NPC B.Pharm cheat sheet

A pharmacy is a health facility where medicines are compounded, dispensed, stored, and sold under the supervision of a registered pharmacist; ownership and operation require registration with the national pharmacy regulator.

A registered pharmacist holds a recognised pharmacy degree, has completed supervised practical training, and is entered on the register; only registered persons may dispense, compound, or sell medicines.

Prescription-only medicines may be supplied only on a valid prescription from a registered prescriber; the pharmacist must verify authenticity, legality, completeness, and clinical appropriateness before dispensing.

Controlled or narcotic medicines require special licensing, secure storage, a dedicated register, and record retention; a separate controlled drugs register is maintained for a specified period.

A prescription may be refused or dispensed with caution if illegible, incomplete, expired, or clinically inappropriate; the pharmacist must document the intervention and contact the prescriber where necessary.

Advertising of prescription medicines to the public is generally prohibited; advertising of over-the-counter medicines must be truthful, balanced, and must not claim to cure conditions requiring medical management.

Pharmacists have a duty to report adverse drug reactions to the national pharmacovigilance centre; serious reactions must be reported promptly, and causality assessment follows WHO-UMC criteria.

Record-keeping obligations include prescription records, controlled drug registers, purchase and sale invoices, and adverse reaction reports; retention periods vary by record type and jurisdiction.

The NPC Act establishes the national pharmacy council/regulator with functions of registration, licensing, inspection, standards-setting, and discipline of pharmacy practitioners.

The council is governed by a board or governing body appointed under the Act, with statutory committees for registration, education, and professional conduct.

Registration categories typically include full registration, provisional or intern registration, and temporary registration for visiting practitioners; each carries defined scope and conditions.

Only registered pharmacists may use protected titles and practise pharmacy; unregistered practice is an offence subject to penalty.

The Act defines professional misconduct and provides for investigation, inquiry, suspension, or removal from the register following due process.

The Act empowers inspectors to enter and inspect pharmacy premises, seize records, and require production of documents.

The Act sets out requirements for pharmacy premises, including adequate space, equipment, security, and supervision by a registered pharmacist.

The Act provides for appeals against registration or disciplinary decisions to a designated appellate body or court.

Good Manufacturing Practice (GMP) requires validated processes, qualified personnel, validated premises and equipment, documented procedures, and quality control testing at defined stages of production.

Good Distribution Practice (GDP) requires temperature-controlled storage and transport, qualified personnel, traceability, and a documented recall and returns system.

Standard operating procedures (SOPs) must be written, approved, version-controlled, and reviewed at defined intervals; deviations must be documented and investigated.

Validation follows a lifecycle: design qualification, installation qualification, operational qualification, performance qualification, and ongoing process verification.

Recall classification: Class I for products likely to cause serious harm or death, Class II for temporary or reversible harm, Class III for minor or no harm.

Stability testing follows ICH principles: long-term, intermediate, and accelerated conditions; accelerated testing typically at 40°C/75% RH for 6 months.

Pharmacovigilance guidelines require a qualified person for pharmacovigilance, periodic safety update reports, and signal detection from reported adverse events.

Clinical trial conduct requires ethics committee approval, informed consent, and adherence to Good Clinical Practice (GCP) principles.

pKa and pH relationship: for a weak acid, pH = pKa + log([A−]/[HA]); for a weak base, pH = pKa + log([B]/[BH+]).

Henderson–Hasselbalch equation underlies buffer design and drug ionisation; ionised species are less lipid-soluble and generally less membrane-permeable.

Beer–Lambert law: A = εcl; absorbance is proportional to concentration and path length, valid only at low concentration and monochromatic light.

Titration endpoints: equivalence point is stoichiometric; endpoint is the observed colour change; indicators must be chosen so their transition range brackets the equivalence pH.

Chromatographic parameters: retention factor k = (tR − t0)/t0; resolution Rs = 2(tR2 − tR1)/(w1 + w2); selectivity α = k2/k1; efficiency N = 16(tR/w)².

