VOCABULARY

SESSION 1:
- BP (Blood Pressure): force exerted – blood vessels – vital sign – force applied
- c/o (complains of): describes symptoms (painful, uncomfortable)
- Dx (Diagnosis): positive identification – disease, ailment, illness
- HR (Heart Rate): frequency – heart beats – number of heartbeats
- HTN (Hypertension): blood pressure – higher – high blood pressure
- o/e (on examination): discovered – exam – investigating
- Rx (Treatment, Prescription): to treat – medical condition – infection + antibiotics
- SOB (Shortness of Breath): difficult to breathe – asthmatic – labored breathing
- T (Temperature): quantitative – heat – vital sign – body heat
- WNL (Within Normal Limits): normal range – average level
- XR (X-ray): electromagnetic radiation – see bones, internal aspects
- Physician: Doctor
- vital sign: T – HR – BP – Respiration
- cc (cubic centimeter): cube – equal to one centimeter – one milliliter
- drop (gtt): liquid – dropper – 1/12th of a milliliter
- gtt: drops – eye
- gram (g): one thousandth of a kilogram
- milligram (mg): one thousandth of a gram
- microgram (mcg): one millionth of a gram
- milliequivalent (mEq): 1/1000th the weight – chemical – component
- milliliter (ml): one thousandth of a liter – one cubic centimeter
- ounce (oz): 1/16th of a pound
- Tablespoonful (Tbsp): standard tablespoon – three teaspoons (15 ml)
- teaspoonful (tsp): standard teaspoon – five milliliters
- administer: give medicine
- route of administration: path by – medicine – into the body
- dosage: correct – amount – frequency
- I.V (intravenous injection): into a vein – long period of time – serious dehydration (fluids)
- I.M (intramuscular injection): into a muscle – dosage of steroids
- SQ/SC (subcutaneous): fatty layer – under the skin
- P.O (by mouth): orally – through the mouth – pills
- P.R (per rectum): through the rectum
- SL (sublingually): beneath the tongue – pills
- Topical: surface of the body – ointment – affected area
SESSION 2:
- ac: before meals – before someone eats
- pc: after meals – after someone eats – after eating
- BID: twice per day
- TID: three times per day
- QID: four times per day
- QOD: every other day - hydrocortisone
- qh: every hour
- qhs: at bedtime – when you go to bed
- PRN: as needed – for pain (ibuprofen)
- stat: immediately – immediate attension – heart attack
- allergy: medical condition – a reaction – comes in contact – substance – exposing
- complaint: pain – illness – reported (patient)
- current: present time – recent injury
- data: collection – information
- family medical history: record – medical conditions – patient’s family – hypertension,
diabetes, cancer
- history of: experienced – regularly – repeatedly – cancer
- onset: start – first instance
- past medical history (PMH): record – previous illnesses – previous surgeries
- proceduce: medical treatment – doctor – surgeon
- social history: record – lifestyle – habit – occupation – marital status
- on and off for years: comes and goes
- cold: coughing – runny nose – sore throat – illness – discomfort in head and body
- cough: force air – loudly through throat
- fever: body temperature – rise - thermometer
- flu: viral illness – fever – ache – wheezing – coughing – fatigue
- headache: pain – head
- muscle ache: pain – muscles – throughout the body
- runny: liquid flowing – leaking out
- symptom: feeling – physical change – indicates illness
- throb: pain – comes and goes – quickly – the pain in back
- wheeze: breathe with difficulty – noisy - noisily
- analgesic: over-the-counter drug (OTC drug) – relieve pain – reduce the fever
- severe: critical – extreme >< minor – mild
SESSION 3:
- affect: bring about a change – mood – made a difference upon
- body language: conveyance of information – moves
- evaluate: determine the qualities
- inspection: examination – physiological state – investigation
- observation: notices – noticing – watching carefully – limping – body language
- auscultation: exam by listening – stethoscope
- palpation: exam by touch – arms, legs, back, neck
- percussion: tapping on – determine condition underlying bone or tissues – organs beneath
the abdomen – internal organs – excess abdominal fluid
- pulse: heartbeats – period of time
- vital signs: essential body functions – temperature (taking temperature), pulse rate
(checking pulse), blood pressure, respiration (auscultation)
- patient – comfortable
- environment – optimal
- techniques: examination – auscultation, palpation, percussion
- albumin: protein – in the body
- biopsy: piece of tissue – removed – examined
- blood pressure: pressure – blood moves
- BUN test (Blood Urea Nitrogen test): urea nitrogen in the blood
- CKD (Chronic Kidney Disease): medical condition – loses kidney function over time
- creatinine: waste product in blood – kidney removes
- GFR test (Glomerular Filtration Rate): determine – kidney function – how well kidneys are
working
- pathology report: report – cells and tissue were examined – results from several tests
- renal: related to kidneys – renal failure = kidney failure
- urinalysis: examines urine sample
- urine: yellow liquid waste product
- kidney – just one – normal life
- disease: urine contains high levels of albumin – blood contains high BUN level
- CT scan: medical imaging – two-dimensional X-rays – three-dimensional image
- ECG (Electrocardiogram): electrical activity of the heart – abnormal heart activity
- MRI (Magnetic Resonance Imaging): medical imaging technique – uses magnetic
- x-ray: from of radiation – take pictures – internal body – broken born
- ultrasound: reflection – sound waves – pregnant woman – unborn children
- endoscope: thin, tubular instrument – examine inside organ – body cavity –
instrument/equipment
- endoscopy: method
- feed: an endoscopic tube – insert into
- gel: semi-solid – applies before ultrasound – apply
- medical imaging: process of creating picture – diagnosing, treating – modern technology
- radiography: use – x-ray to view images
- advanced medical imaging: CT scan, ECG, MRI, ultrasound
- non-advanced medical imaging: X-ray
SESSION 4:
- Production department: compound raw materials, package, leaflets – keep careful records
- Research & Development (R&D): find new substances – make new drug formulations –
change existing dosage forms
- Regulatory Affairs (RA): compile – drug documentation – send – authorities – get –
