Платформа аппарата. GMP-T. [Редактировать]

Новостная лента[Найти информацию в новостях] [Найти информацию в документах]

#Новостная лента.
12014-12-07. Спутниковый оператор Eutelsat объявил о покупке геостационарного аппарата у SSTL. Спутниковый дизайн аппарата был назван аппаратом Quantum и включает аналоговый бортовой процессор и фазированную антенну от Airbus, а также платформу GPM-T от SSTL.Тэги: Eutelsat Communications S.A.GMP-TSSTL

Технические характеристики

#ХарактеристикаЗначение
1Масса (аппарата на платформе), кг3500
2Масса (полезная нагрузка), кг450
3Мощность, Вт5000

Экономические характеристики

#ХарактеристикаДата измеренияЗначение
1Стоимость (разработки), млн. долл.95

Найдено 1000 документов по запросу «GMP-T». [Перейти к поиску]


Дата загрузки: 2017-11-08
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0.5/5
... mengaplikasikan HACCP adalah dengan diterapkannya GMP (Good Manufacturing Practices) dan SSOP... sistem HACCP dengan mengkaji pelaksanaan GMP, SSOP, dan penyusunan HACCP Plan... MUTU ...................................................................................................... 11 3.2 GOOD MANUFACTURING PRACTICES (GMP) .................................................... 13 3.3 SANITATION STANDARD OPERATING PROCEDURE... ................................................................ 25 4.2 METODE PENELITIAN ......................................................................................... 25 PROJECT I. GMP,SSOP & HACCP ......................................................................... 25 PROJECT II... V. HASIL DAN PEMBAHASAN ......................................................................................... 34 PROJECT I. GMP, SSOP & HACCP 5.1 OBSERVASI LAPANG DAN... HACCP .................................................................................................................... 34 5.1.1 Good Manufacturing Practices (GMP .................................................... 34 5.1.2 Sanitation Standard Operating Procedure... 7. Diagram Sebab Akibat Permasalahan Penerapan GMP dan SSOP di Pabrik Lion... mengaplikasikan HACCP adalah dengan diterapkannya GMP (Good Manufacturing Practices) dan SSOP... sistem HACCP dengan mengkaji pelaksanaan GMP, SSOP, dan penyusunan HACCP Plan... (Manik 2004) 3.2 GOOD MANUFACTURING PRACTICES (GMP) Good Manufacturing Practices merupakan prasyarat... dalam sistem manajemen keamanan maupun GMP (Good Manufacturing Practices) dengan cara... selama satu jam. 4.2 METODE PENELITIAN 4.2.1 GMP,SSOP & HACCP Pada kegiatan magang ini dilakukan pengkajian GMP dan SSOP serta penyusunan HACCP... Pengkajian Pre-requisite Program HACCP (GMP & SSOP) Mendefinisikan Ruang Lingkup Penerapan... Pengkajian Pre-requisite Program HACCP (GMP & SSOP) Ruang lingkup observasi pre... HACCP di lapangan terfokus penerapan GMP dan SSOP di Pabrik Lion... kegiatan identifikasi permasalahan dalam penerapan GMP dan SSOP di pabrik yang... pada pabrik baru ini. PROJECT I. GMP, SSOP & HACCP 5.1 OBSERVASI LAPANG PROGRAM... PENGKAJIAN PRE-REQUISITE GMP (Good Manufacturing Practices) GMP merupakan salah satu prasyarat... pengamatan di lapangan, sebagian program GMP belum maksimal dilakukan di Pabrik... Unilever Indonesia Tbk. Hasil pengamatan GMP di Pabrik Lion berdasarkan standar GMP PT Unilever Indonesia Tbk adalah ... mayoritas berbahan dasar tepung. Standar GMP untuk penyimpanan bahan baku tepung... pabrik ini sudah memenuhi standar GMP. Fasilitas cuci tangan juga harus... karyawan masih ditemukan kekurangan pelaksanaan GMP pada saat berproduksi, antara lain... dapat bersumber dari pekerja. Standar GMP yang berlaku untuk para pekerja... baku merupakan aplikasi dari kegiatan GMP dan merupakan salah satu bagian.... Hal di atas sesuai dengan GMP tentang karyawan. 8. Pencegahan hama pabrik.... 42 Dari keseluruhan hasil pengamatan GMP dan SSOP di pabrik ini... prinsip-prinsip GMP dan SSOP. Beberapa penyebab permasalahan penerapan GMP dan SSOP... Fasilitas Produksi Maintenance Managemen Penerapan GMP dan SSOP di Pabrik Lion... 7. Diagram Sebab Akibat Permasalahan Penerapan GMP dan SSOP di Pabrik Lion... perusahaan dengan mulai diterapkannya audit GMP secara berkala. 43 Beberapa usulan perbaikan untuk GMP & SSOP di pabrik ini diantaranya... pabrik sebagai langkah perbaikan penerapan GMP dan SSOP di pabrik baru... DAN SARAN PROJECT I. GMP, SSOP & HACCP 6.1 KESIMPULAN GMP dan SSOP merupakan salah... lapangan, secara umum keseluruhan penerapan GMP dan SSOP di pabrik ini...