Quality control limits: assay limits are typically 95.0–105.0% of label claim; content uniformity and dissolution limits are specified in the pharmacopoeia.

Spectroscopic identification: IR for functional groups, UV-Vis for conjugated systems, NMR for proton environments, MS for molecular mass and fragmentation.

Impurity control follows ICH Q3A/Q3B thresholds; identification, qualification, and reporting thresholds depend on the maximum daily dose.

Bioavailability: F = (AUCoral × DoseIV)/(AUCIV × Doseoral) × 100%; absolute F compares to IV, relative F compares to a reference product.

Biopharmaceutics Classification System: Class I high solubility/high permeability, II low solubility/high permeability, III high solubility/low permeability, IV low/low.

Dissolution testing follows USP Apparatus I (basket) at 100 rpm or Apparatus II (paddle) at 50–75 rpm; sink conditions require the volume to be at least 3–10 times the saturation solubility.

Tablet compression: hardness, friability (≤1% weight loss), weight variation, disintegration, and dissolution are key quality attributes.

Sustained-release design uses matrix or reservoir systems; zero-order release follows Higuchi or Korsmeyer–Peppas models depending on mechanism.

Sterile products require terminal sterilisation or aseptic processing; sterility assurance level is 10⁻⁶; depyrogenation at 250°C for 30 minutes.

Ointments and creams: bases include hydrocarbon, absorption, water-removable, and water-soluble types; drug release depends on base partition coefficient.

Suspensions require flocculating agents, suspending agents, and controlled particle size; Stokes' law predicts sedimentation velocity.

Receptor pharmacology: agonists activate receptors; competitive antagonists shift the dose–response curve right without reducing maximal response; non-competitive antagonists reduce maximal response.

Pharmacokinetic parameters: clearance CL = Dose/AUC; volume of distribution Vd = Dose/C0; half-life t½ = 0.693 × Vd/CL.

First-order elimination gives a constant half-life; zero-order elimination gives a constant amount eliminated per unit time, as with ethanol and phenytoin at high doses.

Therapeutic drug monitoring is indicated for drugs with narrow therapeutic index, e.g., digoxin, lithium, phenytoin, vancomycin, and aminoglycosides.

Adverse drug reaction classification: Type A dose-dependent predictable; Type B idiosyncratic; Type C chronic; Type D delayed; Type E withdrawal; Type F unexpected failure.

Hypertension first-line therapy: thiazide diuretics, ACE inhibitors, ARBs, calcium channel blockers; ACE inhibitors are contraindicated in pregnancy and bilateral renal artery stenosis.

Diabetes: metformin is first-line for type 2; insulin is required in type 1; HbA1c target is generally <7% for most adults.

Clinical pharmacy interventions include medication reconciliation, dose adjustment for renal/hepatic impairment, therapeutic substitution, and patient counselling on adherence and administration.

Pharmacists must maintain professional indemnity insurance and comply with continuing professional development requirements for registration renewal.

Pharmacovigilance obligations extend to healthcare professionals and marketing authorisation holders; serious adverse reactions must be reported within 15 days.

The pharmacist-in-charge is responsible for the day-to-day operation of the pharmacy and for ensuring compliance with licensing conditions.

Dispensing errors must be documented and reported through the incident reporting system; near misses are reviewed for system improvement.

Confidentiality of patient information is a legal and ethical duty; disclosure is permitted only with consent or where required by law.

Pharmacy premises must be inspected before licensing and periodically thereafter; changes to premises or ownership require notification to the regulator.

Sale of medicines by unlicensed persons is prohibited; online pharmacy services must comply with the same standards as physical premises.

The Act provides for recognition of foreign qualifications subject to assessment and may require additional training or examination.

ICH Q1A stability testing: long-term 25°C/60% RH or 30°C/65% RH; intermediate 30°C/65% RH; accelerated 40°C/75% RH for 6 months.

