PPB PharmTech flashcards

39 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, dosage form, strength, and holder. Changes to any of these require a variation, extension, or transfer procedure rather than a fresh authorisation.

CTD five modules

Module 1 is regional administrative information; Module 2 quality summaries; Module 3 quality; Module 4 nonclinical; Module 5 clinical. The structure is harmonised under ICH M4.

Bioequivalence bridging

A generic applicant demonstrates that rate and extent of absorption are not clinically different from the reference product, usually via pharmacokinetic studies with defined confidence intervals.

Clock-stop period

Time during regulatory review when the assessment clock is paused because the applicant must answer questions. It is excluded from the published review timeline.

Qualified person batch certification

The QP legally certifies that each batch was manufactured and tested according to GMP and the marketing authorisation before release for sale or supply.

GDP wholesale licence

A licence to distribute medicines wholesale requires suitable premises, trained staff, a responsible person, temperature control, and documented traceability of all transactions.

Licensed scope breach

Operating outside the activities, premises, or personnel named on a licence is an unlicensed activity and can lead to enforcement action, suspension, or prosecution.

Prescription screening

Checking a prescription for legal validity, prescriber authority, dose appropriateness, interactions, contraindications, allergies, and completeness before dispensing begins.

Patient counselling elements

Counselling covers dose and frequency, administration technique, key adverse effects, missed-dose action, storage, and when to seek further medical help.

High-alert medication storage

Medicines carrying high risk of serious harm if misused are stored and labelled with distinct segregation and double-check steps to prevent selection errors.

Extemporaneous preparation record

A documented formula, source reference, method, beyond-use date, and risk assessment supporting a medicine prepared for an individual patient in the pharmacy.

CPD cycle stages

Reflect on learning needs, plan activities, act by completing learning, record evidence, and evaluate the impact on practice. A certificate alone does not close the cycle.

Training effectiveness assessment

Evidence that training achieved its aim, such as a test, observed task performance, or quality-metric change, rather than attendance records alone.

SOP revision training

Staff must be trained on a revised SOP before performing the changed task independently; training records are dated and attributable to each person.

Competency framework

A structured map of the knowledge, skills, and behaviours required for a role, used to identify gaps and plan targeted development.

Inspection finding grading

Findings are classified by risk to product quality or patient safety, typically critical, major, or other, and the grade sets the corrective-action deadline.

CAPA root cause

Correction fixes the specific instance; corrective action removes the cause to prevent recurrence; preventive action extends the fix to similar processes or sites.

Data integrity inspection focus

Inspectors check audit trails enabled, unique user accounts, no shared passwords, justified manual integration, and controlled spreadsheet calculations.

Closing meeting purpose

At inspection close, inspectors present preliminary findings and their basis, and the inspected site clarifies facts before the formal report is issued.

Informed consent elements

Freely given agreement after adequate information about purpose, procedures, risks, benefits, alternatives, confidentiality, and the right to withdraw without penalty.

SUSAR expedited reporting

A suspected unexpected serious adverse reaction must be reported to regulators and ethics committees within defined short timelines, with follow-up information as it arises.

Investigational product accountability

Records showing receipt, storage, dispensing to enrolled participants, return, and destruction of trial medication, reconciled at site and by the sponsor.

Essential documents retention

Trial records such as consent forms, protocols, and monitoring reports are kept for the required period after trial completion so conduct can be reconstructed.

Recall depth

The level to which a recall extends, from wholesale, pharmacy, or patient level, chosen according to the hazard and the distribution of the affected batches.

Defect classification

A grading of a product defect as critical, major, or minor according to health hazard, which then determines recall depth, urgency, and public notification.

Recall effectiveness check

Measurement of how many consignees were contacted and how much affected stock was recovered, documented in a report to the regulator.

Risk-based market sampling

Selection of products for testing based on prior failures, new manufacturers, narrow therapeutic index, or suspected falsification rather than random choice alone.

Valid ICSR four elements

An individual case safety report needs an identifiable reporter, identifiable patient, suspect product, and adverse event to be valid and processable.

Seriousness criteria

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

Expectedness judgement

Whether an adverse event is listed in the reference safety information such as the SmPC or investigator brochure; unlisted events are unexpected.

Signal detection

Review of case and aggregate data, including disproportionality statistics, to identify a new or changed causal association needing assessment and action.

OOS investigation sequence

First a laboratory investigation for error or instrument fault; if no cause is found, a full manufacturing investigation before any retest or resample decision.

Analytical method validation

Documented evidence of specificity, accuracy, precision, linearity, range, detection and quantitation limits, and robustness for the intended analytical procedure.

Reference standard control

Primary and working standards are qualified, assigned an expiry, stored correctly, and traceable, so that test results remain comparable over time.

Stability study purpose

Long-term and accelerated testing establishes shelf life, storage conditions, and degradation behaviour, supporting the labelled expiry and in-use period.

Portal submission acknowledgement

A system-generated receipt with a tracking number and timestamp confirming that a validated submission was accepted; it evidences the filing date.

Electronic signature attribution

A signature must be uniquely linked to one person and to the signed record; shared accounts or generic logins invalidate its legal and evidential value.

Portal access control

Role-based permissions and prompt deactivation of departed users limit who can submit, amend, or view regulatory records, and are checked during inspections.

Downtime submission procedure

A pre-agreed alternative channel and documented evidence of attempted submission protect filing deadlines when a regulatory portal is unavailable.