PPB Pharmacist Pre-registration Exam cheat sheet

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

Full (standalone) applications must contain a complete CTD Module 3 quality dossier plus non-clinical (Module 4) and clinical (Module 5) data; no reliance on a comparator product is permitted.

Abridged applications rely on bibliographic data or a hybrid/generic route; a generic must demonstrate essential similarity to a reference product and bioequivalence unless a biowaiver criterion applies.

The Common Technical Document has five modules: 1 regional administrative, 2 quality summaries, 3 quality, 4 non-clinical, 5 clinical; Module 1 content differs by jurisdiction.

Assessment clocks are typically split into validation, primary assessment (around 120-150 working days), and secondary assessment; the applicant's response time to a list of questions is excluded from the clock.

A validated application must be decided within the statutory timeline; a negative decision must state grounds and the applicant has a right of review or appeal within a defined period.

Fixed-combination products require justification of the combination (additivity, dose rationale) and, where relevant, a biowaiver or bioequivalence study against the combination rather than each single agent.

Orphan or priority-review designations shorten assessment timelines but do not waive quality, safety, or efficacy requirements; designation is granted before or during assessment, not after.

A premises licence is site-specific and activity-specific: wholesale, retail, import, export, and manufacturing each require separate authorisation or endorsement.

A Responsible Person (RP) for wholesale distribution must hold a pharmacy or relevant scientific degree and have demonstrable experience; the RP's name is recorded on the licence and changes must be notified.

Good Distribution Practice (GDP) requires temperature mapping of storage areas, validated cold chain, qualification of suppliers and customers, and a documented recall procedure.

Licences are time-limited in many jurisdictions (often one to five years) and renewal requires evidence of continued compliance, not merely payment of a fee.

A licence holder must notify the authority of changes to the responsible person, registered address, or scope of activities within a defined period, typically 14-30 days.

Manufacturing licences name authorised dosage forms and the named qualified person (QP) who certifies each batch for release; batch certification cannot be delegated to an unqualified person.

Licensing inspections may be announced or unannounced; refusal to permit entry is itself a ground for suspension or revocation.

Import/export licences require verification of the overseas manufacturer's GMP status and, for unapproved products, a named-patient or special-access pathway.

Good Pharmacy Practice requires that the pharmacist's role be patient-centred: assessment of the presenting condition, selection of therapy, counselling, and follow-up, not merely dispensing.

A prescription must be validated for legality (prescriber authority, date, patient identifiers, drug, dose, directions) before dispensing; incomplete or forged prescriptions must not be dispensed.

Dispensing errors are managed through a documented standard operating procedure covering detection, quarantine of the affected batch, patient contact, and reporting.

The seven rights of medicines administration (right patient, medicine, dose, route, time, documentation, reason) are the standard checking framework for dispensing.

Extemporaneous preparations require a documented master formula, a worksheet per preparation, and a beyond-use date justified by stability data or published references.

Counselling must cover dose, frequency, duration, key adverse effects, interactions with food or alcohol, and storage; a record of the counselling should be retained.

Prescription retention periods vary (commonly two years for private prescriptions, longer for controlled drugs); controlled-drug registers must be kept current and reconciled.

Pharmacists must apply a triage rule: refer to a prescriber when red-flag symptoms, pregnancy, paediatrics, or significant comorbidity are present rather than treat empirically.

CPD is a cycle: reflection on practice, identification of learning needs, planning, action, and documented evaluation of the effect on practice.

A CPD record must state what was learned and how it changed practice; attendance certificates alone do not satisfy the requirement.

Typical annual CPD requirements range from 20 to 40 hours or credits, with a proportion required to be verifiable or accredited.

Pre-registration training requires a defined supervised period (commonly 52 weeks or equivalent) plus a competency portfolio signed off by the tutor.

Accredited providers must map learning outcomes to the competency framework and declare any commercial sponsorship or conflict of interest.

Mandatory topics (e.g., safeguarding, infection control, pharmacovigilance) are usually set by the regulator and are additional to elective CPD.

CPD records are subject to audit; a random sample of registrants is asked to submit records, and failure to produce them can lead to conditions on registration.

Trainers/tutors must themselves be registered and trained in assessment; the tutor-to-trainee ratio and supervision level are set by the regulator.

Inspection types include routine/periodic, triggered/for-cause, follow-up, and pre-authorisation inspections; each has a different scope and notice period.

GMP inspection findings are graded critical, major, or minor; a critical finding indicates a real or potential risk of harm and normally leads to suspension or refusal of a licence.

A CAPA (corrective and preventive action) plan must address root cause, not just the observed defect, with named owners and completion dates.

Inspectors may take samples, photocopy records, and interview staff; the inspection report is the formal record and the company has a defined period to respond.

Risk-based inspection frequency considers product type (sterile, biological), prior compliance history, and complexity of the site; a poor history shortens the interval.

