San xuat va phat trien thuoc giao trinh AVCN duoc

PREFACE English for Drug Development and Production Major is intended for senior students whose major is pharmaceutical development and production The book incorporates linguistic skills, pharmacy-related vocabulary and specialized knowledge English for Drug Development and Production Major has been specifically compiled to equip learners with necessary skills and knowledge to understand significant pharmacy-related materials The content of this book covers WHO guidelines for pharmaceutical production and development, USP monograph, physio-chemical properties of some excipients, manufacturing processes, package inserts and journals of pharmaceutical science With an effort of making the textbook an efficient aid in this ESP course, the compilers will be greatly indebted for all constructive feedback or up-to-date information sent to the General English Department of Lac Hong University via generalenglishdept@lhu.edu.vn i TABLE OF CONTENTS Page PREFACE i TABLE OF CONTENTS ii UNIT WHO good manufacturing practices for pharmaceutical products: main principles UNIT WHO good manufacturing practices for pharmaceutical products: Documentation and good practices in production UNIT Pharmaceutical development and production team 25 UNIT USP Monograph on Dosage Forms 34 UNIT Quality Control Tests For Dosage Forms 47 UNIT USP Monograph on Technical Specifications of an Active Substance 61 UNIT Physico- chemical properties of an excipient 71 UNIT Manufacturing process of a coated tablets and sustained release tablets 82 UNIT Manufacturing process of liquid products/cream 89 UNIT 10 Package Inserts 98 UNIT 11 Asian Journal of Pharmaceutical Sciences 103 A GLOSSARY OF DOSAGE FORMS 127 ABBREVIATIONS 134 VOCABULARY 149 ii UNIT WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS MAIN PRINCIPLES SCRUB UP Work with a partner to match each phonetic spelling with its word and try to say it with your partner /ˈstɔːrɪdʒ/ manufacturing /ˈfɑːməsi/ /ˈlæbrətɔːri/ distribution laboratory /ˌdɪstrɪˈbjuːʃn/ /ˌmænjuˈfæktʃərɪŋ/ storage pharmacy Each word above represents an area of good practice Read the definition of GxP and write the full form of each following abbreviation under its suitable picture GxP is a general term for quality guidelines, standards and regulations of Good Practice These guidelines are predominantly used in the pharmaceutical industry and medical device industry GDP - GLP - GPP - GMP - GSP _ _ READING COMPREHENSION Good Manufacturing Practices for Pharmaceutical Products GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification GMP is concerned with both production and QC GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products Under GMP: (a) all manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications; (b) qualification and validation are performed; (c) all necessary resources are provided, including:  sufficient and appropriately qualified and trained personnel,  adequate premises and space,  suitable equipment and services,  appropriate materials, containers and labels,  approved procedures and instructions,  suitable storage and transport,  adequate personnel, laboratories and equipment for in-process controls; (d) instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided; (e) procedures are carried out correctly and personnel are trained to so; (f) records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of products are as expected Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is implemented; (g) records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; (h) the proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practices; (i) a system is available to recall any batch of product from sale or supply; (j) complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence EXERCISE Join these word combinations used in the text associated required a products b risks trained c distribution suitable approved d action e cause in-process root preventive proper 10 marketed f g h i j EXERCISE controls procedures services personnel quality Complete the following sentences with the correct word or expression in bold from the text There should be written describing the action to be taken, including the need to consider a recall, in the case of a complaint concerning a possible product defect If a product defect is discovered