authorization – market
- Marketing and Sales: plan – promotion – distribution – launch – make decision –
packaging/colour
- Clinical Affairs (CA): test – organize testing – on live subjects – safe – effective
- Quality assurance (QA): ensure – meet standards – contain the active ingredients advertised
- prescription drug: medicine – pharmacy – requiring a written note from the doctor
- over-the-counter drug (OTC drug): sold without the patient seeing a doctor
- dosage form: final form of the medicine
- launch: sell
- feasibility study: investigation – advantages, practicality, profitability
- products in the pipeline: future frugs – not on the market
- the main reason (goal) I am writing to you today is to remind you…
- here is an update on the project: newest information about project
- as you know, it will be a prescription drug, so…
- you are probably aware that…
- as far as Marketing is concerned,…
- Pharmacovigilance manager: collect – drug safety information – on our medications –
report – serious adverse events
- Clinical research associate: test drugs on live subjects – work closely – doctors – make sure
– studies correctly
- Laboratory technician: operate – complex scientific instruments – perform tests –
ingredients – meet requirements
- Medical writer: research, write and edit – clinical, study reports – summarize and interpret
clinical data
- Project manager: co-ordinate (coordinate) – cross-functional teams – meet deadlines
- Qualified person: responsible for quality – production line – Standard Operating
Procedures (SOPs)
- Packaging technician: make sure – suitable, clean containers – compliance with health
regulations
- Formulation scientist: develop pharmaceutical dosage forms – tablet formulation –
ointment – gel forms
- on our medication: taking our medicine
- ingredients: a substance in drug
- Standard Operating Procedures (SOPs): description – working method – process
- subjects: human – animal drugs – tested on
- adverse event: any health problem – starts – on a new medicine
- Health regulations: rules – laws about health
- ointment: oily substance like cream
- REPORT serious adverse events TO heath authorities
- TESTED ON live subjects
- OPERATE complex scientific instruments
- DETERMINE – meet requirements
- PERFORM clinicial trials
- summarize, INTERPRET
- SUBMIT documents TO regulatory authorities
- DEVELOP pharmaceutical dosage forms
- I’ve been with the company for about three months now
- I am American, but originally I come from Vietnam
- I am based at our manufacturing plant in Shanghai: work at
- My professional background is in pharmacology
- I got/received/obtained my master’s degree at New York University
- The first scientific degree future pharmacists obtain – bachelor’s degree
- After receiving BS – continue studies – several more years – get master’s degree – involves
research
- Before – become full qualified – pharmacists have to take an examination – get licence to
practise pharmacy
- After MS – go on to do a doctorate
- Bachelor’s degree (BS)/ bachelor of science degree (BSc)
- Master’s degree (MS)/ master of science degree (MSc)
- Licence (UK)/license (US) to practise pharmacy
- Doctorate or Doctor of philosophy degree in pharmacy (PhD) Doctorate
- To do list: at the end of meeting – the results of the meeting are often summarized in
writing as action points
- I used to work at Johnson…
- I worked for … and later for …
- I first started as … and worked my way up to …
- I did research on clinical methodology
- I have experience in …, so that is why…
- I was on the team that …
- I was involved in …
- I am the … assigned to this project
- I am responsible for …
- I am supported by …
- We are currently working on …
- At the moment, I am working on a project to …
- Before we close, I’d like to review the action points
- … will be looking after …
- … is going to find/look at…
- … is to finish…by the end of the…
- … needs to get back to me by …
- (company) is searching for a (position)
- …will assist…
- …be resposible for…
- …will need to be able to…
- … is essential to this job…
- at a minimum…is required, … is preferable
- …should/must have at least … years’ experience in …
- PTA: Pharmaceutical Technical Assistant – Pharmaceutical technician/Pharmaceutical
laboratory technician (better)
- Junior scientist – Scientist 1 (recent university graduate)
- Senior scientist – Scientist 2,3 (more experienced colleague)
- Associate – Partner
- Production pharmaceutical professions: Line worker
- Non-production pharmaceutical professions: Clinical research associate – Formulation
scientist – Laboratory technician – Pharmacovigilance manager
- Dosage form: capsules – gel – ointment – sugar-coated tablets
- What goes into drugs: chemicals – ingredient – raw materials – substances
- Pharmaceutical documentation: Clinical report – Dossiers – Protocols – Study reports
- We plan to launch all of these products in Europe first and to apply for food and drug
administration (FDA) approval in the US the following year
- Since the conclusion of our successful feasibility study, we have also obtained very
encouraging preclinical data (= end)
- Since the conclusion of our successful feasibility study, we have also obtained very
encouraging preclinical data
- A(n) memo is a short official note that is sent by one person to another within the same
company or organization
- Project members from Marketing, Production, and Clinical Affairs are already on board
- Preclinical data is the information about a medication that is assessed before clinical trials
- Feasibility study is an investigation to determine the advantages, practicality, and
profitability of a proposed project
- deadline a date or time by which you have to do or complete something
- I collect drug safety information about patients on our medication
- Health regulations are rules or laws about health
- Formulation scientists develop pharmaceutical dosage forms
- I am the clinical trial manager assigned to this project and am supported by two clinical
research associates who will work with test centres in northern Italy and in Slovenia
- By the end of the meeting I hope we will have come up with deliverables for getting the
project off the ground and a full to do list
- Before they become fully qualified, pharmacists in the US have to take an examination to
