PPB PharmTech cheat sheet

An MA is granted per product, per dosage form and strength, per applicant; variations to an approved MA are handled through defined variation categories (minor/major, notification vs prior approval) rather than a new application.

Common submission formats: CTD/eCTD five-module structure (1 Administrative, 2 Quality, 3 Nonclinical, 4 Clinical, 5 Regional); ICH M4 governs structure, ICH M2 the electronic specification.

Abridged routes rely on demonstrating similarity or reliance: generics show bioequivalence to a reference product; reliance routes rely on a reference authority's assessment with a bridging/gap analysis.

Fixed combinations require justification of each active substance's contribution plus a combination rationale; a new strength or new indication normally requires an extension or variation, not a line extension alone.

Approval timelines are procedural clocks: validation (completeness) precedes scientific assessment; clock-stop periods for applicant responses are excluded from the review clock.

Orphan/expedited designations (priority review, conditional approval) trade faster access for post-authorisation obligations such as confirmatory studies.

Labelling and package leaflet are part of the authorisation; a mock-up or specimen must match the approved text, and artwork changes are controlled documents.

Post-approval lifecycle: renewals (often 5-year cycles), variations, transfers of MA holder, and withdrawals each have distinct regulatory procedures and fees.

A licence is site- and activity-specific: premises, named responsible person, and scope of operations (import, wholesale, manufacture, retail) are all assessed.

Wholesale distribution licences require GDP compliance: qualified person responsible for distribution, temperature-controlled storage, and documented traceability of each transaction.

Manufacturing licences require GMP compliance and a qualified person (QP) who certifies each batch before release; QP certification is a legal act, not a quality-control test.

Retail pharmacy licensing ties the licence to a registered pharmacist in charge; changes of superintendent or premises require notification or variation.

Licence applications typically require floor plans, equipment lists, SOPs, staff qualifications, and a self-inspection plan; inspectors verify these on site.

Licences are time-limited and renewable; operating after expiry, or outside licensed scope, is an unlicensed activity subject to enforcement.

Controlled-substance licences add separate authorisations for possession, supply, and record-keeping, with quota and security requirements.

A licence holder must notify significant changes (ownership, key personnel, major renovation) before or within a defined period of the change.

GPP covers the patient-care chain: prescription review, dispensing, counselling, monitoring, and referral; the pharmacist's duty is to the patient, not only to the product.

Prescription screening checks legality (prescriber authority, validity period), clinical appropriateness (dose, interactions, contraindications), and completeness.

Dispensing requires product identification, expiry check, correct labelling with directions, and a documented double-check for high-risk items.

Counselling elements: dose and frequency, administration technique, key adverse effects, what to do if a dose is missed, storage, and when to seek help.

Extemporaneous preparation needs a documented formula, source references, beyond-use dating, and a risk assessment for the preparation method.

Segregation rules: high-alert medications, look-alike/sound-alike names, and refrigerated or cold-chain items are stored and labelled to prevent selection error.

Records: prescriptions, dispensing logs, and interventions are retained per national retention periods; patient confidentiality governs disclosure.

Antimicrobial stewardship and pharmacovigilance reporting are routine GPP duties, not optional extras.

CPD is a cycle: reflect on needs, plan, act (learn), record evidence, and evaluate impact on practice; a certificate alone is not a completed cycle.

Competency frameworks map knowledge, skills, and behaviours to roles; gaps identified in appraisal or inspection findings drive the learning plan.

Training records must be contemporaneous and attributable: trainee, trainer, date, content, assessment method, and outcome.

GMP/GDP training is role-based and requires initial qualification plus periodic refresher; effectiveness must be assessed, not just attendance recorded.

Training on SOPs is required before independent task performance, and after any SOP revision that changes the task.

CPD credits or hours are commonly annualised with a minimum; audits may sample records to verify authenticity and relevance.

Trainer qualification and training-material version control are inspected items; uncontrolled or outdated materials are a common finding.

Evaluation levels progress from reaction (feedback) to learning (assessment) to behaviour (workplace observation) to results (quality metrics).

Inspection types: routine/periodic, for-cause, pre-approval, follow-up, and remote or hybrid; each has a defined scope communicated in advance.

Inspectors assess three things: the documented system (SOPs), the actual practice (observation, interviews), and the evidence (records, data).

Opening meeting sets scope and logistics; closing meeting presents preliminary findings; the formal report follows with a response deadline.

Findings are graded (e.g., critical/major/other) by risk to product quality or patient safety; grading drives the required corrective action timeline.

CAPA responses need root-cause analysis, not just a fix: correction addresses the instance, corrective action prevents recurrence, preventive action widens the scope.