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0.22/5
...şkanlığı............................................................................................................92 5.5.1 İlaç Üretim Yeri (GMP) Denetleme Birimi.........................................................................................94 5.5.4 İyi Farmakovijilans...ı (GDP) Denetim Birimi...........................................................................96 5.5.5 Kozmetik GMP Denetleme ve PGD Birimi.........................................................................................97... Dağılımı..........................................................................................40 Tablo 11: Kozmetik GMP/PGD Faaliyetleri.........................................................................................................................97 Tablo 12... FDA GCP GÇG GDP GDK GLP GMP GPvP GZFT HÇG ISO İEGM İTS... ürün üretim yerlerinin iyi üretim uygulamaları (GMP) koşullarına uygun üretim... ürünlere ait “Farmasötik Ürün Sertifikası”, “GMP ve Serbest Satış Sertifikası” nın İngilizce...ğrultusunda yurt içi üretim yerleri için GMP Certificate (İngilizce), İyi İmalat Uygulamalar... of Pharmaceutical Product-CPP) ve GMP and Free Sales(İngilizce) ve GMP ve Serbest Satış Sertifikası (Türkçe) dü... yazı ile bildirilmesi, ✓ Üretim yerlerinin GMP’ye uygunluğuna ilişkin... toplantıda ruhsatlandırma ve GMP belgelendirmesine ilişkin değerlendirmeler... yılı Mart ayında uygulamaya konulan GMP denetimlerinin AB ve ABD’de... yılı Mart ayında uygulamaya konulan GMP denetimlerinin AB ve ABD’de... görüş verilmiştir. ✓ Avrupa Birliği ile GMP belgelerinin karşılıklı tanınmas.... Bu birimler; 1. İlaç Üretim Yeri (GMP) Denetleme Birimi 2. İyi Klinik/Laboratuvar... Farmakovijilans Uygulamaları Denetim Birimi 5. Kozmetik GMP Denetleme ve PGD Birimi 6. Tıbbi... belirtilmiştir; 5.5.1 İlaç Üretim Yeri (GMP) Denetleme Birimi ✓ Yurt içi denetimleri için.../izinli ürünlerin ise rutin olarak, GMP denetimlerinin gerçekleştirilmesi, bu.../dolum/depolama ve dağıtım tesisi, GMP mevzuatı gereğince denetlenmiştir... İDARE FAALİYET RAPORU 5.5.5 Kozmetik GMP Denetleme ve PGD Birimi ✓ Etkin bir PGD sistemi ve GMP denetimleri ile topluma kaliteli ve... görüldüğü gibidir; Tablo 11: Kozmetik GMP/PGD Faaliyetleri İŞLEMİN TÜRÜ Denetlenen Ürün SAYISI...), kozmetik ürünlerin İyi imalat uygulamaları (GMP) ile Piyasa Gözetimi ve Denetimi... ve mümessil ecza depolarında GMP/GDP, GCP, GPvP denetimi yap...ıştır. ✓ Yurt dışında üretilen ürünün üretim yerinin GMP denetimi için; başvuru kılavuzu... yılı Mart ayında uygulamaya konulan GMP denetimlerinin AB ve ABD’de... sunulmuştur. ✓ Avrupa Birliği ile GMP belgelerinin karşılıklı tanınmas...