get a licence to practise pharmacy
- I did research on clinical methodology
- Charley is to describe the technical equipment needed with a cost estimate by the end of the
month
- With your input, I'll be able to finalize the timelines for planning and implementation and
decide on milestones before our next meeting
- With your input, I'll be able to finalize the timelines for planning and implementation and
decide on milestone (s) before our next meeting
- You need to be able to write scientifically and technically accurate protocols in English
- clinical research organization (CRO) is an organization that provides support to the
pharmaceutical, biotechnology, and medical device industries in the form of research
services outsourced on a contract basis
- Unlike in many countries, you'll also find many cheerful, bright coloured ads in magazines,
which promote anti-depressants and other prescription drugs in the US
- In Europe, the strength of medicine varies considerably depending on what health
authorities allow
- In Russia, we prefer to buy over-the-counter products, like cold remedies or cough syrup,
from people in pharmacies wearing white lab coats
- Cross-cultural means involving two or more different cultures
- Some companies are successful at marketing their drugs all over the world without making
any major changes to them. Others have different formulations, advertising, and packaging
in each country, due to differences in custom (s) and laws
- Quality is important all over the world, but in Japan we take it one step further. We will
reject a whole shipment of drugs if we find the smallest scratch or imperfection in one single
package, even if it makes no difference to the product at all
- A Subsidiary is a company which is part of a larger and more important company
SESSION 5:
- Research: process testing chemical compounds – finding a substance – beneficial effect –
targeted disease – research & discovery (2-5 years)
- Development: process – carry forward – marketable drug – preclinical development –
clinical trials – approval & product launch (6-12 years)
- Clinical trials (long time): Phase 1: Safety, dose and how it works in volunteers – Phase 2:
Dose it work in patients? – Phase 3: Getting evidence in larger population – Phase 4:
Continuous monitoring and maintaining safety oversight
- Clinical trial: is a scientific study designed to systematically test a medical intervention in
humans
- In the fields of medicine, biotechnology and pharmacology, drug discovery is the process
by which new candidate medications are discovered
- Factors help pharmaceutical companies decide what drugs thay should develop: Time –
Cost – Profitability – Risk of failure – Chance of success – Technology
*Research and development project manager:
- Research: analysis of disease – discovery – new chemical entities (NCE) – target
identification
- Development: analytical testing – clinical trials – dosage form – drug safety
- Research: Pharmacologist – Biologist – Chemist
- Discovery Preclinical development: Pharmacologist – Toxicologist – Laboratoty technician
– Formulation scientist
- Clinical trials (1, 2, 3, 4): Regulatory Affairs – Medical writer
- Phase 1, 2, 3 trials: Clinical research associate
- Phase 4 trial Drug approval: Production – Packaging technician – Sales & marketing –
Quality assurance – Qualified person – Pharmacovigilance manager
*
- Scientists have made a major breakthrough in the treatment of cancer
- New chemical entities (NCE): breakthrough – just been synthesized
- New chemical entity: is a unique, pharmacologically active product that has never
previously been synthesized or used to treat disease
- Obtainable with physician’s prescription only
- Chemist: specialist or expert – chemistry – US: pharmacist
- Dose: is the amount of substance given at one time.
- Dosage: is the amount and frequency of a medicinal drug that may be taken safely
- Dosage form: is the final form of the medicine, e.g. Tablet, powder, gel, spray, etc – using
the right – giving medicine to children – problems swallowing pills
- Toxicology: is the study of poisons – sourse, chemical composition, action, tests – antidotes
- Toxicologist: is an expert in the science of poisons
- Toxicity: is the degree to which a substance (a toxin or poison) can harm humans or
animals
- Route of administration: is the path by which a drug, fluid, poison, or other substance is
taken into the body
- Prescription: from physician – obtain from pharmacy – not available over-the-counter
- Mensamint is a new dosage form of Mensadent. Known side effects often include loss of
sleep if taken in the late afternoon or evening. Occasionally (now and then ), an increase in
blood pressure may occur
- Formulation: is a mixture of ingredients prepared in a certain way and used for a specific
purpose – chemists – pharmacologists – interested in how the medicine is administered
- First in-man study: is Phase-1 study in which a test product is administered to human
beings – tested on human beings – stage I study
- Pharmacology: study drug – how they work – what they do in the body - can be divided
into two separate areas: Pharmacodynamics and Pharmacokinetics
- Chemists and Pharmacologist are also interested in how the medicine is administered, so
they often ask about its formulation
- Pharmacokinetics: is the study of the bodily absorption, distribution, metabolism, and
excretion of drugs (what the body does to the drug)
- Pharmacodynamics: is the study of physiological effects of drugs and the mechanisms of
their actions (what the drug does to the body)
- What kind of formulation could we develop: lozenge – chewing gum form – patch
- What about the bioavailability of this NCE: bioavailability – non-intravenous routes of
drug administration
- Bioavailability: is the proportion of a drug or other substance which enters the circulation
when introduced into the body and so is able to have an active effect
- What is the toxicity of this NCE: harmful side effects
- When substances are taken with alcohol or antibiotics, their chemical form could change
and even cause harmful side effects
- Do we have the technology to make patches: a partner to help us develop a patch form
- When can we start the first in-man study: take a year – first tests on healthy humans
