PPB Pharmacist Exam flashcards

33 cards. Read the term and the definition here. The deck at the top of this page is optional.

Marketing authorisation scope

An MA covers a specific product, strength, and pharmaceutical form. Changing any of these requires a variation or a new application, not automatic extension of the existing authorisation.

CTD module structure

The Common Technical Document has five modules: regional administrative information, quality summaries, quality, nonclinical, and clinical. Reviewers expect this fixed order in every submission.

Abridged application basis

An abridged application relies on similarity or bioequivalence to a reference product, replacing full nonclinical and clinical data with bridging evidence and published literature justification.

MAH legal responsibility

The marketing authorisation holder remains legally accountable for the product on the market even when manufacturing and batch release are outsourced to contracted sites.

Wholesale dealer licence

A wholesale dealer licence authorises storage and distribution of medicines. It does not authorise manufacture or retail supply to patients, which need separate authorisations.

Named person condition

Licences name accountable individuals such as a responsible pharmacist or qualified person. If that person leaves, the licensed activity may be suspended until a replacement is approved.

Good Distribution Practice

GDP governs wholesale storage and transport. Core requirements include temperature mapping, validated cold chain, qualification of suppliers and customers, and traceable distribution records.

Licence variation triggers

Relocation, significant premises alteration, or a change of named responsible person requires notification or variation before the activity continues at the new arrangement.

Prescription review sequence

Check legality and completeness, then clinical appropriateness, dose and duration, interactions, and finally dispensing, labelling, and counselling before handover.

High-alert medicine check

Medicines such as anticoagulants, insulin, and concentrated electrolytes require independent double-checks and clear differentiation of strengths to prevent harmful selection errors.

Extemporaneous preparation record

Each preparation needs a documented formula, validated method, assigned beyond-use date supported by stability data, and a record linking batch, patient, and preparer.

Tall-man lettering

Look-alike and sound-alike medicine names are differentiated by uppercase lettering, physical separation on shelves, and read-back verification of verbal orders.

CPD cycle steps

Continuing professional development runs as a cycle: reflect on practice, identify a need, plan learning, act, record evidence, then evaluate the impact on practice.

CPD evidence standard

Certificates prove attendance only. Valid CPD evidence shows what was learned and what changed in practice, recorded contemporaneously and verifiable on inspection.

Training record content

Training records must show content, date, trainer competence, and assessment of understanding. They are inspection evidence that the person is competent for the task.

Inspection finding classification

Findings are graded critical, major, or other. A critical finding indicates direct patient risk, such as falsified data or gross contamination, and may trigger suspension or recall.

CAPA root cause

A corrective and preventive action response must identify root cause, define corrective and preventive steps, set timelines, and include an effectiveness check.

Inspection opening and closing

The opening meeting confirms scope, agenda, and contacts. The closing meeting presents preliminary findings and their classification before the formal report is issued.

Product trail inspection

Inspectors follow the product from starting materials through batch records, deviations, complaints, recalls, and quality management review to test system effectiveness.

Trial authorisation prerequisite

No participant may be enrolled until ethics committee approval and regulatory authorisation are both in place, and informed consent has been documented.

SAE reporting clock

The investigator reports serious adverse events to the sponsor within 24 hours of becoming aware. The sponsor then assesses causality and expectedness for onward reporting.

SUSAR timelines

Suspected unexpected serious adverse reactions are reported within 7 days if fatal or life-threatening and within 15 days for other serious reactions, with follow-up information.

Source data attributes

Source data must be attributable, legible, contemporaneous, original, and accurate. Trial files must allow full reconstruction of participant data and decisions.

Recall class definitions

Class I recalls address products likely to cause serious harm or death. Class II covers temporary or reversible harm, and Class III covers unlikely harm.

Recall effectiveness measure

Recall effectiveness is the response rate achieved against quantity distributed. The recall closes only when the agreed target response rate is reached.

Falsified versus substandard

Falsified medicines misrepresent identity, history, or source deliberately. Substandard medicines fail quality specifications, often through manufacturing error rather than intent.

Valid ICSR elements

A valid individual case safety report needs an identifiable reporter, an identifiable patient, a suspect product, and an adverse event. Missing any element makes it invalid.

Seriousness criteria

An event is serious if it causes death, is life-threatening, requires hospitalisation or prolongation, causes persistent disability, is a congenital anomaly, or is medically important.

Expectedness reference

Expectedness is judged against the reference safety information such as the approved product information or company core data sheet, not against general clinical knowledge.

Signal definition

A signal is information suggesting a new causal association or a new aspect of a known association, judged against observed versus expected reporting rates.

OOS investigation phase

An out-of-specification result triggers a phase I laboratory investigation before any retest. Retesting needs a pre-approved plan and documented justification.

Analytical method validation

Validation covers specificity, linearity, accuracy, precision, range, detection and quantitation limits, and robustness, documented against predefined acceptance criteria.

eCTD technical validation

Electronic submissions must pass technical validation of structure and file formats before scientific review begins. A failed validation blocks the entire review.