Data integrity is assessed against ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available); audit trails must be enabled and reviewed.

A close-out letter or certificate is issued only after the CAPA evidence is accepted; an inspection is not closed by submission of the plan alone.

Mutual recognition of inspections between authorities depends on equivalence assessment; a foreign inspection report may be accepted but does not automatically replace a national licence.

A clinical trial requires prior authorisation from the competent authority and a favourable opinion from an independent ethics committee before any participant is enrolled.

Informed consent must be obtained before any trial-related procedure, be documented, and be re-obtained if the protocol or risk profile changes materially.

The sponsor must report serious adverse events (SAEs) to the authority within defined timelines (commonly 7 days for fatal/life-threatening, 15 days for other serious events).

An annual safety report and a development safety update report (DSUR) summarise accumulating safety data for the investigational product.

Substantial amendments to the protocol require authorisation or notification before implementation, except urgent safety measures, which must be notified promptly afterwards.

Good Clinical Practice requires a trial master file, source document verification, monitoring, and an audit trail linking source data to the case report form.

Trial registration in a public registry before first enrolment is a condition of publication and, in many jurisdictions, of authorisation.

The sponsor must notify trial end and submit a summary of results within a defined period (often one year) after the end of the trial.

Post-market surveillance combines spontaneous reporting, periodic safety update reports, and active surveillance such as cohort event monitoring.

A recall is classified by health hazard: Class I (serious harm or death likely), Class II (temporary or reversible harm), Class III (unlikely to cause harm); class drives urgency and communication.

Recall effectiveness is measured by the proportion of affected units accounted for; a target recovery rate is set and a low rate escalates the action.

A product defect report should capture batch number, expiry, nature of defect, quantity distributed, and distribution list so that stock can be traced.

Suspected substandard or falsified products must be reported to the authority and the WHO global surveillance system; they must be quarantined and not returned to stock.

Market surveillance sampling is risk-based and targeted at products with prior defects, complex manufacturing, or high volume; results feed the inspection programme.

A marketing authorisation holder must maintain a batch record and distribution record for the retention period so that a recall can be executed within hours.

Enforcement options escalate from warning letter to suspension, revocation, seizure, and prosecution; proportionality and public health risk determine the level.

An individual case safety report (ICSR) requires four elements: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event.

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

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

Expedited reporting timelines: 15 calendar days for serious unexpected suspected adverse reactions; 90 days for non-serious or non-expedited cases in many systems.

A signal is information suggesting a new causal association or a new aspect of a known association; it must be validated and assessed, and confirmed signals lead to labelling changes.

The periodic benefit-risk evaluation report (PBRER) replaces the PSUR under ICH E2C(R2), with reporting frequency set by the product's risk and approval date.

Risk management plans specify pharmacovigilance activities and risk-minimisation measures; their effectiveness must be evaluated, not merely implemented.

The qualified person for pharmacovigilance (QPPV) is responsible for the PV system and must be contactable at all times; the role cannot be outsourced without a named deputy.

An analytical method must be validated for specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness, and solution stability as applicable.

System suitability testing is run before each analytical batch; acceptance criteria for tailing factor, theoretical plates, and %RSD must be pre-defined in the method.

Out-of-specification (OOS) results trigger a phase I laboratory investigation before retesting; retesting is permitted only under a written, approved plan.

Out-of-trend (OOT) results are investigated even when within specification, because they may indicate a process shift before failure occurs.

Reference standards must be qualified against a primary standard; working standards are re-quantified and assigned an expiry.

Stability studies use ICH climatic zones: Zone I/II (21°C/45% RH, 25°C/60% RH), Zone III (30°C/35% RH), Zone IVa/IVb (30°C/65% RH or 30°C/75% RH).

Accelerated stability is 40°C/75% RH for six months; a significant change (e.g., 5% assay change) triggers intermediate condition testing.

Lot release by an official control laboratory applies to biologics and vaccines in many jurisdictions; the national control laboratory issues a release certificate per batch.

Electronic records must comply with ALCOA+ and 21 CFR Part 11 or equivalent: unique user accounts, no shared logins, and access controls by role.

Electronic signatures must be linked to their record, show the signer's name and date/time, and be invalidated if the record is altered afterwards.

Audit trails must be computer-generated, time-stamped, and cannot be switched off; the trail must be reviewed as part of batch release.

The eCTD is the standard electronic submission format, with an XML backbone and defined module structure; lifecycle sequences must reference the previous sequence.

Validation of computerised systems follows a lifecycle: user requirements, functional specification, IQ/OQ/PQ, and periodic review; risk assessment determines the depth of validation.

Data backup and disaster recovery must be tested; restoration must be demonstrated, not assumed, and the test documented.

Online reporting portals for adverse events and defects require the same data quality as paper; a submission reference number must be retained.

Hybrid systems (paper plus electronic) are acceptable only if the complete record is retrievable and the paper-electronic link is unambiguous.