- When you chew food, you use your teeth to break it up in your mouth so that it becomes
easier to swallow
- Ask opinion: What do you think about – What’s your opinion on – What’s your view of
- Give opinion: I feel – In my opinion, – From my point of view,
- Give strong opinion: I firmly believe – I feel very strongly that – I’m convinced
- Avoid (no comment): I would rather not say – I’m sorry I cannot comment on – I’m afraid I
am not in a position to
- Route of administration: Oral – Topical – Rectal – Parenteral (veins) – Vaginal – Inhaled –
Ophthalmic (eyes) – Otic (ears)
- Physical form: Solid – Semisolid – Liquid – Gaseous
- Some medications are available in liquid form, such drops or syrup
- Tablet: is a hard, compressed medication in round, oval or square shape
- Pill: is a small, round piece of medicine to be swallowed without chewing
- Chewable tablet: is chewed prior to swallowing. It is designed for administration to
children e.g. vitamin products
- Sublingual tablet: is administered by placing it under the tongue
- Lozenge: is a solid preparation that is intended to dissolve or disintegrate slowly in the
mouth (e.g.. Sore throat)
- Effervescent tablet: is an uncoated tablet containing substances that react in the presence of
water and give off carbon dioxide
- Hard gelatin capsule: is a type of capsule that is usually used to contain medicine in the
form of dry powder or very small pellets
- Soft gelatin capsule: is a type of capsule that is usually used to contain oils and for active
ingredients that are dissolved or suspended in oil
- Oral solution: is a liquid in which another substance has been dissolved
- Oral drops: are liquid preparations for oral use that are intended to be administered in small
amount with the aid of a suitable measuring device
- Syrup: is a sweet, liquid medicine taken with a spoon or cup
- Oral dosage form: Tablet – pill – chewable tablet – sublingual tablet – lozenge –
effervescent tablet – hard/soft gelatin capsule – oral solution – oral drops – syrup
- Aerosol: is a dosage form that is packaged under pressure and contains therapeutically
active ingredients that are released upon activation of an appropriate valve system
- Inhaler: is a small device with medicine to breathe in through the mouth
- An inhaler is an aerosol dispensing device which releases medication into the mouth of the
patient
- Inhaled dosage forms: are breathed in through mouth or nose and are often used to treat
respiratory diseases – aerosol – inhaler
- Aerosol (device): is a container with a liquid that is administered in spray form
- Patch: is a medication on material or cloth placed on the skin
- Liniment: is an oily liquid to rub on painful body parts to reduce pain
- Lotions: are fluid preparations (aqueous) for external application without friction
- Creams: are semi-solid emulsion – mixtures of oil and water
- Ointment: are semi-solid, smooth greasy preparations for application to the skin for healing
- Gel: is a drug delivery system consisting of a semi-solid, jelly-like substance
- Topical dosage forms: aerosol – patch – liniment – lotions – creams – ointment – gel
- Nasal spray: is a substance dispensed as a fine spray from a container into the nostril
- Eye drops: are a kind of medicine that you put in your eyes one drop at a time
- Suppository: is a solid medicine which melts slowly in the rectum or vagina
- Time-release delivery: means a drug preparation that gradually releases an active substance
over a period of time
- calculating the correct dosage for
- trouble swallowing large pills or tables
- wearing a patch – skin allergies
- suppository – to babies – not able to take drugs orally
- drops: very small amount of liquid – a round shape
- patch: cloth placed on the skin
- An ailment is an illness, especially one that is not very serious
- Allergic reaction: is the body's exaggerated immune response to an internal or surface agent
- anaemia: is a medical condition in which there are too few red cells in your blood, causing
you to feel tired and look pale
- Asthma: is a lung condition which causes difficulty in breathing
- Bronchitis: is the inflammation of the bronchial tubes, characterized by coughing, difficulty
in breathing
- A chronic illness or disability lasts for a very long time. Opposite to acute
- Diabetes: refers to a group of diseases that affect how your body uses blood sugar (glucose)
- Diarrhoea: is a condition in which faeces are discharged from the bowels frequently and in
a liquid form
- Dizziness
- If you have a fever when you are ill, your body temperature is higher than usual
- If you have indigestion , you have pains in your stomach and chest that are caused by
difficulties in digesting food
- An inpatient is someone who stays in a hospital while they receive their treatment
- Someone who suffers from insomnia finds it difficult to sleep
- Nausea is the condition of feeling sick and the feeling that you are going to vomit
- Pneumonia is the inflammation of the lungs. The lungs become filled with liquid which
makes it difficult to breathe
- If a wound or a part of your body becomes septic, it becomes infected
- Skin rash
- Vomiting
- Over-the-counter drug: is a product which can be sold without the patient seeing a doctor
- Prescription drugs: the medicine bought in pharmacy and requiring a written note from the
doctor
- Behind-the-counter: can be purchased without a prescription but only with the personal
involvement of a pharmacist
- US: OTC drug & Prescription drug (2 drug categories)
- UK, Canada: OTC drug, BTC drug & Prescription drug (3 drug categories)
- Medicine needs to be easily accessible. This is, of course, a question of public health. On
the other hand, these same products can do harm if used incorrectly. This danger must be
avoided
- Four criteria – non-prescription (OTC) drug: large margin of safety – low incidence of side
effects – low potential for drug abuse – adequate directions for sale and effective use
- Medication must meet four criteria in order to obtain the status of a non-prescription or
OTC. It must have: a large margin of safety, low incidence of side effects, low potential for
misue and abuse, and labelling that provides adequate directions for sale and effective use
- At present, the Food and Drug Administration is reviewing its current policy on the number
of categories of medicines
SESSION 6:
- GxP: abbreviation for good practice – required by international regulatory Authorities
- GAP: stands for Good Auditing Practice
- GCP: stands for Good Clinical Practice
- GDP: stands for Good Documentation Practice
- GLP: stands for Good Laboratory Practice
- GMP: stands for Good Manufacturing Practice
- GRP: stands for Good Research Practice
- GSP: stands for Good Safety Practice
- Quality assurance (QA): involves all manufacturing processes in GMP which make sure the
goods produced are kept at high standards and standard operating procedures (SOPs) are
followed – includes: quality control, sampling and testing
- The quality assurance process in Good Manufacturing Practice (GMP) includes product
quality control, sampling, and testing
- Quality control: involves interim testing and product sampling procedures, which are
carried out to check product quality
- The reason for interim testing, or product sampling, is to check the quality of
pharmaceutical products
- Endpoint testing: is carried out at the end of every manufacturing process to ensure that all
procedures have been performed in compliance with industry and company standards – At
the end of every stage of a product's manufacturing process, endpoint testing is done to
maintain quality standards
- Documentation: is important and necessary at every step of the processes, activities, and
operations involved in drug manufacturing because: prevent product contamination – enable
traceability => full product recall
- Contamination: A few years ago, a well-known European pharmaceutical company was
forced to recall one of its drugs due to claims of product contamination
- The documentation required for all research processes and development steps ensures the
traceability of a drug
- Internal audit: involes inspection and validation of operational methods, procedures,
equipment to ensure functionality, accuracy and validity
- Inspection and validation are required to prove that the manufacturing and testing
equipment is functional
- All operational methods and procedures must also be inspected for accuracy
- Beyond the filed of manufacturing, good practice must be adhered to in all processes in a
pharmaceutical company
- A holistic approach looks at all aspects of a pharmaceutical company together to make sure
that the entire process meets high industry standards – consider laboratory and
manufacturing processes and environments together and not individually
- Standard operating procedures (SOPs) are written and used by companies to make it easier
for them to follow GxP These are a set of written instructions to maintain performance and
results
- Product sampling carried out: check product quality – make sure SOPs are followed – meet
high industry standards
- Operational methods and procedures have to be validated: complete the quality assurance
process – make sure product perform their intended function – complete the inspection
process
- Aspect of drug manufacturing enables traceability: Quality assurance – Quality control –
Documentation
- Contaminated products are no longer pure and acceptable for sale or public use and,
therefore, must be returned to the manufacturer, or destroyed
- Even a product that has been marketed for years might have to be taken off the market in a
product recall if serious adverse reactions occur
- Manufacturing processes and procedures must go through periodic validation to guarantee
that they are still of an acceptable standard
- Audit finding: compliance – non-compliance
- If any non-compliance is observed during the audit, the department will be informed so
they can take corrective action – critical – major – minor
- An annual audit of safety procedures in all laboratories is carried out yearly
- Corrective Action/Preventive Action (CAPA): Part of Quality Management System (QMS)
– Systematic investigation of errors or deviations
- Preventive Action (PA): prevent occurrence of errors
- Corrective Action (CA): prevent recurrence of errors
- Corrective action / Preventive action ( CAPA ) is a part of the overall Quality Management
System ( QMS) required for GMP - It focuses on the systematic investigation of non-
conformance events (errors or deviations), to prevent their occurrence (for preventive action)
or recurrence (for corrective action)
- Quality Management System (QMS) is a formalized system that documents processes,
procedures, and responsibilities for achieving quality policies and objectives
- proper documentation not only enables traceability, but also allows a complete product
recall from the market, if necessary
- Standard operating procedures (SOPs) are a set of written instructions to maintain
performance and results. They are the basis of good QA and QC system
- Please make sure that – in accordance with (should be done)
- This memo is to advise you that (the reason for)
- will be reviewed with (will be audited)
- department is scheduled for (department is involved)
- the timetable for … is as follow (planned schedule)
- Please send us a copy of (have a copy)
- Please confirm receipt (verification of information) of this memo and send us a copy of all
your correspondence with regard to this scheduled audit
- advance notice: of this meeting was very short
- Safety procedures: make sure that the health and well-being of laboratory workers are
guaranteed
- Auditors generally watch or observe safety procedures in the lab
- An auditor inspects and verifies the safety procedures in the lab
- To ensure that laboratory workers are asked certain questions about safety procedures,
auditors use a checklist
- Scientists often read journals and go to international conferences, because they need to stay
up-to-date in their scientific fields
- Standard operating procedures (SOPs) are updated on a regular basis, often after an audit
has been carried out
- Any observation or finding noted by the auditors is categorized as either major, minor, or
critical
- We should tell the lab staff to double-check that all the labs are spotlessly clean and that all
lab devices and equipment are where they should be - at every single workstation
- Non-compliance areas: improper clothing/safety equipment (safety gloves too big, no
safety goggles) – improper hygiene after handling animals (hand-washing or sanitizing