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0/5
... natriuretic factor and plasma cyclic GMP levels, lowered arterial pressure for... atrial natriuretic factor or cyclic GMP, and suppressed both plasma aldosterone... were given together, plasma cyclic GMP but not atrial natriuretic factor...,15 cyclic guanosine 3',5'-monophosphate (cyclic GMP),15 aldosterone,16 angiotensin II... ranged from 55% for cyclic GMP to 7.2% for ANF. Half-life... SCH+ANF ANF (pmol/1) Cyclic GMP (nmol/1) Aldosterone (pmol/1) Ang II...; ANF, atrial natriuretic factor, cyclic GMP, cyclic guanisine 3',5' monophosphate; Ang II... plasma ANF (/7=O.O3) and cyclic GMP (77=0.016), which peaked at... 5 nmol/1 for ANF and cyclic GMP, respectively. Values returned toward basal... the return of plasma cyclic GMP and ANF to basal levels... alone, respectively; p=0.002). Plasma cyclic GMP levels also increased promptly in..., the elevation in plasma cyclic GMP was almost double that observed... when plasma ANF and cyclic GMP levels had returned to baseline... plasma ANF and plasma cyclic GMP, reduced blood pressure, and reduced... both plasma ANF and cyclic GMP, both of which were sustained... in plasma ANF and cyclic GMP parallel the time course of... of both ANF and cyclic GMP were lower than those induced..., the increment in plasma cyclic GMP associated with SCH 39370 plus... any effect on plasma cyclic GMP or ANF) is consistent with... on plasma ANF and cyclic GMP are similar both in sheep... in plasma ANF and cyclic GMP and promote biological effects consistent... • aldosterone blood pressure * glucocorticoids • cyclic GMP



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0.15/5
... между странами и фармацевтическими инспекторатами в области GMP. В ходе встречи был подписан Меморандум... оценки производств на соответствие требованиям GMP и отметила, что подписание МемоВыступление председателя... на работу в соответствии с европейскими стандартами GMP, модернизацию и повышение ее экспортного потенциала.../CVMP), документы Европейской комиссии (стандарт GMP). Сертификация проводится в нескольких модификациях: общая... препаратам, препаратам растительного происхождения, инспекторат GMP/GDP Комитета по лекарственным средствам... и полупродукты для поставок в ЕС, требованиям GMP обязательно. АФС гепаринов (включая низкомолекулярные..., подтверждающим соответствие производственной площадки требованиям GMP. Сведения о производственной площадке включаются в сертификат... органов. Инспекция проходит в соответствии с требованиями GMP Международной конференции по гармонизации. Проводится..., фармацевтические субстанции, фармацевтическая промышленность, правила GMP, качество лекарственных средств Key words... of China, medicines, pharmaceutical substances, GMP rules, quality of medicines ФАРМАЦЕВТИЧЕСКИЙ... ции, выдачи лицензии, сертификации по GMP и GSP, маркировки, упаковки, рекламы, ценообразования... лекарственных средств должны иметь сертификат GMP. Все оптовые и розничные фармацевтические предприятия... (обращение в местный AIC; получение сертификата GMP, обращение в управления по фармации различных... АФС и лекарственных препаратов соответствуют стандартам GMP. Кроме того, в китайском секторе производства... отечественной фармацевтической промышленности и внедрению стандартов GMP. Уже традиционным на «Фарммедобращении» стало...



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0.04/5
... небольшой производственный отдел с приближением к требованиям GMP, оснащенный полифункциональным технологическим полупромышленным оборудованием..., законодательства, отраслевых стандартов (ОСТ), стандарта GMP, основ GLP, GCP. Особенно востребованы... по организации производства согласно стандарту GMP и специалисты по регистрации лекарственных средств... нормативно-правовыми актами, например, проведение GMP инспекций, концепция уполномоченного лица на..., требование гарантий соблюдения 224 стандартов GMP от компетентных органов третьих стран... перехода отечественных предприятий на стандарты GMP необходимо дальнейшее законодательное и финансовое стимулирование... и строительства новых площадок; формирования штата GMP инспекторов международного класса; создание системы непрерывного обучения в сфере GMP; организация программ по обмену опытом... качества в сфере обращения ЛС, данные о GMP проверках производителей. ДОЗОЗАВИСИМОЕ ВЛИЯНИЕ 10...