ICH Q2 validation parameters include accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, and robustness.

ICH Q7 covers Good Manufacturing Practice for active pharmaceutical ingredients; Q9 covers quality risk management; Q10 covers pharmaceutical quality systems.

Marketing authorisation applications require a common technical document (CTD) with modules 1–5: administrative, quality, non-clinical, clinical, and regional information.

Batch release requires review of manufacturing records, quality control results, and deviation reports by a qualified person.

Change control must assess impact on product quality, safety, and efficacy; major variations require regulatory approval before implementation.

Audit trails and electronic records must comply with data integrity principles (ALCOA+: attributable, legible, contemporaneous, original, accurate, complete).

Handling of complaints and product returns requires investigation, root cause analysis, and corrective and preventive action (CAPA).

Acid–base extraction exploits pH-dependent ionisation; weak bases are extracted into organic solvent at high pH, weak acids at low pH.

Chirality: enantiomers have identical physicochemical properties except optical rotation and interactions with chiral environments; racemic mixtures require stereoselective assays.

Prodrug design improves absorption or targets drug release; ester prodrugs are hydrolysed by esterases; amide prodrugs are more stable.

Dissolution media selection depends on BCS class and dose; surfactants may be added for poorly soluble drugs; pH 1.2, 4.5, and 6.8 simulate gastrointestinal conditions.

Mass spectrometry: electrospray ionisation for polar compounds; MALDI for macromolecules; tandem MS provides structural information.

HPLC method development: mobile phase pH, organic modifier, column chemistry, and flow rate affect retention and resolution.

Karl Fischer titration measures water content; loss on drying measures volatile content; both are pharmacopoeial tests for moisture.

Reference standards must be traceable and characterised; system suitability tests confirm chromatographic performance before sample analysis.

Particle size reduction increases surface area and dissolution rate; micronisation may reduce flow and increase aggregation.

Excipient functions: diluents add bulk, binders improve granulation, disintegrants promote tablet breakup, glidants improve flow, lubricants reduce friction.

Coating: film coating for moisture protection and taste masking; enteric coating resists gastric acid and releases in the intestine.

Parenteral products must be isotonic, sterile, pyrogen-free, and pH-compatible; tonicity adjusters include sodium chloride and dextrose.

Aerosol delivery: metered-dose inhalers require propellants and surfactants; dry powder inhalers depend on particle size and inspiratory flow.

Transdermal systems: drug permeation through skin follows Fick's law; permeation enhancers and matrix design influence release.

Lyophilisation: freezing, primary drying (sublimation), and secondary drying (desorption); collapse temperature and eutectic point govern the process.

Quality by Design (QbD) identifies critical quality attributes and critical process parameters; design space defines acceptable operating ranges.

Antimicrobial therapy: beta-lactams inhibit cell wall synthesis; aminoglycosides bind 30S ribosome; macrolides bind 50S; fluoroquinolones inhibit DNA gyrase.

Antimicrobial resistance mechanisms include enzymatic inactivation, efflux pumps, target modification, and reduced permeability.

Anticoagulants: warfarin inhibits vitamin K epoxide reductase and is monitored by INR; heparin enhances antithrombin III and is monitored by aPTT.

Asthma management follows a stepwise approach: short-acting beta-2 agonists for relief; inhaled corticosteroids for control; add-on therapy for severe disease.

Renal dose adjustment uses creatinine clearance (Cockcroft–Gault) or eGFR; dose reduction or interval extension is required for renally cleared drugs.

Drug interactions: CYP450 inhibition increases substrate levels; induction decreases them; P-glycoprotein affects absorption and distribution.

Pharmacogenomics: CYP2C9 and VKORC1 variants affect warfarin dosing; CYP2D6 variants affect codeine activation and tamoxifen efficacy.

Patient counselling covers dose, frequency, route, timing, storage, missed doses, and reporting of adverse effects.

Prescription requirements typically include patient name, date, drug name, strength, dosage form, quantity, directions, and prescriber signature.