forgotten) – improper documentation (no recording of experiment times) – improper
transportation of lab animals (lab mice moved outdoors in open cages) – improper disposal
of toxic waste (chemicals found in normal waste bins)
- Neutral: I suggest – My suggestion – My recommendation – It might be possible
- Strong: I strongly suggest – The only solution is – I’m convinced – It is absolutely essential
- chemicals found in normal waste bins: I suggest you dispose the toxic chemicals in the
correct waste bins
- lab mice moved outdoors in open cages: It is absolutely essential to move lab mice
outdoors in closed cages
- safety gloves too big, no safety goggles: The only solution is to make sure safety gloves are
available in all sizes and that all lab staff use safety goggles in future
- no recording of experiment times: My recommendation is to review with all lab staff the
procedures for recording experiments
- hand-washing or sanitizing forgotten: I strongly suggest that all staff comply with the
proper rules for hand-washing and sanitizing in future
- Eye bath: is a/an apparatus to wash the eyes after exposure to chemical contamination
- Gas mask is a device that you wear over your face in order to protect yourself from
poisonous gases
- Safety glasses/goggles: Protective glasses/goggles must be worn at all times in the
laboratory
- Overshoes are shoe covers used to reduce foot borne contamination and help maintain a
sterile environment
- Fire blanket is a safety device consists of a sheet of a fire retardant material which is placed
over a fire in order to extinguish it
- All toxic waste materials must be disposed of properly
- Good sanitary hygiene must be practised by all lab staff
- Protective clothing must be worn in the labs at all times
- Lab animals must be transported in covered cages
- Eye protection must be worn as signposted
- All work with virus- infected animals must be performed in the bio-safety cabinet
- Small biological agent spills must be covered with a paper towel and treated with bleach
- disinfectant must be used on all equipment following any experiments with laboratory
animals
- To clarify something means to make it easier to understand, usually by explaining it in
more detail
- You need to disinfect all equipment following any experiments with laboratory animals
- I suggest you dispose of toxic waste in the bins provided for this purpose
- All laboratory work must be documented in accordance with GLP
- Proper protective clothing and safety equipment must be worn at all times
- Disinfectant must be used on all equipment following an experiment with laboratory
animals
- Toxic or hazardous materials must be disposed of properly
- Validation of cleaning processes is essential in this industry, because chemical or bacterial
contamination of drug products can potentially lead to severe public health risks
- According to reports, it seems that an unanticipated reaction between the drug's active
ingredient and the chemicals used as part of the cleaning processes at the site was the cause
of the contamination
- A few years ago, a well-known European pharmaceutical company was forced to recall one
of its drugs due to claims of product contamination
- A product recall took place following reports from patients that their medication had a
strange odour. Several patients from a number of different countries made the complaint
within a short period of time
- Special containers are provided for the disposal of toxic waste materials
- The company claims that a cleaning error was the reason for the entire incident. This
clearly underlines the danger of underestimating the importance of the cleaning process in
pharmaceutical manufacturing
- Genotoxic substance is a chemical that damages cellular DNA, resulting in mutations or
cancer
- A few years ago, a well-known European pharmaceutical company was forced to recall one
of its drugs due to claims of product contamination. The drug manufacturer was unable to
say just how many patients were taking this drug at the time. However, it estimated the
global figure at over 40,000 people
- Odour is a distinctive unpleasant smell
Câu hỏi kiểm tra:
If a medicine is SQ, it is injected into the fatty layer under the skin with a syringe
Which of the following is NOT a vital sign => XR
To administer medicine is to give it to a patient
The patient's blood sugar levels are WNL
Nurse: This note calls for three gtt in each eye twice a day. That seems a little high
Doctors said that Christine's BP is very high. They’re keeping her for observation until it
gets down to about 130/70
Dx is the positive identification of a patient’s disease or ailment
If a function is WNL, it is operating in a normal range
How should we administer Mr. Smith’s medicine
I have a fear of swallowing pills and for that reason my doctor always prescribes pills that
can be absorbed sublingually
The veterinarian has requested you fill a prescription and explain the dosing to the owner.
The prescription instructions read, "Vancomycin 1500 mg IV BID for 3 days"
What is the correct interpretation? => Give Vancomycin 1500 milligrams intravenously
twice a day for three days
The directions to create an oral suspension for your patient read, "Mix 1 mcg in 5 mL H20
and give 0.3 mL PO pc."
What protocol is used for mixing and how should this medication be given? => Mix 1
microgram in 5 milliliters water and give 0.3 milliliters by mouth after meals
I've told the nurses to give the patient his medicine every day ac so that his body will digest
it easily
This could be hereditary so we'll need to look at your family history
Can you tell me what you were doing at the onset of the symptoms?
Before doing any procedure we must first know about any allergies or previous conditions
Mary's symptoms suggest that she has got the flu and not a cold
The patient's pre-existing condition was caused by a past injury
Mr. Brinks might need a mild sedative to sleep, so give him some Sommel qhs
From the notes, it seems the onset of symptoms started after moving house
Choose the INCORRECT statement: => A social history is a record of the medical
conditions of a patient's family that might affect the patient's health
The veterinarian has requested you fill a prescription and explain the dosing to the owner.
The prescription instructions read, "1-tab P.O. QID for 7 days, then BID PRN."
