PPB Pharmacist Exam cheat sheet

A marketing authorisation (MA) is product-, strength-, and pharmaceutical-form specific; any change to these requires a variation or a new application.

Full dossier modules follow the CTD structure: Module 1 regional administrative data, Module 2 summaries, Module 3 quality, Module 4 nonclinical, Module 5 clinical.

Fixed-combination products require justification of the combination: each component must contribute to efficacy and safety, and the combination must not be merely additive without benefit.

Abridged applications rely on demonstration of similarity or bioequivalence to a reference product rather than full nonclinical and clinical data.

The MA holder (MAH) is legally responsible for the product on the market; manufacturing and batch release may be contracted but responsibility is not transferred.

A rejected application may generally be appealed within a defined period; re-submission requires addressing the specific grounds of rejection.

Orphan designation is granted before or during development and confers market exclusivity, separate from the MA itself.

Renewal of an MA is typically required after a fixed initial validity period; the MAH must confirm the benefit-risk balance remains positive.

Licensing covers premises, persons, and activities: a wholesale dealer licence authorises storage and distribution, not manufacture or retail supply.

A named qualified person (QP) or responsible pharmacist is a licence condition; absence of the named person can suspend the licensed activity.

Licences are site-specific; relocation or structural change to premises requires notification or variation before operation.

Good Distribution Practice (GDP) applies to wholesale; temperature mapping, validated cold chain, and traceable records are core licence conditions.

Licence suspension or revocation follows a defined regulatory process with a right to be heard; operating without a valid licence is an offence.

Import/export licensing is separate from domestic wholesale licensing and may require a manufacturing importer authorisation.

Retail pharmacy licensing typically requires a registered pharmacist present during opening hours and separation of prescription and OTC areas where mandated.

The prescription review sequence: legality and completeness, clinical appropriateness, dose and duration, interactions, then dispensing and labelling.

Dispensing records must allow reconstruction of the transaction: product, batch, quantity, date, prescriber, and patient.

Counselling points for a new medicine: indication, dose and timing, duration, key adverse effects, what to do if a dose is missed, and storage.

High-alert medicines (e.g., anticoagulants, insulin, concentrated electrolytes) require independent double-checks and clear differentiation of strengths.

Look-alike/sound-alike names require tall-man lettering, physical separation, and read-back verification of verbal orders.

Extemporaneous preparation requires a documented formula, validated method, and assigned beyond-use date based on stability data.

Antimicrobial stewardship in pharmacy practice: verify indication, duration, and de-escalation opportunities, and reinforce adherence counselling.

CPD is a cycle: reflect on practice, identify need, plan, act (learn), record, and evaluate the impact on practice.

CPD records must be contemporaneous and verifiable; certificates alone are not evidence of learning or of practice change.

Competency frameworks map learning to domains such as professional practice, communication, safety, and governance; gaps drive the learning plan.

Training for a new role (e.g., designated person, QP, responsible pharmacist) must be documented before the person assumes accountability.

Mandatory training typically includes pharmacovigilance reporting, GDP/cold chain, data protection, and safe handling of hazardous medicines.

Evaluation of CPD asks what changed in practice; a course attended without practice change is not a completed CPD cycle.

Training records are inspection evidence; they must show content, date, trainer competence, and assessment of understanding.

Inspection types: routine/periodic, for-cause, pre-authorisation (PAI), and follow-up; scope and notice period differ by type.

The opening meeting confirms scope, agenda, and contacts; the closing meeting presents preliminary findings and the classification (critical, major, other).

A critical finding indicates a direct risk to patients (e.g., falsified data, gross contamination); it can trigger suspension or recall.

CAPA responses must include root-cause analysis, not just the corrective action; inspectors evaluate effectiveness checks and timelines.

Inspection reports and non-compliance statements may be published; serious non-compliance can invalidate certificates of GMP.

Documents must be retrievable during the inspection window; retrospective reconstruction of records is itself a finding.

Inspectors follow the product trail: starting materials, batch records, deviations, complaints, recalls, and the quality management review.