Data integrity is a frequent focus: audit trails enabled, unique user logins, no shared passwords, and no backdating or uncontrolled spreadsheet calculations.

Inspectors may take samples, copy records, and interview staff privately; obstruction or inaccurate statements are themselves violations.

Repeat findings at follow-up can escalate to licence suspension, import bans, or GMP non-compliance statements published to regulators.

A trial needs prior ethics committee approval and regulatory authorisation before any participant is enrolled; substantial amendments require re-approval before implementation.

GCP (ICH E6) pillars: ethics, protocol adherence, informed consent, investigator qualification, investigational product accountability, and documentation.

Informed consent must be given freely, with capacity, adequate information, opportunity to ask questions, and the right to withdraw without penalty.

Sponsor duties include protocol, investigator selection, monitoring, safety reporting, and quality management; investigator duties include conduct and record-keeping.

Safety reporting: SUSARs are expedited to regulators and ethics committees within defined clocks; the investigator brochure or SmPC is the reference safety information.

Investigational product must be labelled for trial use, stored per protocol, dispensed only to enrolled participants, and reconciled with accountability records.

Essential documents must be retained per the applicable period after trial close-out; source data must be attributable, legible, contemporaneous, original, accurate.

Serious breach reporting, trial registration before first enrolment, and a final summary report are standard transparency obligations.

Surveillance combines inspections, sampling and testing, adverse-event signals, and complaint intelligence to detect non-compliant products on the market.

Risk-based sampling targets products with prior failures, new manufacturers, narrow therapeutic index, or known counterfeit routes.

Defect classification (critical/major/minor) determines action: recall depth (patient/pharmacy/wholesale level), public alerts, and regulatory follow-up.

Recall effectiveness must be measured: proportion of consignees contacted and stock recovered, documented in a recall report.

Unauthorised products, falsified medicines, and illegal online supply are handled through enforcement, seizures, and public warnings, not only recall.

Traceability systems (serialisation, unique identifiers) support verification and decommissioning of packs at the point of dispensing.

Market surveillance outputs feed back into licensing and MA decisions; repeated non-compliance can trigger licence review.

Communication channels: rapid alerts to healthcare professionals, public notices, and international regulator information-sharing.

Four elements of a valid individual case safety report: identifiable reporter, identifiable patient, suspect product, and 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 (e.g., SmPC or investigator brochure); unexpected plus serious plus suspected causal link = expedited report.

Signal detection uses disproportionality and clinical review; a signal is information suggesting a new causal association or a new aspect of a known one.

Periodic reports (PSUR/PBRER or local equivalents) include cumulative exposure and benefit-risk evaluation at defined intervals.

Risk management plans specify pharmacovigilance activities and risk-minimisation measures; effectiveness of these measures is evaluated.

The qualified person for pharmacovigilance (QPPV) oversees the system and must have access to a 24-hour safety contact.

Medication errors, lack of efficacy, overdose, and misuse are within the vigilance scope where they affect benefit-risk.

QC confirms compliance with specification; QA ensures the system that produces compliant results; the two are distinct functions.

Specification = tests, acceptance criteria, and analytical procedures; results outside criteria trigger an OOS investigation before any retest decision.

OOS investigation phases: laboratory investigation (error, instrument, method) then, if no cause, full manufacturing investigation including batch records and validation.

Analytical method validation parameters: specificity, accuracy, precision, linearity and range, LOD/LOQ, robustness; compendial methods need suitability verification.

Reference standards, columns, and reagents are controlled: qualification, expiry, storage, and traceability to a primary standard.

Data integrity in the lab: audit-trailed chromatography systems, no manual integration without justification, and retention of raw data and metadata.

Stability studies (long-term plus accelerated) set shelf life and storage conditions; out-of-trend results require investigation, not silent repeat.

Lot release by an official control laboratory or QP certification confirms each batch meets specification before market supply.

Regulatory portals provide structured submission (eCTD or web forms), validation of file format and metadata, and an acknowledgement with a tracking number.

Electronic signatures must be attributable and linked to the signed record; a shared account defeats the legal purpose of the signature.

Account security: unique credentials per user, role-based access, and prompt deactivation of leavers are inspection-relevant controls.

Submission validation errors must be resolved before the clock starts; the acknowledgement timestamp is the evidence of receipt.

Portals host licence and MA registers, safety reporting gateways, recall notification channels, and inspection-response uploads.

Data entered must match the underlying dossier; discrepancies between portal metadata and submitted documents cause validation or assessment queries.

System downtime procedures must exist: pre-agreed alternative channels and documented evidence of attempted submission.

Audit trails and submission archives must be retained for the record-retention period; portal copies alone are not a complete record.