What is the correct interpretation? => Give 1 tablet by mouth every 6 hours for 7 days, then
every 12 hours as needed
Choose the CORRECT statement: => A fever is an illness that causes body temperature to
rise
The directions to create an oral suspension for your patient read, "Mix 1 g in 5 mL H20 and
give 0.3 mL PO ac."
What protocol is used for mixing and how should this medication be given? => Mix 1 gram
in 5 milliliters water and give 0.3 milliliters by mouth before meals.
What would be the appropriate interpretation for the following order?
"Demerol 50 mg IM stat"
Administer: Demerol 50 mg IM immediately
What would be the appropriate interpretation for the following order?
"Demerol 50 mg IM PRN"
Administer: Demerol 50 mg IM when needed
The veterinarian has requested you fill a prescription and explain the dosing to the owner.
The prescription instructions read, "1-tab SL TID for 7 days, then BID PRN."
What is the correct interpretation? => Give 1 tablet under the tongue three times a day for 7
days, then twice daily as needed
Choose the CORRECT statement: => A runny nose is one of the most common symptoms of
a cold
The directions to create an oral suspension for your patient read, "Mix 1 g in 5 mL H20 and
give 0.3 mL PO pc."
What protocol is used for mixing and how should this medication be given? => Mix 1 gram
in 5 milliliters water and give 0.3 milliliters by mouth after meals
Is there any connection between your past medical history and the current condition?
Choose the correct statement: => Electrocardiogram is a measurement of the electrical
activity of the heart over a period of time
An MRI uses magnetic forces of atoms to produce an image of the body.
X-rays and CT scans use radiography to take pictures, while ultrasounds use the reflection of
sound waves
Gel is a semi-solid substance placed between the patient’s skin and an ultrasound probe
Choose the CORRECT statement: => Auscultation is the examination of something by
listening with or without an instrument such as a stethoscope
You may feel some slight discomfort when the doctor first feed (s) the tube into the opening
Choose the Incorrect statement: => An ultrasound is a medical imaging technique that uses
the reflection of X-rays to produce an image of the body
We were taught percussion techniques to examine the organs beneath the abdomen.
The results show a high level of albumin in the urine
A(n) GFR test will determine a person’s kidney function
Subject is a human or animal drugs are tested on
The Quality Assurance (QA) department ensures that products meet the standards which the
law requires, and contain the active ingredients advertised
I was involved in the initial conceptual design phase
Over-the-counter drug is a product which can be sold without the patient seeing a doctor
Whereas a recent university graduate may start as a junior scientist, the more experienced
colleague would be a senior scientist
Dosage form is the final form of the medicine, e.g. Tablet, powder, gel, spray, etc.
A packaging technician's job is to make sure that suitable, clean containers are used to get
the product from the company to the patient
powder is a dry substance in the form of very small grains
Adverse event is any health problem which starts while on a new medicine
A packaging technician makes sure that suitable, clean containers are used to get the product
from the company to the patient
Laboratory technicians (1)________ complex scientific instruments and (2)________
whether liquids, powders, or tablets meet requirements => (1)operate/ (2)determine
A(n) laboratory technician operates complex scientific instruments and performs tests to
determine whether ingredients in liquids, powders, or tablets meet requirements
In Russia, we prefer to buy over-the-counter products, like cold remedies or cough syrup,
from people in pharmacies wearing white lab coats
A project manager coordinates and manages the cross-functional teams that develop and
launch a drug
The Clinical Affairs department is responsible for testing or organizing testing on live
subjects, and makes sure that the drugs are safe and effective for the patients
analgesic is a medication to reduce or eliminate pain
A laboratory technician operates complex scientific instruments and performs tests to
determine whether ingredients in liquids, powders, or tablets meet requirements
The Quality Assurance (QA) department ensures that products meet the standards which the
law requires, and contain the active ingredients advertised
Choose the term that does not fit in the category “non-production pharmaceutical
professions" => line worker
Standard operating procedures (SOPs) means a description of a working method or process

1. … is a quantitative measurement of heat within the body. It is can be used, in part, to

gauge whether the body is operating normally – T
2. If a medicine is ______, it is applied to a certain part of the surface of the body –
topical
3. Which of the following is equal to one ml – 1 cubic centimeter
4. Choose the word that matches the following definition "applied to a certain part of the
surface of the body" – topical
5. If a function is ______, it is operating in a normal range – WNL
6. ______ is the specific drug or course of action prescribed to treat a patient’s medical
condition – Rx
7. A(n)______ is a method of administering medicine into a vein using a syringe, often
over a long period of time – IV
8. T: 100.6 degrees Fahrenheit
9. A(n) ______ is a unit of mass which is equal to one-thousandth of a kilogram - g
10. We will have to increase the ______ because the infection is not clearing up – dosage
11.The directions to create an oral suspension for your patient read, "Mix 1 mcg in 5 mL
H20 and give 0.3 mL PO pc."
What protocol is used for mixing and how should this medication be given?
- Mix 1 microgram in 5 milliliters water and give 0.3 milliliters by mouth after meals.
12.Quick, give her an adrenaline injection ______, we are losing her! – stat
13.To cough is to force air loudly through the _____ . - throat because of an illness or
throat irritation
14.It says here the patient's ______ is headaches and dizziness. – complaint
15.The patient's ______ condition was caused by a past injury. – pre-existing
16.A(n) allergy is a medical condition that causes a _____ or illness when someone
comes in contact with a particular substance. – reaction
17.Choose the INCORRECT statement: A social history is a record of the medical
conditions of a patient's family that might affect the patient's health
18.A(n) ______ is a patient's record of previous illnesses, procedures, and other medical
details. – past medical history
19.The veterinarian has requested you fill a prescription and explain the dosing to the
owner. The prescription instructions read, "1-tab P.O. QID for 7 days, then BID PRN."