or suspected in _, consideration should be given to whether other batches should be checked in order to determine whether they are also affected All competent authorities of all countries to which a given product has been distributed should be promptly informed of any intention to _ the product because it is, or is suspected of being, defective The person responsible for QC should have responsibility, together with other relevant departments, for approving suppliers who can reliably supply starting and packaging materials that meet established _ The function of the approval of the release of a finished batch or a product can be delegated to a designated person with appropriate qualifications and experience who will release the product in accordance with a(n) procedure Any person shown at any time to have an apparent illness or open lesions that may adversely affect the should not be allowed to handle starting materials, packaging materials, in-process materials or medicines until the condition is no longer judged to be a risk To protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering All _ should be trained in the practices of personal hygiene A high level of personal hygiene should be observed by all those concerned with manufacturing processes equipment should be withdrawn from use until the defect has been rectified 10 The _ records should be readily available to the authorized person, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall TRANSLATION Translate the following texts into Vietnamese Storage areas should be designed or adapted to ensure good storage conditions In particular, they should be clean, dry, sufficiently lit and maintained within acceptable temperature limits Where special storage conditions are required (e.g temperature, humidity) these should be provided, controlled, monitored and recorded where appropriate In order to minimize the risk of a serious medical hazard due to crosscontamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products, such as highly sensitizing materials (e.g penicillins) or biological preparations (e.g live microorganisms) The production of certain other highly active products, such as some antibiotics, hormones, cytotoxic substances and certain non-pharmaceutical products, should not be conducted in the same facilities In exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations (including cleaning validation) are made The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of pharmaceutical products Starting materials in the storage area should be appropriately labelled Labels should bear at least the following information: (a) the designated name of the product and the internal code reference where applicable; (b) the batch number given by the supplier and, on receipt, the control or batch number given by the manufacturer, if any, documented so as to ensure traceability; (c) the status of the contents (e.g in quarantine, on test, released, rejected, returned, recalled); (d) where appropriate, an expiry date or a date beyond which retesting is necessary When fully validated computerized storage systems are used, not all of the above information need be in a legible form on the label SELF-STUDY EXERCISE Read the text and complete it using words from below investigated one-off minimize defective validated cross-contamination segregated area corrective action solvents detect routinely first-expire eliminated qualified quarantined WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles A- In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled Any aspect of operation, including significant changes to the premises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and (1) Qualification and validation should not be considered as _(2) exercises An on-going programme should follow their first implementation and should be based on an annual review Particular attention should be paid to the validation of analytical test methods, automated systems and cleaning procedures B- A high level of sanitation and hygiene should be practised in every aspect of the manufacture of medicines The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product Potential sources of contamination should be (3) through an integrated comprehensive programme of sanitation and hygiene C- All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the (4) should be taken Any complaint concerning a product defect should be recorded with all the original details and thoroughly (5) The person responsible for QC should normally be involved in the review of such investigations D- There should be a system to recall from the market, promptly and effectively, products known or suspected to be (6) An instruction should be included in the written procedures to store recalled products in a secure (7) while their fate is decided The distribution records should be readily available to the authorized person, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall E- The purpose of self-inspection is to evaluate the manufacturer‘s compliance with GMP in all aspects of production and QC The self-inspection programme should be designed to (8) any shortcomings in the implementation of GMP and to recommend the necessary corrective actions Self-inspections should be performed (9), and may be, in addition, performed on special occasions, e.g in the case of product recalls or repeated rejections, or when an inspection by the health authorities is announced The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively All recommendations for corrective action should be implemented The procedure for selfinspection should be documented, and there should be an effective follow-up programme F- The establishment and maintenance of a satisfactory system of QA and the correct manufacture and control of pharmaceutical products and active ingredients rely upon people For this reason there must be sufficient (10) personnel to carry out all the tasks for which the manufacturer is responsible Individual responsibilities should be clearly defined and understood by the persons concerned and recorded as written descriptions G- Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out The layout and design of equipment must aim to (11) the risk of errors and permit effective cleaning and maintenance in order to avoid (12), build-up of dust or dirt, and, in general, any adverse effect on the quality of products H- The main objective of a pharmaceutical plant is to produce finished products for patients‘ use from a combination of materials (starting and packaging) Materials including starting materials, packaging materials, gases, (13), process aids, reagents and labelling materials No materials used for operations such as cleaning, lubrication of equipment and pest control should come into direct contact with the product Where possible, such materials should be of a suitable grade (e.g food grade) to minimize health risks All incoming materials and finished products should be (14) immediately after receipt or processing, until they are released for use or distribution All materials and products should be stored under the appropriate conditions established by the manufacturer, and in an orderly fashion, to permit batch segregation and stock rotation by a (15) first-out rule Water used in the manufacture of pharmaceutical products should be suitable for its intended use EXERCISE Choose the best headings (1-8) to match the sections of the text above (A-H) Materials Premises and equipment Personnel Self-inspection, quality audits and suppliers‘ audits and approval Sanitation and hygiene Product recalls Complaints Qualification and validation EXERCISE Answer these questions about the text What does the scope of sanitation and hygiene cover? How often should self-inspections be performed? What is the purpose of selfinspection? What should the distribution records contain? Why? VOCABULARY  adj adjective tính từ adv adverb trạng từ n noun danh từ v verb động từ UNIT - antibiotic(n): kháng sinh - approved procedure: trình phê duyệt - corrective action: hoạt động hiệu chỉnh - cytotoxic substances: chất có khả cản phân bào - defective product: sản phẩm bị lỗi - eliminate(v): loại bỏ - first-expire first-out rule: quy tắc hết hạn trước xuất kho trước - in-process control: kiểm sốt trình hoạt động - investigate(v): điều tra - marketed product: sản phẩm bán thị trường - minimize(n): giảm đến mức tối thiểu - qualified personnel: nhân viên có trình độ chun mơn - quality audit: giám sát/kiểm tra chất lượng - quarantine(n): tình trạng biệt trữ - routinely(adv.): thường xuyên/ đặn - segregated area: khu vực cách ly - self-inspection(n): tự tra - solvent(n): dung môi - specification(n): tiêu chuẩn kỹ thuật - spot-check(n): kiểm tra đột xuất - stock rotation: quay vòng tồn kho - traceability(n): truy tìm nguồn gốc 135 UNIT - audit trail(n): - back-up transfer: biên kiểm tra, lịch sử hoạt động lưu dự trữ - batch(n): - biological(adj.): lô (hàng sản xuất) (thuốc điều trị) có nguồn gốc sinh học - bulk product(n): - calibrate(n): - compatible with: bán thành phẩm hiệu chỉnh, kiểm chuẩn tương thích với - compendia(n): - conform to: - cross-contamination(n): phụ lục/bổ sung phù hợp với (tiêu chuẩn) lây nhiễm/ nhiễm khuẩn chéo - documentation(n): - electronic disc: tài liệu / hồ sơ đĩa điện tử - finished product: - hazardous contaminant: - intrude(v): - live vaccine: - magnetic tape(n): - master formulae: - microfilm(n): thành phẩm tạp chất nguy hiểm xâm nhập vắc-xin sống băng từ công thức nhà sản xuất vi phim - mix-up(n): - periodically(adv.): - pest control(n): - pharmacopoeial monograph: - quality assurance: - requisite quality: - sensitizing material: - shelf-life(n): - stability(n): - unambiguous content: nhầm lẫn định kỳ kiểm sốt trùng chuyên luận dược điển đảm bảo chất lượng chất lượng theo yêu cầu chất làm nhạy thời hạn sử dụng dược phẩm tính ổn định nội dung rõ ràng - undergo(v): - vapour(n): trải qua dạng 136 UNIT - approval (n): phê duyệt, đồng ý - clinical research: nghiên cứu lâm sàng - delegate (v): uỷ quyền, giao phó - designated person: người định - deviation (n): lệch hướng sai lệch - physiology (n): sinh lý học - quality unit: phận quản lý chất lượng - regulatory authority: quan ban hành quy chế - toxicology (n): độc chất học - well-defined (adj): rành mạch, rõ ràng UNIT - aerosol (n): thuốc phun, thuốc xịt - aromatic water (n): nước thơm - aural (auricular) (adj.): qua lỗ tai - bead (n): hạt - binder (n): tá dược dính - block (n): thuốc dạng khối - bolus (n): viên thuốc to - buccal tablet (n): viên nén ngậm má - capsule (n): viên nhộng, viên nang cứng - chewable tablet (n): viên nhai - coated (adj.): có bọc (e.g a sugar-coated tablet: viên bọc đường) - collodion (n): hệ keo - collodial dispersion: phân tán keo - concentrate (n): chất đặc - conventional-release: (thuốc) phóng thích thường/qui ước 137 - cream (n): (thuốc dạng) kem - delayed-release: phóng thích trì hỗn - dental (adj.): (thuộc) - dermal (adj.): (thuộc) da - diluent (n): chất pha loãng, tá dược độn - disintegrating agent (n): chất làm tan, tá dược rã - dosage form: dạng phân liều - dry powder inhaler: ống hít bột khơ - effervescent tablet (n): viên sủi - elixir (n): cồn - emollient (n): chất làm mềm da - emulsion (n): nhủ tương (một dạng phân liều) - enteric-coated tablet: viên bao tan ruột - excipient (n): tá dược - extended-release: (thuốc) phóng thích kéo dài - filler (n): chất làm đầy/ tá dược độn - film (n): màng bao phim - foam (n): bọt (một dạng phân liều) - gas (n): thể khí - gastro-resistant: kháng dịch dày - gel (n): thuốc dạng gel, chất keo - glidant (n): tá dược trơn - granules (n): cốm thuốc (một dạng phân liều) - granulation (n): tạo hạt, xát cốm - gum (n): chất gôm, chất keo, kẹo cao su (một dạng phân liều) - hard-shell capsule (n): viên nhộng cứng - hypodermic tablet (n): viên nén để sử dụng da - immediate-release: (thuốc) phóng thích - implant (n): viên cấy (dạng phân liều) 138 - inhalation (n): hít vào, xơng - injection (n): tiêm chích - insert (n): thuốc đặt, viên nhét (một dạng phân liều) - intraocular (adj.): qua mắt - irrigation (n): dung dịch rửa (vết thương) - jelly (n): chất đông, thạch - liquid (n): dạng dịch lỏng (một dạng phân liều) - lotion (n): thuốc xức da (một dạng phân liều) - lozenge (n): viên ngậm - lubricant (n): tá dược trơn bóng - modified-release: (thuốc) phóng thích biến đổi - molded tablet (n): viên thuốc đóng khn - mouthwash (n): thuốc súc miệng - nasal (adj.): (thuộc về) mũi - ocular (adj.): (thuộc về) mắt - ointment (n): thuốc mỡ - ophthalmic (adj.): thuộc mắt (thuốc) - orally disintegrating: rã miệng - oro-pharyngeal (adj): (thuộc) miệng - hầu - otic (adj.): (thuộc) tai - paste (n): bột nhão (một dang phân liều) - patch (n): miếng thuốc dán (một dạng phân liều) - pellet (n): hạt thuốc nhỏ, hạt cải (một dạng phân liều), vi hạt - periodontal (adj.): cận răng, quanh - pill (n): viên thuốc (hình cầu) (một dạng phân liều) - plaster (n): thuốc cao (một dạng phân liều) - powder (n): thuốc bột (một dạng phân liều) - powder, inhalation (n): bột hít (một dạng phân liều) 139 - preparation (n): điều chế - prolonged-release: extended-release (phóng thích kéo dài) - rectal (adj.): trực tràng - semisolid (adj.): nửa rắn - shampoo (n): dầu gội (một dạng phân liều) - soap (n): xà phòng (một dạng phân liều) - soft gel capsule (n): viên nang mềm (một dạng phân liều) - solution (n): thuốc nước (một dạng phân liều) - spirit (n): rượu mạnh - spray (n): thuốc xịt - stent, drug-eluting (n): ống stent thuốc/dẫn thuốc/phủ thuốc - strip (n): băng keo y tế (ít sử dụng tape); vỉ thuốc - sublingual (adj.): lưỡi - suppository (n): thuốc đạn (nhét vào hậu môn, âm đạo,…) - suspension (n): hỗn dịch/ dịch treo (chế phẩm đục, lơ lửng) - syrup (n): sirô - tablet (n): viên nén - tablet triturates: thuốc tán thành bột - tape, medicated (n): băng keo y tế - tincture (n): cồn thuốc - topical (adj.): (thuốc dùng) chỗ - transdermal system (n): hệ điều trị qua da (miếng dán) - troche (n): viên ngậm dẹp (ít sử dụng lozenge) - urethral (adj.): qua niệu đạo - vaginal (adj.): qua âm đạo - vehicle (n): chất dẫn - veterinary (adj.): thuộc thú y 140 UNIT - acceptance criteria: tiêu chuẩn chấp nhận - apparatus(n): dụng cụ, thiết bị - assay(n): thí nghiệm, thử nghiệm - buffer(n): dung dịch đệm - concentration(n): nồng độ - chromatographic system: hệ thống sắc ký - dissolution(n): tan rã, hòa tan - dry ice(n): nước đá khơ - flask(n): bình tam giác/ bình nón (thí nghiệm) - imprurity(n): tạp chất - medium(n): mơi trường - mobile phase: pha động - particle size: kích thước cỡ hạt - propellant(n): khí đẩy - relative standard deviation: độ lệch chuẩn tương đối - resolution(n): thông số dùng đánh giá mức độ tách phân tử s inh học mẫu - retention time: thời gian lưu/thời gian phân tử sinh học khỏi cột sắc ký tính từ lúc nạp mẫu - sample solution: dung dịch thử - standard solution: dung dịch chuẩn - stock solution: dung dịch gốc - stopper(n): nút (bình thí nghiệm/ lọ bột pha tiêm) - tailing factor: hệ số không đối xứng T/ hệ số kéo đuôi - tolerance(n): dung sai - ultraviolet absorption: hấp thụ tia cực tím - uniformity(n): tính đồng 141 UNIT - active substance: hoạt chất - anhydrous(adj.): khan - crystallinity(n): tính kết tinh - endotoxin(n): nội độc tố - infrared(adj.): tia hồng ngoại - light-resistant(n): chất chống ánh sáng - solvent(n): dung môi - sterility(n): vô trùng - infrared absorption: hấp thụ quang phổ hồng ngoại (IR) - ultraviolet absorption: hấp thụ quang phổ cực tím (UV) UNIT - analytical reagent (n) chất phản ứng phân tích - applications (n) ứng dụng - bacteriostatic (a) kìm hãm vi khuẩn - bioavailability (n) sinh khả dụng - category (n) danh mục - composition (n) thành phần - compound (n) hợp chất - concentration (n) nồng độ - diluent (n) chất làm loãng - formulation (n) bào chế/ thiết lập công thức - formulator (n) người lập công thức - functional (a) chức - fusion (n) dung hợp, chảy lỏng - inert (a) trơ - inhalation (n) hít, xơng - irrigation (n) rửa vết thương - microbial (a) thuộc vi trùng, vi khuẩn 142 - novel form (n) dạng - ophthalmic (a) thuộc mắt, liên quan tới mắt - pharmacologically (adv.) dược lý - potable (a) uống - property (n) đặc tính - solubility (n) độ tan - solvent (n) dung môi - specific gravity (n) trọng lượng riêng - stability (n) độ ổn định - sterile (a) vô trùng - storage (n) bảo quản - surface tension (n) sức căng bề mặt - vehicle (n) chất dẫn thuốc - viscosity (n) độ nhớt UNIT - dispersion (n): chất làm phân tán, hệ phân tán - disperse (v): phân tán - uniformly (adv.): cách đồng - syrup base: chất si-rô - homogenize (v): trình đồng hóa - flocculation (n): kết cụm - handle (v): xử lý - mucilage (n): chất nhày - handling loss: hao hụt trình xử lý - uniform suspension (n): hỗn dịch đồng - mix (v): trộn - dissolve (v): hòa tan - cool down: hạ nhiệt độ - approximately (adv.): xấp xỉ, khoảng chừng - filter (v): lọc 143 - stainless steel: thép không gỉ - tank (n): thùng - homogeneous (adj.): đồng - rinse (v): rửa - uniformity (n): độ đồng - bar (n): đơn vị áp suất - vacuum (n): hút chân khơng - volume (n): dung tích, thể tích - transfer (v): chuyển - sieve (n): rây - storage tank: thùng chứa - manual mode: chế độ điều chỉnh tay - load (v): thêm vào, chất thêm - fat-melting vessel: bình để làm chảy chất béo - slurry (n): chất sền sệt/ bột nhão - aqueous phase: pha nước - fatty phase: pha dầu - release (v): phóng thích - recirculation (n): tái ln chuyển - firm (v): trở nên rắn - clarity (n): độ - determine (v): xác định - ethanol concentration: nồng dộ cồn - preservative (adj): bảo quản - efficiency (n): hiệu - butyhyldroxytoluene (n): (tên chất chống ô-xi hóa) - antioxidant (n): 144 chất chống ơxi hóa UNIT - inactive ingredient: tá dược - microcrystalline cellulose: vi tinh thể cen-lu-lô - starch (n): tinh bột - vessel (n): bình, lọ - formation (n): thành lập - lump (n): cục, tảng - stir (v): khuấy - form (v): tạo thành - exceed (v): vượt - gelatin (n): tá dược giê-la-tin - mill (v): nghiền - magnesium carbonate heavy: magiê cacbonat tỉ trọng nặng - mixed powder: bột trộn - inspect (v): tra - granulation (n): kết thành hột nhỏ - proceed to sth: tiến đến - granulator (n): máy tạo hạt - granule (n): hột nhỏ - paper-lined tray: khay lót giấy - fluid- bed dryer: máy sấy tầng sôi - turn over: lật, giở - polyethylene - lined drum: trống PE - lubrication (n): bôi trơn, tra dầu mỡ - blender (n): máy trộn - compression (n): nén viên, dập viên - punch (n): chày - disintegration (n): rã 145 - coating (n): bọc, bao - gloss (n): nước bóng - active drug: hoạt chất - passage: chuyển qua - mesh screen: mắt lưới - caplet (n): viên nén hình viên nang - target weight: khối lượng viên cần đạt - target hardness: độ cứng cần đạt - target thickness: độ dày cần đạt - bath (n): bình chứa dung dịch - pan (n): thùng, bình - planned theoretical weight gain: đạt khối lượng theo lí thuyết ban đầu - fluidize (v): phun - adjust (v): điều chỉnh - cure (v): chữa bệnh 146 UNIT 10 - prospectus (n) tờ thông tin thuốc - loosen (v) làm lỏng - phlegm (n) đờm dãi - mucus (n) dịch nhầy - bronchial secretion (n) dịch tiết phế quản - rid (v) loại bỏ, giải thoát - bronchial passageway (n) ống phế quản - bothersome (adj.) gây khó chịu - relieve (v) làm nhẹ, bớt, giảm - irritation (n) kích thích, làm tấy lên, kích ứng - irritant (n) chất gây kích ứng - inhale (v) hít vào - impulse (n) thúc - inhibitor (n) chất gây ức chế - psychiatric (adj.) bệnh tâm thần - persistent (adj.) dai dẳng - chronic (adj.) mạn tính - asthma (n) bệnh hen, suyễn - bronchitis (n) bệnh viêm phế quản - emphysema (n) bệnh khí thũng - breast-feeding (n) cho bú - overdose (n) liều - tamper evident (n) chứng giả mạo 147 UNIT 11 - matrix-type (n) kiểu ma trận - transdermal therapeutic system (n) hệ thống trị liệu qua da - ratio (n) tỷ lệ - hydrophilic (adj.) thân nước - hydrophobic (adj.) kị nước - combination (n) phối hợp/kết hợp - solvent evaporation technique (n) kỹ thuật bốc dung mơi - physicochemical compatibility (n) khả tương thích hóa lý - infrared spectroscopy (n) quang phổ hồng ngoại - respectively (adv.) riêng cái, tương ứng - penetration enhancer (n) chất làm tăng tính thấm - plasticizer (n) chất làm dẻo - vitro release (n) phóng thích vi-trơ - moisture absorption (n) hấp thụ nước, hút ẩm - mechanical properties (n) tính chất học - diffusion (n) khuếch tán - diffusion mediated (n) khuếch tán qua trung gian - emerge (v) nảy sinh, xuất - efficacy (n) tính hiệu - allergic condition (n) tình trạng dị ứng 148 REFERENCES [1] Michaela Bücheler, Kathy Jaehnig, Gloria Matzig, Tanya Weindler (2010) English for the Pharmaceutical Industry Oxford University Press [2] Grice T (2007) Oxford English for Careers: Nursing1 Oxford University Press [3] McCater, S (2009) Oxford English for Careers: Medicine Oxford University Press [4] Rowe, R C., Sheskey, P J., Cook, W G., Fenton, M E (eds.) (2012) Handbook of Pharmaceutical Excipients (7th ed.) Pharmaceutical Press [5] Thomas, G (2000) Medicinal chemistry, John Wiley & Son, Ltd [6] United States Pharmacopeia (USP36) (2013) Rockville, MD: United States Pharmacopeia Convention [7] http://www.drugs.com › Professionals › FDA PI [8] http://www.pharmscidirect.com / Int J Pharm Biomed Res 2010, 1(2), 42-47 [9] http://www.who.int/en/ 149 ... audits and approval Sanitation and hygiene Product recalls Complaints Qualification and validation EXERCISE Answer these questions about the text What does the scope of sanitation... conclusions reached should be available for: (a) equipment assembly and validation; (b) (c) (d) (e) (f) (g) (h) analytical apparatus and calibration; maintenance, cleaning and sanitization; personnel... process validation and calibration of analytical apparatus; (e) training, including the application and principles of QA; (f) approval and monitoring of suppliers of materials; (g) approval and