent, applying the hierarchy of controls to each identified hazard.

Explain the principles of dust and vapor explosion protection, including zoning, ignition-source control, and inerting, and select appropriate equipment for a classified area.

Interpret environmental requirements for pharmaceutical operations - effluent limits, solvent recovery, and waste classification - and describe how each is monitored.

Describe occupational exposure control strategies, including containment levels, airborne concentration monitoring, and the use of occupational exposure limits.

Explain the elements of an emergency response plan for a chemical release and the reporting obligations that follow.

Synthesize the seven domains into an integrated process description that traces one product from raw material to release, naming the governing requirement at each step.

Diagnose weak areas using a timed 60-question mixed-domain practice set and categorize every missed question by domain and by error type.

Re-derive the 20 highest-yield calculations from memory, including scale-up ratios, drying time, pressure drop, and overall heat-transfer coefficient.

Explain the ten most commonly confused concept pairs (validation versus qualification, critical process parameter versus critical quality attribute, deviation versus nonconformance) in your own words.