Дата загрузки: 2017-11-08
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0.11/5
...-ЗА КОТОРОГО ИХ СЛЕДУЕТ СОГЛАСНО GMP НАРАБАТЫВАТЬ В ОТДЕЛЬНЫХ ПОМЕЩЕНИЯХ А) аллергенность Б) общая... И НА ОТДЕЛЬНОМ ОБОРУДОВАНИИ ПРЕДУСМАТРИВАЮТ ПРАВИЛА GMP А) вакцин БЦЖ Б) биологических препаратов на... контролю качества лекарственных средств В) ГОСТ Г) GMP 2040. ПРИДАВАЕМОЕ ЛЕКАРСТВЕННОМУ СРЕДСТВУ ИЛИ... схема 348 2389. ЧАСТЬ СИСТЕМЫ GMP, КОТОРАЯ ГАРАНТИРУЕТ, ЧТО ИСХОДНОЕ СЫРЬЕ... В А) государственной фармакопее Б) промышленном регламенте В) правилах GMP Г) отраслевом стандарте КАЧЕСТВО 2392. СИСТЕМА... ПРОИЗВОДСТВА ЛЕКАРСТВЕННЫХ СРЕДСТВ ИЗЛОЖЕНА В А) правилах GMP Б) приказах Минздрава РФ В) промышленном регламенте... регламенте Б) приказах Минздрава РФ В) правилах GMP Г) правилах GPP КОНКРЕТНОГО ЛЕКАРСТВЕННОГО 2394... предприятия Б) приказах Минздрава РФ В) правилах GMP Г) правилах GPP ЛЕКАРСТВЕННОГО 349 2395... GLP В) приказах МЗ РФ Г) правилах GMP 2399. РАСЧЕТ РЕГЛАМЕНТНОГО РАСХОДНОГО КОЭФФИЦИЕНТА...



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0.08/5
.... Our implementation is based on GMP, a free library for arbitrary precision... around the mpq t objects of GMP’s C interface, not only for convenience... under http://soplex.zib.de/. GMP. The GNU Multiple Precision Arithmetic... improves memory allocation procedures for GMP by a slab pool management similar... with GCC 4.8.2 and linked to GMP 5.1.3 and EGlib 2.6.20. Instances. We... wrapper class around the rational GMP data type described in Section... linked to the external libraries GMP 5.1.3, EGlib 2.6.20, and zlib 1.2.8 for... linked to the external libraries GMP 5.1.3 and EGlib 2.6.20. 4.2.2 Computational Results...



