PPB PharmTech key terms

A formal regulatory decision allowing a specific medicine to be sold and supplied in a jurisdiction, based on an assessed dossier covering quality, safety and efficacy, and tied to approved conditions of use.

A standardised five-module format for organising a medicine registration dossier, covering administrative data, quality summary, non-clinical and clinical summaries, and detailed study reports; regional modules add local requirements.

The approved reference document describing a medicine's composition, indications, dosing, contraindications, warnings, interactions and adverse reactions, used by prescribers and as the basis for labelling and patient information.

The approved, user-tested leaflet supplied inside a medicine pack, written in plain language for patients and covering what the medicine is, how to take it, and what risks to watch for.

A structured user test in which members of the public read a draft patient leaflet and answer questions to show they can find and understand key information before the text is approved.

A formal application to change an approved marketing authorisation, such as a new strength, manufacturer or indication; changes are classified by risk and some require prior approval before implementation.

The periodic re-assessment of a marketing authorisation after its initial validity period, where the regulator confirms, modifies or withdraws the authorisation based on updated benefit-risk and quality information.

A route where a medicine already authorised by one reference member state is assessed and recognised by other concerned member states, with national authorities cooperating on the shared assessment.

A registration route for medicines not yet authorised anywhere in the cooperating group, in which one reference authority leads assessment and other concerned authorities recognise the outcome for their own territories.

The set of quality-assurance requirements ensuring medicines are consistently produced and controlled to appropriate quality standards, covering premises, personnel, documentation, production, quality control and release.

The legal entity named on a marketing authorisation that is responsible for the product's compliance, including pharmacovigilance, labelling, supply and communication with the regulator throughout the product lifecycle.

A named, formally qualified individual at a manufacturing site who certifies each batch before release for sale, confirming it was produced and tested in accordance with GMP and the marketing authorisation.

A licence permitting an organisation to store, distribute and trade medicines at wholesale, subject to requirements on premises, qualified staff, record-keeping, traceability and handling of recalls.

Standards for the storage, transport and distribution of medicines that preserve quality and integrity, covering temperature control, security, traceability, returns and management of complaints and recalls.

The controlled sequence of storage and transport steps that keeps temperature-sensitive medicines within a validated range from manufacture to administration, supported by monitoring devices and excursion procedures.

Professional standards describing the pharmacist's role in promoting health, supplying medicines responsibly, and ensuring patient-centred care, including counselling, referral and appropriate use of medicines.

A patient-centred practice model in which the pharmacist takes responsibility for identifying, resolving and preventing medicine-related problems in partnership with the patient and other health professionals.

A written, approved instruction describing how a routine activity is performed, by whom, and what records are kept, so that work is done consistently and can be audited and improved.

Any preventable event that may cause or lead to inappropriate medicine use or patient harm, arising from prescribing, transcribing, dispensing, administration or monitoring, and reportable for learning and prevention.

A structured cycle of reflecting on practice needs, planning learning, taking part in learning activities, and recording and evaluating the outcome to maintain and improve professional competence.

A documented account of what was learned from an activity or incident, how it relates to the practitioner's role, and what will change in practice, often required as evidence of continuing development.

An organised set of knowledge, skills and behaviours expected at defined levels of practice, used to design training, assess performance and plan professional development for pharmacy staff.

Evidence that a person has completed defined training, including content, date, trainer, assessment result and competence sign-off, retained to demonstrate staff qualification during inspections.

An on-site or remote assessment by an authority to verify compliance with legal and good-practice requirements, using interviews, document review and facility observation, and resulting in findings and a report.

A structured response to a detected problem that removes its root cause and prevents recurrence, with documented actions, owners, deadlines and evidence that effectiveness has been verified.

A systematic investigation method used to trace a problem back to its underlying causes rather than its immediate symptoms, so that corrective and preventive actions address the real source.

A documented departure from an approved procedure, specification or expected result, which must be recorded, assessed for impact on product quality or patient safety, investigated and closed out.

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

An independent committee that reviews research plans and consent materials to protect participants' rights, safety and welfare before the study starts and through periodic continuing review.

The written plan for a clinical trial describing objectives, design, population, interventions, endpoints, safety monitoring and statistical methods, which investigators must follow and amendments must be approved.

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

A noxious and unintended response to a medicine at doses normally used, for which a causal relationship with the product is at least a reasonable possibility and which is assessed for reporting.

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

The process of reviewing individual case reports and aggregated data to identify a new or changed safety concern that warrants further assessment, and deciding whether regulatory or labelling action is needed.

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

The structured weighing of a medicine's demonstrated therapeutic advantages against its known and potential harms for the approved population, used in authorisation, variation, renewal and safety decisions.

A test result falling outside an approved specification, which triggers a documented laboratory investigation to determine whether it reflects a testing error, a manufacturing fault or a genuine product failure.

The formal decision that a manufactured lot may be released for supply, taken after review of production and testing records confirms compliance with specifications and authorised conditions.

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

Documented evidence that a process, method, system or facility consistently produces results meeting predetermined criteria, established before routine use and maintained through change control and revalidation.

A secure, computer-generated, time-stamped record of who created, modified or deleted data and why, enabling reconstruction of events during inspections and supporting data integrity.

The completeness, consistency and accuracy of records throughout their lifecycle, protected by controls such as access management, audit trails, backup and review so that decisions rest on trustworthy data.

A structured electronic submission format for regulatory dossiers, organised in a defined folder and index structure so authorities can navigate, review and archive applications consistently.

The removal or correction of a medicine already in the supply chain because of a quality, safety or labelling defect, classified by urgency and managed with traceability, notification and effectiveness checks.

A medicine that deliberately misrepresents its identity, composition or source, detected through market surveillance, testing and supply-chain controls, and subject to rapid alert and enforcement action.