Repeat prescriptions require defined intervals and maximum repeats; the pharmacist must verify the last dispensing date.

Emergency supply of prescription medicines may be permitted without a prescription under defined conditions, with limits on quantity and duration.

Veterinary medicines are subject to separate licensing and may only be supplied by authorised persons.

Cosmetics and health supplements are regulated separately from medicines; claims must not imply therapeutic efficacy.

Waste medicines must be disposed of according to environmental regulations; controlled drugs require witnessed destruction and documentation.

Advertising and promotion of medicines must comply with codes of conduct; gifts and inducements to prescribers are restricted.

Continuing professional development records must be maintained and submitted for audit on request.

Good Clinical Practice requires a protocol, investigator's brochure, informed consent, and ethics committee approval before trial initiation.

Pharmacovigilance risk management plans include risk minimisation measures and post-authorisation safety studies.

Medical device regulations apply to devices with a medicinal component; classification depends on risk and duration of use.

Herbal medicines require evidence of quality, safety, and efficacy; monographs and traditional use registration pathways exist.

Biosimilars require comparative analytical, non-clinical, and clinical studies against a reference product.

Regulatory inspection findings are classified as critical, major, or minor; critical findings may lead to suspension of manufacturing.

Data integrity requirements include audit trails, access controls, and periodic review of electronic records.

Product labelling must include approved name, strength, batch number, expiry date, storage conditions, and instructions for use.

Spectrophotometric assay: choose wavelength of maximum absorbance; prepare calibration curve; validate linearity, accuracy, and precision.

Chromatographic system suitability: tailing factor, theoretical plates, resolution, and relative standard deviation of replicate injections.

Titration types: acid–base, redox, complexometric, and non-aqueous; non-aqueous titration is used for weak bases in glacial acetic acid.

pH measurement requires calibration with standard buffers at pH 4.0, 7.0, and 10.0; electrode maintenance affects accuracy.

Dissolution profile comparison uses f1 (difference) and f2 (similarity) factors; f2 ≥ 50 indicates similarity.

Impurity identification uses relative retention time and mass spectrometry; genotoxic impurities follow ICH M7 limits.

Stability-indicating methods resolve degradation products from the parent drug; forced degradation studies validate specificity.

Reference standard qualification includes assay, impurity profile, and structural confirmation.

Granulation methods: wet granulation improves flow and compressibility; dry granulation suits moisture-sensitive drugs.

Tablet defects include capping, lamination, picking, sticking, and mottling; causes relate to formulation, compression force, and tooling.

Capsule filling: hard gelatin capsules require powder flow and uniformity; soft gelatin capsules suit liquids and semisolids.

Suspension stability: flocculated suspensions settle rapidly but redisperse easily; deflocculated suspensions settle slowly but may cake.

Emulsion stability: creaming, flocculation, coalescence, and phase inversion; HLB value guides emulsifier selection.

Suppository bases: cocoa butter melts at body temperature; PEG bases dissolve; drug release depends on base lipophilicity.

Sterilisation methods: moist heat (121°C, 15 min), dry heat (160°C, 2 h), filtration (0.22 µm), radiation, and ethylene oxide.

Packaging: primary packaging contacts the product; secondary packaging provides protection and information; compatibility studies are required.

Cardiovascular drugs: statins inhibit HMG-CoA reductase; beta-blockers reduce heart rate and contractility; diuretics reduce fluid volume.

Diabetes drugs: metformin reduces hepatic glucose production; sulfonylureas stimulate insulin secretion; SGLT2 inhibitors increase urinary glucose excretion.

CNS drugs: benzodiazepines enhance GABA-A activity; SSRIs inhibit serotonin reuptake; antipsychotics block dopamine D2 receptors.

Analgesics: paracetamol acts centrally; NSAIDs inhibit cyclooxygenase; opioids act on mu receptors and cause respiratory depression.