Дата загрузки: 2017-06-14
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0.14/5
....9.2.3 GMP 2013 10.2.1 Liquid egg products GMP 2013 10.2.2 Frozen egg products GMP... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP..., crustaceans, and echinoderms GMP 2013 12.1.2 Salt Substitutes GMP 2013 13.1.2 Follow....1.2.1 Fruit juice GMP 2005 14.1.2.2 Vegetable juice GMP 2013 GMP 2013 2013 200... juice GMP 2013 14.1.3.1 Fruit nectar GMP 2005 14.1.3.2 Vegetable nectar GMP 2013 14.1.3.3 Concentrates for fruit nectar GMP... juice GMP 14.1.2.3 Concentrates for fruit juice GMP 14.1.3.1 Fruit nectar GMP 14.1.3.3 Concentrates for fruit nectar GMP Notes... GMP 2013 01.2.2 Renneted milk (plain) GMP 2013 01.4.1 Pasteurized cream (plain) GMP..., and echinoderms GMP 12.1.1 Salt GMP 2006 12.1.2 Salt Substitutes GMP 2013 13... products, excluding whey cheeses GMP 2006 02.2.1 Butter GMP 2008 13.1.1 Infant... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP....2.2 Frozen egg products GMP 2013 12.1.2 Salt Substitutes GMP 2013 13.1.2 Follow....2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01.4.2 Sterilized and... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... mollusks, crustaceans, and echinoderms GMP 12.1.2 Salt Substitutes GMP 14.1.5 Coffee, coffee....2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01.4.2 Sterilized and... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP....2.2 Frozen egg products GMP 2013 12.1.2 Salt Substitutes GMP 2013 13.1.2 Follow...-treated after fermentation GMP 01.2.2 Renneted milk (plain) GMP Notes 234 Year... Adopted 2006 36 2013 GMP 16 2013 GMP 16 2013 CODEX STAN..., sugar toppings) GMP 12.1.1 Salt GMP 2006 12.1.2 Salt Substitutes GMP 2013 14..., crustaceans, and echinoderms GMP 12.1.2 Salt Substitutes GMP 13.2 Complementary foods for... GMP 115 2005 14.1.2.2 Vegetable juice GMP 14.1.2.3 Concentrates for fruit juice GMP 14.1.2.4 Concentrates for vegetable juice GMP 2013 14.1.3.1 Fruit nectar GMP 2005 14.1.3.2 Vegetable nectar GMP 2013 14.1.3.3 Concentrates for fruit nectar GMP... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP Notes... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP....2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01.4.2 Sterilized and... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... juice GMP 14.1.2.3 Concentrates for fruit juice GMP 14.1.3.1 Fruit nectar GMP 14.1.3.3 Concentrates for fruit nectar GMP Notes... GMP 2013 01.2.2 Renneted milk (plain) GMP 2013 01.4.1 Pasteurized cream (plain) GMP... children Notes GMP 2000 mg/kg GMP 2000 mg/kg GMP Year Adopted... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... after fermentation GMP 01.2.2 Renneted milk (plain) GMP 12.1.1 Salt GMP Notes 234... juice GMP 14.1.2.3 Concentrates for fruit juice GMP 14.1.3.1 Fruit nectar GMP 14.1.3.3 Concentrates for fruit nectar GMP Year... products, excluding whey cheeses GMP 2006 02.2.1 Butter GMP 2008 04.2.2.7 Fermented... fermentation GMP 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP..., crustaceans, and echinoderms GMP 10.2.1 Liquid egg products GMP 2013 10.2.2 Frozen... mollusks, crustaceans, and echinoderms GMP 12.1.2 Salt Substitutes GMP 14.1.5 Coffee, coffee... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP... GMP 234 2013 01.2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP....2.2 Renneted milk (plain) GMP 01.4.1 Pasteurized cream (plain) GMP 01.4.2 Sterilized and..., crustaceans, and echinoderms GMP 10.2.1 Liquid egg products GMP 2013 10.2.2 Frozen... toppings) GMP 12.1.2 Salt Substitutes GMP 13.1.2 Follow-up formulae GMP 13.2 Complementary...



