PEGP Exam key terms

A process variable whose variation has a measurable effect on a critical quality attribute, so it must be monitored or controlled to keep the product within specification. Examples include temperature, pH, and fill volume.

A physical, chemical, biological, or microbiological property that must stay within an approved limit to ensure product safety and efficacy. CQAs are identified from the quality target product profile and drive control strategy design.

A prospective summary of the quality characteristics a drug product should have to meet patient needs, forming the starting point for quality by design. It guides identification of CQAs and the control strategy.

The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality. Working within the design space is not considered a change, but moving outside it normally requires a regulatory filing.

A systematic development approach that begins with predefined objectives and emphasizes product and process understanding and control, based on sound science and risk management. It relies on design space and control strategy rather than end-product testing alone.

A system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw materials, in-process materials, and processes. The goal is to ensure final product quality at the time of processing.

The systematic increase of batch size or equipment capacity from laboratory or pilot scale to commercial production while preserving product quality and process performance. It typically relies on geometric similarity, mixing, and heat and mass transfer calculations.

A small-scale representation of a commercial process, qualified to predict large-scale behavior, used for experiments, investigations, and validation support. Its predictive value must be demonstrated by comparability data against the commercial scale.

A dimensionless ratio of inertial to viscous forces used to characterize flow regime as laminar, transitional, or turbulent. In mixing and fluid transport design it helps predict whether agitation will produce adequate homogeneity or suspension.

The time required, after adding a tracer, for the contents of a vessel to reach a specified degree of homogeneity, commonly within five percent of the final value. It is a key criterion for comparing mixing performance across scales.

A single, discrete step in a manufacturing process that performs one physical or chemical transformation, such as filtration, drying, or blending. Processes are designed by combining linked unit operations, each with defined inputs and outputs.

An accounting of material entering, leaving, and accumulating within a process step or the whole process, based on conservation of mass. It supports yield calculations, loss identification, and equipment sizing.

A drawing that shows the sequence of major equipment and streams in a process, with flow directions and key operating conditions. It is distinct from piping and instrumentation diagrams, which add detailed piping, instruments, and control loops.

A detailed schematic showing piping, equipment, instruments, control loops, and utility connections in a process system. It is the reference document for hazard reviews, automation design, and change control.

Equipment that transfers thermal energy between two fluids separated by a barrier without mixing them. Common designs include shell-and-tube, plate, and double-pipe units, selected by duty, fouling tendency, and cleaning requirements.

A freeze-drying process in which a frozen product is dried by sublimation under vacuum, then by desorption of bound water. It is used for heat-sensitive products, and the critical parameters include shelf temperature, chamber pressure, and cycle time.

The set of regulatory requirements ensuring that medicinal products are consistently produced and controlled according to quality standards. It covers premises, equipment, personnel, documentation, production, and quality control in legally enforceable form.

The formal structure of policies, procedures, processes, and responsibilities used to direct and control an organization's quality activities. In the pharmaceutical context it includes change control, deviation handling, CAPA, and management review.

A departure from an approved instruction, procedure, or specification. Deviations are documented, assessed for product impact, and investigated according to their criticality, with corrective actions assigned when needed.

A structured process for eliminating the cause of a detected nonconformity (corrective) and the cause of a potential nonconformity (preventive). Effectiveness checks confirm that the action actually prevented recurrence.

A systematic investigation method used to identify the underlying reason a problem occurred, rather than only its symptoms. Common tools include the five-whys technique, fishbone diagrams, and fault tree analysis.

A test result that falls outside the acceptance criteria established in the specification or compendia. It triggers a phased laboratory investigation before any retest or resample decision, with defined regulatory reporting obligations.

A documented list of tests, references to analytical procedures, and acceptance criteria that a material or product must meet. Specifications are part of the regulatory commitment and cannot be relaxed without an approved variation.

A formal system by which qualified representatives review and approve proposed changes that may affect validated status, product quality, or regulatory filings. It ensures changes are evaluated, documented, and implemented without unintended consequences.

The completeness, consistency, accuracy, and reliability of data throughout its lifecycle. In regulated manufacturing it is supported by audit trails, access controls, and the ALCOA principles of attributable, legible, contemporaneous, original, and accurate records.

A secure, computer-generated, time-stamped record of who created, modified, or deleted electronic data and why. It must be reviewable and cannot be disabled or altered by users for regulated records.

Documented evidence that a computerized system consistently performs as intended in its intended use, including data integrity controls. It follows a risk-based lifecycle from requirements through qualification and periodic review.

A top-level document describing an organization's overall validation philosophy, scope, responsibilities, and schedule for facilities, equipment, utilities, and processes. It provides the framework under which individual validation protocols are executed.

The documented verification that equipment or systems are installed as designed and specified, including utilities, materials of construction, and vendor documentation. It precedes operational and performance qualification in the qualification sequence.

The documented verification that installed equipment or systems operate as intended throughout anticipated operating ranges. It tests functions, alarms, interlocks, and control limits, often under worst-case or challenge conditions.

The documented verification that a system or process, as installed and operated, consistently produces a product meeting predetermined acceptance criteria. It typically uses production batches, actual materials, and normal operating personnel.

The collection and evaluation of data, from process design through commercial production, establishing scientific evidence that a process is capable of consistently delivering quality product. The lifecycle approach has three stages: process design, qualification, and continued verification.

The ongoing stage of process validation in which routine production data are collected and statistically monitored to confirm the process remains in a state of control. It includes trending of critical parameters and quality attributes.

The use of control charts and statistical methods to monitor process stability and detect special-cause variation. In pharmaceutical manufacturing it supports continued process verification and timely investigation of shifts or trends.

A planned set of controls, derived from current product and process understanding, that ensures process performance and product quality. It may include material attributes, process parameters, in-process testing, and final product specifications.

A structured team-based technique that systematically examines deviations in process parameters, using guide words, to identify hazards and operability problems. It is a core element of process safety management for new and modified facilities.

A regulatory and management framework aimed at preventing catastrophic releases of highly hazardous chemicals. It covers process hazard analysis, operating procedures, training, mechanical integrity, management of change, and incident investigation.

A formal process for reviewing and approving changes to facilities, processes, or procedures that could affect safety or quality. It ensures hazards are evaluated and documentation, training, and drawings are updated before the change is implemented.

The ability to evaluate and ensure the quality of in-process or final product based on process data, including validated predictive models and PAT measurements, rather than solely on end-product laboratory testing. It requires a robust control strategy and regulatory agreement.