PPB Pharmacist Pre-registration Exam flashcards

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

Marketing authorisation scope

An MA covers one product, one pharmaceutical form, one strength, and one presentation. Changing any of these requires a variation or a new application.

CTD Module 3

The quality module of the Common Technical Document. It contains drug substance and drug product data, control of excipients, analytical procedures, and stability data.

Generic essential similarity

A generic must contain the same active substance, same strength and form, and demonstrate bioequivalence to the reference product unless a biowaiver applies.

Assessment clock

The regulatory review period, typically split into validation, primary and secondary assessment. Applicant response time to questions is excluded from the clock.

Responsible Person (GDP)

The named individual on a wholesale distribution licence who ensures Good Distribution Practice compliance. Must hold a relevant degree and documented experience.

GDP temperature mapping

A documented study proving that storage areas hold temperature within range across seasons and at all locations, including worst-case points near doors and ceilings.

Qualified Person batch release

The named QP certifies each manufacturing batch for release after confirming manufacture and testing complied with the marketing authorisation and GMP.

Premises licence scope

A licence is site-specific and activity-specific. Wholesale, retail, import, export, and manufacturing each need separate authorisation or endorsement.

Prescription validation

Checking prescriber authority, date, patient identifiers, drug, dose, and directions before dispensing. Incomplete or forged prescriptions must not be dispensed.

Seven rights of administration

Right patient, medicine, dose, route, time, documentation, and reason. Used as the standard checking framework during dispensing and administration.

Extemporaneous beyond-use date

The expiry assigned to a compounded preparation, justified by stability data or published references, and documented on the worksheet with the master formula.

Counselling record

A retained note that dose, frequency, duration, key adverse effects, interactions, and storage were explained to the patient at dispensing.

CPD cycle

Reflection on practice, identification of learning needs, planning, action, and evaluation of the effect on practice. Attendance alone does not satisfy it.

Pre-registration training period

A defined supervised training period, commonly 52 weeks or equivalent, with a competency portfolio signed off by an approved tutor.

CPD audit

A regulator's random sample check of registrants' CPD records. Failure to produce adequate records can lead to conditions on registration.

Critical inspection finding

A GMP finding indicating a real or potential risk of harm to patients. It normally leads to suspension or refusal of a licence.

CAPA root cause

Corrective and preventive action must address the underlying cause of a finding, with named owners and dates, not only the observed defect.

ALCOA+ data integrity

Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available. Audit trails must be enabled and reviewed.

Inspection close-out

Issued only after the authority accepts CAPA evidence. Submitting a plan alone does not close an inspection or restore a licence.

Informed consent timing

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

SAE reporting timelines

Serious adverse events are reported to the authority within about 7 days for fatal or life-threatening events and 15 days for other serious events.

Substantial amendment

A protocol change affecting safety, rights, or scientific validity. It needs authorisation or notification before implementation, except urgent safety measures.

Trial registration

Public registration of a clinical trial in a recognised registry before first enrolment. It is a condition of publication and often of authorisation.

Recall classification

Class I: serious harm or death likely. Class II: temporary or reversible harm. Class III: unlikely to cause harm. Class sets urgency and communication.

Recall effectiveness

The proportion of affected units accounted for after a recall. A low recovery rate escalates the action and widens the communication.

Substandard or falsified product

A product failing specifications or misrepresenting identity, composition, or source. It must be quarantined and reported, never returned to stock.

ICSR four elements

An identifiable patient, an identifiable reporter, a suspect product, and an adverse event. All four are needed for a valid case safety report.

Seriousness criteria

Death, life-threatening event, hospitalisation or prolongation, persistent disability, congenital anomaly, or a medically important event requiring intervention.

Expectedness assessment

Judged against the reference safety information in the company core data sheet or approved product information, not against general pharmacological knowledge.

Pharmacovigilance signal

Information suggesting a new causal association or a new aspect of a known one. It must be validated, assessed, and acted on if confirmed.

OOS investigation phases

A phase I laboratory investigation precedes any retesting. Retesting is allowed only under a written, approved plan with predefined acceptance criteria.

ICH climatic zones

Zone I/II 21°C/45% RH and 25°C/60% RH; Zone III 30°C/35% RH; Zone IVa 30°C/65% RH; Zone IVb 30°C/75% RH.

Accelerated stability condition

40°C/75% RH for six months. A significant change, such as a 5% assay change, triggers intermediate condition testing.

Official lot release

A national control laboratory tests and certifies each batch of certain biologics and vaccines before the batch can be marketed.

Electronic signature linkage

An e-signature must be linked to its record, show signer name and date/time, and be invalidated if the record is altered afterwards.

Audit trail requirement

A computer-generated, time-stamped record of creation, modification, and deletion of data. It cannot be switched off and must be reviewed.

eCTD lifecycle sequence

An electronic submission format with an XML backbone. Each lifecycle sequence must reference the previous sequence and state the operation applied.