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0.16/5
... objectives ............................................................................ 16 3.2 Good Medical Practice - GMP...................................................................................... 16 3.3 Syllabus .............................................................................................................................. 17 3.3.1 Common Competences... http://www.enlightenme.org/ GMP domain headings GMP 1 GMP 2 GMP 3 GMP 4 Knowledge, skills and performance... and preventative indications Assessment Methods GMP Domains Recall indications, contraindications, side... communicable diseases Knowledge Assessment Methods GMP Domains Understand the principles of... findings appropriately Knowledge Assessment Methods GMP Domains Understand the different methods... with appropriate assessments Assessment Methods GMP Domains C, TO 1 Identification of learning... healthcare provision Knowledge Assessment Methods GMP Domains Understand the guidance given... organise further investigations Assessment Methods GMP Domains Identify physiological perturbations causing... UK Resuscitation Council Assessment Methods GMP Domains E, C, Mi, ACAT 1 Demonstrate familiarity... initiate immediate management Assessment Methods GMP Domains Identify physiological perturbations that... implement a management plan Assessment Methods GMP Domains E, C, Mi, ACAT 1 Specify abdominal... implement a management plan Assessment Methods GMP Domains Characterise the different types... implement a management plan Assessment Methods GMP Domains Recall cardiac electrophysiology relevant... implement a management plan Assessment Methods GMP Domains Recall the characteristic lesions... clinical examination Knowledge Assessment Methods GMP Recognises the importance of different... and often conflicting agendas A,D 1 175 GMP 3,4 1,3 B) Clinical Examination This training will... appropriate or required A,C 3,4 Assessment Methods GMP A,D 1 A,C,D 2,4 D 1 A,D 1 Competence Description CE_BK_01 Skills Competence... consent for anaesthesia Knowledge Assessment GMP Methods Competence Description OA_BK_01 Knows... for consent 178 Skills Assessment GMP Method Competence Description Demonstrates satisfactory... using prophylactic antibiotics A,C,E 1 Assessment Method GMP Skills Competence Description PD_BS_01 Selects... A,C,D,E 2 Skills Competence Description Assessment Methods GMP IG_BS_01 Demonstrates safe practice in... Knowledge Competence Description Assessment Method GMP PO_BK_01 Lists the equipment required... ward after surgery A,C,E 1,2,3 Assessment Method GMP A,D 1 Skills Competence Description Demonstrate appropriate... inhalational induction of anaesthesia A,C,D,E 1,2 A,C,D,E 1,2 Methods GMP In respect of tracheal intubation... manual jet ventilation A,C,E 1,2 Assessment Methods GMP A,D,E 1 A,C,E 1 Skills Competence Description AM_BS_01 Demonstrates...] Knowledge Competence Description Assessment Methods GMP PA_BK_01 Recalls/explains the relevance...-pharyngeal and LMAs] A,C,E 1,2 Assessment Methods GMP Skills Competence Description PA_BS_04 Demonstrates... Knowledge Competence Description Assessment Methods GMP A,C,E 1,2,3,4 Discusses the special problems encountered... of gastric reflux A,C,E 1 Assessment Methods GMP A,C,D 1,2,3,4 A,C,D,M 1,2,3,4 A,D 1 Skills Competence Description ES_BS_01 Manages... Knowledge Competence Description Assessment Methods GMP TF_BK_01 Explains the importance of... the transfer team A,C,E 1,2 Assessment Methods GMP Skills Competence Description TF_BS_01 Demonstrates... Knowledge Competence Description Assessment Methods GMP A,D,E 1,2,3 Can explain  CS_BK_01 What is... techniques in children A,C,E 1,2,3 Assessment Method GMP Skills Competence Description CS_BS_01 Demonstrates... regional blockade A,C,E 1,2,3,4 Assessme nt Method GMP Skills Compete nce Description RA_BS_01... control measures) Knowledge Assessment Methods GMP Domains Demonstrates knowledge of venous... anaesthesia where appropriate Assessment Methods GMP Domains Demonstrates knowledge of anatomy... interpret the results Assessment Methods GMP Domains E, C, M, ACAT, 1 Demonstrates knowledge of... monitor respiratory function Assessment Methods GMP Domains C, D, Mi 1 ACAT, D, C, Mi 1 C, Mi... and appropriate investigation Assessment Methods GMP Domains E, Mi, C, ACAT 1 E, Mi, C, ACAT... achieving diagnosis E, ACAT, AA, C, Mi GMP Domains 1 Understand the pathophysiology, classification... organise further investigations Assessment Methods GMP Domains Recognises the common causes...-respiratory arrest Knowledge Assessment Methods GMP Domains E, Mi, C, ACAT 1 E, Mi, C, ACAT... implement a management plan Assessment Methods GMP Domains E, Mi, C, ACAT 1 Mi, C, D 1 Identify... an ultrasound system Assessment methods GMP Domains C, AA, W 1 D 1 E, C 2, 3 Types of transducers...-uterine pouches Assessment Methods GMP Domains E, C, W 1 D 1 E, C 2, 3 Assessment Methods GMP Domains E, C, W 1 Heart and... adequate images D 1 E, C 2, 3 ST4-6 Assessment Methods GMP Domains Use focused ultrasound to... adequate images D 1 E, C 2, 3 ST4-6 Assessment Methods GMP Domains Knows vascular anatomy E, C, AA...