A clinical trial requires prior ethics committee approval and regulatory authorisation before any participant is enrolled.

Informed consent must be obtained before any trial-related procedure; consent is documented, dated, and re-obtained when new information arises.

Good Clinical Practice (GCP) pillars: investigator qualifications, protocol adherence, source documentation, investigational product accountability, and safety reporting.

Serious adverse events (SAEs) are reported to the sponsor within 24 hours of the investigator becoming aware; the sponsor assesses causality and expectedness.

Suspected unexpected serious adverse reactions (SUSARs) are reported to regulators and ethics committees within defined timelines (e.g., 7 days fatal/life-threatening, 15 days otherwise).

Protocol deviations must be documented and assessed for impact on participant safety and data integrity; systematic deviations are reportable.

Trial master file and investigator site file must permit reconstruction of the trial; source data must be attributable, legible, contemporaneous, original, and accurate.

Post-market surveillance includes spontaneous reports, periodic safety update reports, literature monitoring, and signal detection from multiple sources.

A recall is classified by health hazard: Class I (serious harm/death likely), Class II (temporary or reversible harm), Class III (unlikely harm).

Recall effectiveness is measured by response rate against the quantity distributed; a recall is closed only when the target response rate is met.

Defective product investigations must trace batch distribution, quarantine remaining stock, and assess whether other batches are affected.

Falsified and substandard medicines are distinguished: falsified concerns identity/history/source misrepresentation; substandard is failure to meet quality specifications.

Market surveillance uses sampling and testing programmes, plus intelligence from wholesalers, healthcare professionals, and customs.

Risk communication to prescribers and patients (e.g., Dear Healthcare Professional letters) requires regulator agreement and measurable reach.

A valid individual case safety report (ICSR) requires an identifiable reporter, an identifiable patient, a suspect product, and an adverse event.

Seriousness criteria: death, life-threatening, hospitalisation or prolongation, persistent disability, congenital anomaly, or medically important event.

Causality assessment uses structured tools (e.g., WHO-UMC or Naranjo) and distinguishes related, possible, unlikely, and unassessable.

Expectedness is judged against the reference safety information (e.g., company core data sheet or approved product information), not against general knowledge.

Signal detection compares observed versus expected reporting; a signal is validated, then assessed, and may lead to labelling change or risk management measures.

Risk management plans include identified risks, potential risks, missing information, and pharmacovigilance plus risk-minimisation activities.

Periodic safety reports are submitted at defined intervals; the benefit-risk balance must be explicitly re-evaluated in each report.

Good Manufacturing Practice requires finished product testing against specification plus, where applicable, independent batch certification before release.

Analytical method validation parameters: specificity, linearity, accuracy, precision, range, detection/quantitation limits, robustness.

Out-of-specification (OOS) results trigger a phase I laboratory investigation before any retest; retesting requires a pre-approved plan and justification.

Out-of-trend (OOT) results indicate drift while still within specification; they signal process or method instability requiring investigation.

Stability studies support shelf life and storage conditions; significant change criteria differ for small molecules and biologics.

Reference standards must be qualified and traceable; working standards are calibrated against primary standards.

Data integrity in the laboratory rests on ALCOA+ principles; audit trails must be enabled, reviewed, and not editable without trace.

Electronic submissions use structured formats (e.g., eCTD) with a defined module structure and validated file formats; a failed technical validation blocks review.

Regulatory portals require role-based access; account sharing undermines the audit trail and is a compliance finding.

Electronic signatures are valid when linked to the signed record, uniquely attributable, and protected against later alteration.

Pharmacovigilance databases must support E2B electronic reporting and maintain a complete audit trail of case changes.

Serialisation and track-and-trace systems require unique product identifiers and verification at defined points in the supply chain.

System validation follows a documented lifecycle: user requirements, IQ/OQ/PQ, traceability matrix, and change control.

Online safety alerts and product recalls are disseminated through regulator channels; subscription to these channels is part of the surveillance process.