PPB Pharmacist Exam key terms

The formal decision by a national regulatory authority permitting a specific medicinal product to be placed on the market and used under stated conditions, based on an assessed application dossier covering quality, safety and efficacy.

The legal person or company named on a marketing authorisation who is responsible for the product's compliance, including pharmacovigilance obligations, batch release arrangements and communications with the regulator throughout the product lifecycle.

A harmonised application format organised into five modules covering administrative data, summaries, quality, non-clinical and clinical information, used to submit marketing authorisation dossiers in a consistent structure across regions.

A formal application to change an authorised product's details, such as formulation, manufacturing site, shelf life or labelling; changes are classified by impact and require prior approval or notification before implementation.

The set of quality-assurance requirements ensuring medicinal products are consistently produced and controlled to quality standards appropriate to their intended use, covering premises, personnel, documentation, validation and quality control.

A named individual with specified education and experience who certifies, before release for sale or supply, that each batch was manufactured and tested in accordance with GMP and the marketing authorisation.

The documented account of a manufacturing batch, including materials used, equipment, process steps, in-process checks and test results, retained to allow full traceability and retrospective investigation of quality defects.

The authorised decision, following review of manufacturing and control records, that a batch is suitable to be released for sale or supply; for some products an official lot-release certificate from an authority is additionally required.

Independent testing and certification of a batch by a designated regulatory laboratory before the product may be supplied, typically applied to biologicals such as vaccines where batch-to-batch consistency is critical.

A stored portion of each batch kept under defined conditions for a specified period so that the product's quality can be re-examined if complaints, recalls or stability questions arise.

The testing and sampling activities performed against defined specifications to confirm that raw materials, intermediates and finished products meet predetermined criteria for identity, strength, purity and other quality attributes.

A test result that falls outside established acceptance criteria; it triggers a documented laboratory investigation to determine whether the cause is analytical error, manufacturing failure or another root cause before any retesting decision.

The documented list of tests, references to analytical procedures and acceptance criteria that a material or product must meet to be considered acceptable for its intended use.

A structured programme of testing product samples over time under defined temperature, humidity and light conditions to establish shelf life, storage requirements and compatibility with container closure systems.

An on-site examination by authority inspectors of facilities, processes, records and personnel to verify compliance with GMP, good distribution or pharmacovigilance obligations, resulting in a report and possibly a compliance certificate or enforcement action.

A documented departure from an approved procedure, specification or regulatory requirement; it must be recorded, assessed for impact on product quality and patient safety, and investigated with appropriate corrective action.

A structured process for eliminating the cause of a detected nonconformity and preventing its recurrence or occurrence elsewhere, including root-cause analysis, implementation, effectiveness checks and documentation.

A systematic process for assessing, controlling, communicating and reviewing risks to product quality across the lifecycle, used to prioritise resources and justify decisions such as validation scope and testing frequency.

The documented evidence that a process, method, system or equipment consistently produces a result meeting predetermined criteria; prospective, concurrent and retrospective approaches exist depending on the activity.

The documented verification that equipment, facilities or utilities are correctly installed, operate as intended and perform reproducibly, typically staged as design, installation, operational and performance qualification.

Requirements covering procurement, storage, transport and supply of medicines in the distribution chain, including temperature control, traceability, authorised sources and management of returns and falsified products.

A licence granted to an entity permitting storage and supply of medicinal products to pharmacies, clinics or other authorised parties, subject to GDP compliance, named responsible persons and inspection.

The named individual within a distribution organisation who ensures that GDP requirements are met and that quality management, documentation and training systems operate effectively throughout storage and transport activities.

Professional standards describing the role of pharmacists in meeting patients' medicine-related needs, covering dispensing accuracy, patient counselling, premises, documentation, infection control and ethical conduct.

A written, approved instruction describing how a routine activity is performed, by whom, with what records, so that tasks are carried out consistently and can be audited or reconstructed after the event.

A structured, reflective cycle in which a professional identifies learning needs, plans and records learning activities, applies them in practice and evaluates the outcome, documented as evidence of maintained competence.

A documented schedule of required and developmental training for staff, specifying content, method, responsible trainer, completion date and how competence will be verified and recorded.

A structured evaluation, using observation, questioning or testing, of whether a person can perform assigned tasks to the required standard, with results recorded and gaps addressed through further training.

Formal approval by a competent authority allowing a sponsor to conduct a clinical trial in a jurisdiction, granted after assessment of the protocol, investigational product dossier and participant protection arrangements.

A participant's voluntary agreement to take part in research after receiving understandable information about purpose, procedures, risks, benefits, alternatives and rights, documented by signature and date before any trial activity.

An independent committee that reviews research protocols and consent materials to protect participants' rights, safety and welfare, and which must approve a trial before it begins and after substantial amendments.

The individual, company or institution that initiates, manages and finances a clinical trial, and which holds legal responsibility for its conduct, safety reporting and regulatory submissions.

An untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongs it, causes persistent disability, is a congenital anomaly, or is otherwise medically important, requiring expedited reporting.

The science and activities relating to detecting, assessing, understanding and preventing adverse effects or any other medicine-related problem, spanning spontaneous reporting, signal detection and risk minimisation.

A response to a medicinal product that is noxious and unintended, arising from its authorised use, off-label use, overdose, misuse or occupational exposure, and which forms the core of safety reporting.

A structured record of a single suspected adverse reaction, containing patient details, suspect product, event description, outcome, reporter and causality assessment, submitted to the authority within defined timelines.

The systematic review of case reports and aggregate data to identify new or changed safety information suggesting a previously unrecognised hazard, or a change in frequency or severity, requiring further evaluation.

A periodic submission by the marketing authorisation holder summarising worldwide safety data, exposure, signals and benefit-risk balance for a product over a defined reporting interval.

The named individual responsible for establishing and maintaining the pharmacovigilance system, having oversight of safety data, signal evaluation and regulatory communication, and contactable at all times.

The removal or correction of a medicine already supplied because of a quality defect or safety concern, classified by urgency, with defined communication, retrieval, reconciliation and reporting steps.

The assignment of a unique identifier to each saleable pack, applied and verified through the supply chain, enabling authentication, tamper evidence and traceability, and supporting detection of falsified products.

A regulated digital platform used for submissions, notifications, licensing transactions or data exchange with the authority, requiring user accounts, controlled access, data integrity and retention of submission receipts.