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...@intechopen.com 7 Good Manufacturing Practices (GMP) for Medicinal Products Jaya Bir... Limited Nepal 1. Introduction The term GMP was introduced to regulate manufacturing... detailed European Community guidelines on GMP. The Medicines and Healthcare products... storage of finished pharmaceutical products. GMP regulations were developed by the... pharmaceutical products. Effective implementation of GMP would also provide the cost... operations. 3. Good Manufacturing Practices (GMP) guidelines GMP is a production and testing practice... devices or active pharmaceutical products GMP guidelines are not prescriptive instructions... the World Health Organization recommended GMP (WHO GMP) for pharmaceutical products. Regional... Inspection Convention (PIC)—guide to GMP for pharmaceutical products—Australia, Austria... South-East Asia Nations (ASEAN)—GMP: general guidelines—Brunei Darussalaam, Cambodia....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products c. 105 European... European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does... others having highly developed/sophisticated GMP requirements. In the United Kingdom... Manufacturers and Distributors. In general, GMP inspections are performed by national... marketing (Wikipedia, 2012a). 4. Components of GMP GMP requires that the manufacturing process....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 107 Documentation... 2. Quality Assurance 3. Good Manufacturing Practice (GMP) for Medicinal Products 4. Quality Control... Personal Hygiene Good Manufacturing Practices (GMP) Components 9. Self-Inspection, Quality Audits....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 109 products... with reference to above mentioned GMP statements. 4.1 Quality management The holder... specified in a written form and GMP requirements are adopted; (c) managerial responsibilities.... 4.3 Good Manufacturing Practice (GMP) for medicinal products GMP is that part of... marketing authorizations or product specification. GMP is aimed primarily at diminishing... containers. The basic requirements of GMP are that: (a) all manufacturing processes....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 115 4.6.1 Validation....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 117 COMPLAINT... can evaluate the implementation of GMP objectively. Management appoints a self-inspection....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 121 Manufacturing...: Sharp, 2005) Name GI/1 GI/2 GMP/1 GMP/2 GMP/3 GMP/4 Fig. 9. Company Training Record (Source....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 127 brackets....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 129 4.11....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products      131 For....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 133 Between....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 137 specifically... received (Materials Delivery Record). The GMP requirements agree that received materials... used to manage and record GMP compliance: instructions (directions, requirements) and....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 2. 3. 4. 5. 6. 139 To... activities, e.g., environmental monitoring of the GMP facility. Logbooks: Bound collection of....1 Hierarchical document system A company’s controlled GMP document system should be established... Promising Pharmaceuticals Regulations (USFDA/EU GMP/WHO GMP) S P E C I F I C I T Y Quality Manual Level 1 Company... for following (e.g., USFDA/EU GMP/ICH/WHO GMP/Schedule M, etc.) should be... on developing, documenting, and implementing a GMP-compliant quality system. The next....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 141 instructions....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products c. d. e. f. g. h. i. 143 Identification....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 145 increase... practical implementation of GMP. The effective implementation of GMP requires extensive care... for Implementation of GMP, (Edition 2000), Indonesian National GMP Team ASEAN Chaloner... guide to good manufacturing practice (GMP) requirements, World Health Organization, Geneva...). EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, 23.03.2012, Huber....intechopen.com Good Manufacturing Practices (GMP) for Medicinal Products 147 Nally, J., & Kieffer, RG. (1998). GMP Compliance, Productivity and Quality. Ch.... (2011). Documentation and records: Harmonized GMP requirements. Journal of Young Pharmacists....in/html/GMP/ScheduleM(GMP).pdf Sharp, J. (1991). Wider aspects of GMP. Good....) (2005). Good Design Practices for GMP Pharmaceutical Facilities, Taylor & Francis Group... Karmacharya (2012). Good Manufacturing Practices (GMP) for Medicinal Products, Promising Pharmaceuticals.../promising-pharmaceuticals/good-manufacturing-practices-gmp-formedicinal-products InTech Europe University...