good manufacturing requirements for active pharmaceutical ingredients
The challenges for implementation of good manufacturing practices by local pharmaceutical manufactures in vietnam
... – Good Manufacturing Practices, GLP – Good Laboratory Practices, GSP – Good Storage Practices, GDP – Good Distribution Practices, and GPP – Good Pharmacy Practices) in quality assurance for pharmaceutical ... CFR Good Manufacturing Practices World Health Organization U.S Food and Drug Administration Good Laboratory Practices Good Storage Practices Good Distribution Practices Good Pharmacy Practices Good ... the other four good practices are explained hereunder Quality Assurance in Pharmaceutical Industry Quality Assurance of Pharmaceutical products GMP Good Manufacturing Practices GLP Good Laboratory...
Ngày tải lên: 06/11/2012, 10:26
Microfluidic methods for the crystallization of active pharmaceutical ingredients
... steps of active pharmaceutical ingredients (APIs), signified by the fact that ∼90 % of all APIs are formulated as crystals The outcome of crystallization is ideally a population of uniform particles ... downstream processing steps in the manufacturing of active pharmaceutical ingredients (APIs) [16] Its importance is signified by the fact that more than 90% of APIs are formulated as crystals [17] Ideally, ... of SA formation Fortunately, such platforms already exist, and are extensively used for the precise execution of unit operations both in academia and industry An overview of these platforms,...
Ngày tải lên: 09/09/2015, 11:29
Investigations on co milling of active pharmaceutical ingredients
... Co-milling of Active Pharmaceutical Ingredients SUMMARY Milling is commonly used in pharmaceutical secondary manufacturing for reducing particle size of crystalline active pharmaceutical ingredients ... bioavailability for an increasing range of pharmaceutical applications This Chapter Introduction formulation aspect affects performance of a pharmaceutical product It governs for instance, sedimentation ... 153 xv Investigations on Co-milling of Active Pharmaceutical Ingredients LIST OF ABBREVIATIONS AA Adipic acid AA-2G Ascorbic acid 2-Glucoside API Active Pharmaceutical Ingredient Ball-milled Milled...
Ngày tải lên: 11/09/2015, 10:06
Understanding dynamics in thin film spherical crystallization of active pharmaceutical ingredients from microfluidic emulsion
... Introduction 1.1 Pharmaceutical Manufacturing Manufacturing in the pharmaceutical industry accounts for almost a third of the total costs, with expenses exceeding that of R&D[1], and therefore, draws ... polymorphic form) to eliminate the need for costly downstream dry milling and grinding in industry settings It paves a way for designing novel continuous crystallizers for industrial scale manufacturing ... appears to be an attractive platform for simultaneous control over both polymorphism and crystal size/shape It en11 able an alternative route for downstream processing in pharmaceutical industry,...
Ngày tải lên: 30/09/2015, 10:11
Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance pdf
... reasons for this hesitancy Nonetheless, industry's hesitancy to broadly embrace innovation in pharmaceutical manufacturing is undesirable from a public health perspective Efficient pharmaceutical manufacturing ... availability of safe, effective, and affordable medicines Pharmaceuticals continue to have an increasingly prominent role in health care Therefore pharmaceutical manufacturing will need to employ ... should be used for gaining process understanding and can also be used to meet the regulatory requirements for validating and controlling the manufacturing process Quality is built into pharmaceutical...
Ngày tải lên: 18/03/2014, 00:20
báo cáo hóa học:" A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice" docx
... the quality requirements therein described The European Regulation is also clear on requiring that all ATMP have to be prepared according to the good manufacturing practice (GMP) for medicinal ... Pharmacopoeia; for noncompendial items and new drugs, the endotoxin limit should be calculated by the user The Maximum Valid Dilution (MVD) provides an upper bound for dilution that still provides for endotoxin ... in vivo assays Cells were evaluated for hemat- Page of (page number not for citation purposes) Journal of Translational Medicine 2009, 7:78 opoietic colony-forming unit (CFU), and assessment of...
Ngày tải lên: 18/06/2014, 15:20
A research proposal submitted in partial fulfillment of the requirements for the degree of Master of Business Administration
... consumers look to for purchasing advice? Does this differ by good or service category? How can the retailer appeal to opinion leaders? Social performance - Are customers high or low performers? How ... very convenience for busy working people (3.41) and goods in the stores are often unique Whereas customers showed strong disagreement for prestige (1.96) and fashion as reasons for people to go ... convenience for busy working people 3.05 11.4 • Goods in supermarkets are often unique 2.84 9.1 • Going to supermarkets is most suitable for buying gifts 2.57 6.8 • Supermarkets are only for people...