What is the correct interpretation? - Give 1 tablet by mouth every 6 hours for 7 days,
then every 12 hours as needed
20.The patient's social history included the following, except: her previous surgeries
21.Mr. Hallam said that he has been taking over-the-counter medicine for his ______ -
cold
22.Choose the CORRECT statement: data is a collection of information
23."Administer Colace 100 milligrams by mouth three times a day."
Which of the following correctly indicates the order? - Colace 100 mg PO TID
24.Mr. Smith said that he has been taking _____ medicine for his cold. – Over-the-
counter
25.Please give Ms. Williams 50 mg of magnesium ______: morning, noon, and night. –
TID
26."Administer Colace 100 milliliters by mouth four times a day."
Which of the following correctly indicates the order? - Colace 100 ml PO QID
27.A cold is an illness that can cause _____. - coughing, a runny nose, and a sore throat.
28.Jim has been ______all day long. It sounds like he has a serious cold. – coughing
29.Doctors need a full ______ of the patient's condition. – history
30.Who is most likely to be examined by an x ray? – a patient with a broken bone
31.Choose the Correct statement: A biopsy is a medical procedure in which a piece of
tissue is removed and examined to help determine an illness.
32.A(n) ______ will reveal if Mary's baby is a boy or girl. – ultrasound
33.We checked the patient's ______ as soon as she was brought in to the hospital – vital
signs
34.Detailed questions can reveal symptoms that can ______ the diagnosis of a patient –
affect
35.We are waiting for the results of the BUN test to assess the patient's ______ function.
– renal
36.Patients with ______ are waiting for a kidney transplant. – CDK
37.______ is a measure of the pressure with which blood moves through the body – blood
pressure
38.As soon as you see the victim, check first all the ______. – vital signs
39.Choose the correct statement: Electrocardiogram is a measurement of the electrical
activity of the heart over a period of time.
40.A(n) ______ is a medical imaging technique that uses magnetic forces on atoms to
produce an image of the body - magnetic resonance imaging
41.Choose the INCORRECT statement: Palpation is the examination of something by
tapping on an area of the body.
42.Did you check the neck and arms using ______ first before asking for an x-ray? –
palpation
43.An MRI uses ______ of atoms to produce an image of the body. – magnetic forces
44.Which of the following is not an advanced medical imaging technique – xray
45.What is one use for auscultation techniques? - to determine the quality of a patient's
breathing
46.Choose the INCORRECT statement: Auscultation is the examination of something by
touch with or without an instrument such as a stethoscope.
47.Mrs. Sellers is at risk of kidney disease and her ______ function has declined – renal
48.Choose the Correct statement: Albumin is a type of protein found in the body.
49.What is one use for percussion techniques? - to determine the presence or absence of
fluid in body areas
50.The word 'associate' has the closest meaning with _______ - partner
51.Regulatory Affairs ________ documents to regulatory authorities – submits
52.______________ means a description of a working method or process - Standard
operating procedures (SOPs)
53.It's the medical writer's job to _______ clinical and study reports before the
pharmaceutical company submits them to regulatory authorities – research, write, and
edit
54.The Production department _______ the raw materials into drugs, packages them, and
puts in the leaflets for the patients – compounds
55.The Clinical Affairs department _______ or organizes clinical trials on live subjects,
and makes sure that the drugs are safe and effective for the patients – conducts
56.Good morning, and welcome everyone. Great that everyone on the project team could
make it to our ________ meeting – kick-off
57.(1)__________your input (2)__________ , we need the financial data from your
department as soon as possible - (1)As far as; (2)is concerned
58.After receiving a bachelor's degree, pharmacists can continue their studies for several
more years and get a ______, which usually involves research – master’s degree
59.At the end of a meeting, the results of the meeting are often summarized in writing as
action points. This is a(n) ______ - to do list
60.I __________ Johnson & Johnson in their clinical department – used to work at
61.Regulatory Affairs department compiles the drug documentation and submits it to the
drug regulatory authorities so the company can get _________ - authorization to
market the product
62.The Research and Development (R&D) department finds new substances to make new
drug formulations or changes existing ________, for example, from tablets to capsules
- dosage forms
63.A(n) __________ collects drug safety information after approval and reports any
serious adverse events to the health authorities – pharmacovigilance manager
64.A packaging technician ________ - makes sure that suitable, clean containers are
used to get the product from the company to the patient.
65.I ________ the initial conceptual design phase – was involved in
66. A(n) ___________'s job is to make sure that suitable, clean containers are used to get
the product from the company to the patient. - packaging technician
67.You __________ review data in accordance with Good Manufacturing Guidelines -
will need to be able to
68.The main reason I am writing to you is to get your input on a new product.
_________we plan to market a new prescription drug for headaches – as you know
69.The __________ department finds new substances to make new drug formulations or
changes existing dosage forms, for example, from tablets to capsules - Research and
Development (R&D)
70.Choose the word that match the following definition: 'Paperwork necessary to provide
evidence or proof' – SOP
71.A pill is a small, round piece of medicine to be _____- swallowed without chewing