Chemotherapy: alkylating agents cross-link DNA; antimetabolites inhibit nucleotide synthesis; anthracyclines intercalate DNA and cause cardiotoxicity.

Therapeutic drug monitoring: sample timing is critical; trough levels are measured for vancomycin and aminoglycosides; steady state is reached after 4–5 half-lives.

Adverse drug reactions: monitor for hypersensitivity, hepatotoxicity, nephrotoxicity, and haematological effects; report serious reactions promptly.

Medication reconciliation at admission, transfer, and discharge reduces discrepancies and adverse events.

Licensing of pharmacy premises requires a named pharmacist-in-charge and compliance with space, equipment, and record-keeping standards.

The regulator may suspend or revoke a licence for non-compliance; appeals follow statutory procedures.

Pharmacists must not practise while impaired or while registration is suspended.

Professional boundaries and consent are essential; patient autonomy must be respected.

Confidentiality exceptions include statutory reporting, court orders, and serious public health risks.

Advertising of pharmacy services must be accurate and must not mislead the public.

Complaints against pharmacists are investigated by the conduct committee; outcomes include caution, conditions, suspension, or removal.

Registration renewal requires evidence of continuing professional development and good standing.

Quality risk management (ICH Q9) uses tools such as FMEA, HACCP, and risk ranking to prioritise controls.

Corrective and preventive action (CAPA) requires root cause analysis, implementation, and effectiveness verification.

Supplier qualification includes audits, certificates of analysis, and quality agreements.

Technology transfer requires documented process knowledge, validation, and comparability assessment.

Recall procedures require a recall coordinator, communication plan, and effectiveness checks.

Complaint handling must be documented and investigated within defined timelines.

Training records must demonstrate competence for all personnel performing critical operations.

Annual product quality review summarises batch data, deviations, complaints, and changes to confirm process control.

Spectroscopic techniques: UV-Vis for quantitative assay; IR for identification; NMR for structure elucidation; MS for molecular mass.

Chromatographic techniques: HPLC for assay and impurities; GC for volatile compounds; TLC for qualitative screening.

Method validation parameters follow ICH Q2: accuracy, precision, specificity, linearity, range, LOD, LOQ, and robustness.

System suitability criteria are defined in the pharmacopoeia and must be met before sample analysis.

Reference standards and working standards must be traceable and stored under defined conditions.

Sample preparation must avoid contamination and degradation; extraction efficiency must be validated.

Data integrity: audit trails, access controls, and periodic review are required for electronic records.

Out-of-specification results require investigation and documentation before batch release.

Preformulation studies characterise solubility, polymorphism, particle size, flow, and compatibility.

Polymorphs differ in solubility and stability; the most stable form is preferred for development.

Solubility enhancement: salt formation, cocrystals, surfactants, cyclodextrins, and particle size reduction.

Bioavailability enhancement: lipid formulations, solid dispersions, and nanosuspensions.

Scale-up requires validation of mixing, granulation, compression, and coating parameters.

Process analytical technology (PAT) enables real-time monitoring and control.

Container closure systems must protect the product from moisture, light, and oxygen.

Stability studies must include accelerated and long-term conditions with appropriate testing intervals.

Pharmacokinetics: absorption, distribution, metabolism, and excretion determine drug concentration over time.

First-pass metabolism reduces oral bioavailability; routes avoiding it include IV, sublingual, and transdermal.

Protein binding affects distribution and clearance; only free drug is pharmacologically active.

Drug interactions: pharmacokinetic (absorption, distribution, metabolism, excretion) and pharmacodynamic (additive, synergistic, antagonistic).

Therapeutic drug monitoring is indicated for narrow therapeutic index drugs and for drugs with variable pharmacokinetics.

Adverse drug reaction reporting is mandatory for serious reactions; causality assessment uses WHO-UMC criteria.

Patient counselling improves adherence and outcomes; use plain language and teach-back methods.

Medication errors should be reported and analysed to improve systems.

The regulator maintains a public register of pharmacists and pharmacy premises.

Registration may be granted with conditions or restrictions.

Practitioners must notify the regulator of changes in contact details and practice status.

Professional indemnity insurance is a condition of practice in many jurisdictions.

The regulator may issue practice guidelines and codes of conduct.

Non-compliance may result in disciplinary action and penalties.

The Act provides for reciprocal recognition of qualifications under agreements.

Public protection is the primary objective of pharmacy regulation.

GMP requires a quality management system, personnel training, and documented procedures.

Premises must be designed to prevent cross-contamination and mix-ups.

Equipment must be qualified and calibrated; maintenance records must be kept.

Production documentation must be contemporaneous and traceable.

Quality control laboratories must be independent of production.

Batch records must be reviewed before release.

Deviation and change control systems must be in place.

Recall procedures must be tested periodically.

Acid–base titration curves show buffer regions and equivalence points.

Complexometric titration uses EDTA to chelate metal ions.

Redox titration uses oxidising or reducing agents; endpoints detected by indicators or potentiometry.

Non-aqueous titration is suitable for weak acids and bases.

Potentiometric titration provides accurate endpoint detection.

Spectrophotometric assays require blank correction and calibration.

Chromatographic assays require system suitability and validation.

Impurity profiling is essential for safety and quality.

Dosage form selection depends on patient factors, drug properties, and therapeutic needs.

Pediatric and geriatric patients may require liquid or dispersible formulations.

Modified-release forms improve adherence and reduce fluctuations.

Sterile products require aseptic technique and validation.

Packaging must protect the product and provide information.

Stability testing ensures shelf-life and storage conditions.

Quality by design improves robustness and reduces failures.

Process validation ensures consistent product quality.

Pharmacodynamics describes drug effects and mechanisms.

Pharmacokinetics describes drug disposition.

Dose–response relationships guide therapeutic dosing.

Therapeutic index indicates safety margin.

Adverse drug reactions must be monitored and reported.

Drug interactions must be assessed before prescribing.

Patient education improves adherence.

Clinical pharmacy services improve outcomes.

Pharmacists must maintain competence through continuing education.

Professional conduct standards apply to all registered practitioners.

Confidentiality is a core ethical duty.

Informed consent is required for pharmaceutical care interventions.

Record-keeping supports continuity of care and accountability.

Reporting obligations include adverse reactions and errors.

Regulatory inspections ensure compliance.

Public safety is the overarching goal.

Regulatory submissions require complete and accurate data.

Good review practices ensure timely and consistent assessments.

Post-marketing surveillance identifies rare adverse effects.

Risk management plans mitigate identified risks.

Labeling must be clear and accurate.

Advertising must comply with regulations.

Inspections verify compliance with standards.

Enforcement actions address non-compliance.

Analytical methods must be validated for intended use.

Reference standards ensure accuracy and traceability.

Quality control testing confirms compliance with specifications.

Stability-indicating methods detect degradation.

Impurity limits protect patient safety.

Data integrity ensures reliable results.

Instrument calibration maintains accuracy.

Documentation supports traceability.

Formulation development balances efficacy, safety, and stability.

Excipients must be compatible with the drug.

Manufacturing processes must be validated.

Quality control tests confirm product quality.

Packaging protects the product.

Storage conditions affect stability.

Patient acceptability influences dosage form choice.

Scale-up must maintain product quality.

Drug therapy must be individualised.

Monitoring ensures efficacy and safety.

Adherence is essential for outcomes.

Patient counselling improves understanding.

Adverse effects must be managed promptly.

Drug interactions must be avoided or managed.

Therapeutic guidelines inform practice.

Evidence-based practice improves outcomes.

Registration is required to practise pharmacy.

Licensing is required for pharmacy premises.

Inspections ensure compliance.

Disciplinary actions protect the public.

Appeals processes ensure fairness.

Continuing education maintains competence.

Professional indemnity insurance protects patients and practitioners.

Public protection is the primary objective.