Ngày tải lên: 13/04/2013, 10:30
BUILDING CODE REQUIREMENTS FOR STRUCTURAL CONCRETE (ACI 318-99) AND COMMENTARY
... profile Deformed reinforcement — Deformed reinforcing bars, bar mats, deformed wire, welded plain wire fabric, and welded deformed wire fabric conforming to 3.5.3 Deformed reinforcement — Deformed ... only for spiral reinforcement (either as lateral reinforcement for compression members, for torsion members, or for confining reinforcement for splices) 3.5.4.2 — Plain wire for spiral reinforcement ... mats for concrete reinforcement shall conform to “Specification for Fabricated Deformed Steel Bar Mats for Concrete Reinforcement” (ASTM A 184) Reinforcing bars used in bar mats shall conform...
Ngày tải lên: 03/08/2013, 11:24
Requirements for the Generic Bus Driver Model
... installed on the platform Problems with this method are: • Detection methods used by drivers might conflict with hardware already installed on the platform For example, if a platform has a drill ... load a driver for a function not currently attached to the bus Figure Generic bus driver model when two functions are contained in one device Bus Driver and Device Requirements for a Generic ... meet the requirements of discoverability and multiplexability • Discoverable - If special information is required in descriptors to group interfaces into functions, this is a problem for a generic...
Ngày tải lên: 07/10/2013, 00:20
Requirements for entry
... staff, or care for an elderly or disabled relative, you should come away with a clear and realistic perspective of what illness can mean for patient and for doctor For more information on volunteering ... failed to obtain high grades at first attempt 47 Requirements for entry Three points might be made about applicants who, for no good reason, perform below target at first attempt Firstly, a modest ... of making an 31 Requirements for entry informed personal decision Learning Medicine puts less emphasis on the years in medical school and more on where they lead Personal health requirements and...
Ngày tải lên: 01/11/2013, 09:20
Tài liệu Cabling Standard - TIA 607 - Commercial Building Grounding and Bonding Requirements for Telecommu doc
... 606 for additional labeling requirements Bonding Conductors for Telecommunications Quang Dung Technology Distribution Company Page of ANSI/TIA/EIA 607 Commercial Building Grounding and Bonding Requirements ... Bonding Requirements for Telecommunications Table of Contents OVERVIEW COMPONENTS OF THE TELECOMMUNICATIONS GROUNDING AND BONDING INFRASTRUCTURE Identification Elements Bonding Conductors for Telecommunications ... Bonding Requirements for Telecommunications The Telecommunications Main Grounding Busbar (TMGB) The TMBG serves as: • • the dedicated extension of the building grounding electrode system for the...
Ngày tải lên: 10/12/2013, 02:15
Tài liệu Cable Management Solutions for Active Platforms pdf
... Your Active Equipment Make the most of your active equipment investment Ensure it delivers the performance you need by incorporating high-performance Cable Management Solutions for Active Platforms ... patch cord between active platform and patch panels S – Integrates slack storage for ease of use • Modular cable management for flexibility and easy deployment – Utilizes RiserGuide for “plug and ... impact on your network’s reliability, performance, and cost It also allows for proper thermal airflow ADC’s Cable Management Solutions for Active Platforms provide ample vertical and horizontal...
Ngày tải lên: 10/12/2013, 19:15
Tài liệu Cable Management Solutions for Active Platforms docx
... Your Active Equipment Make the most of your active equipment investment Ensure it delivers the performance you need by incorporating high-performance Cable Management Solutions for Active Platforms ... patch cord between active platform and patch panels S – Integrates slack storage for ease of use • Modular cable management for flexibility and easy deployment – Utilizes RiserGuide for “plug and ... impact on your network’s reliability, performance, and cost It also allows for proper thermal airflow The TrueNet Cable Management Solutions for Active Platforms provide ample vertical and horizontal...
Ngày tải lên: 10/12/2013, 19:15
iec 60269-2-1 low-voltage fuses - supplemetary requirements for fuses for use by authorized perso
Ngày tải lên: 25/12/2013, 10:47
iec 60269-2 low-voltage fuses - supplementary requirements for fuses for use by authorized person
... LOW-VOLTAGE FUSES Part 2: Supplementary requirements for fuses for use by authorized persons (fuses mainly for industrial application) FOREWORD 1) The formal decisions or agreements of the I ... Supplementary Requirements for Fuses for Use by Unskilled Persons (in preparation) 1.1 Scope These supplementary requirements apply to fuses for use by authorized persons Fuses for use by authorized ... Part 1: Second part: - Part 2: General Requirements (Publication 269-1) Supplementary Requirements for Fuses for Use by Authorized Persons (Fuses Mainly for Industrial Application) (Publication...
Ngày tải lên: 25/12/2013, 10:53
iec 60269-4-1 low-voltage fuses - supplementary requirements for fuse-links for the protection of
... – Part 4-1: Supplementary requirements for fuse-links for the protection of semiconductor devices – Sections I to III: Examples of types of standardized fuse-links FOREWORD 1) The IEC (International ... 60269-4: Low-voltage fuses – Part 4: Supplementary requirements for fuse-links for the protection of semiconductor devices and shall comply with the requirements laid down in the relevant sections ... interested National Committees 3) The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports...
Ngày tải lên: 25/12/2013, 10:54
iec 60269-4 low-voltage fuses - supplementary requirements for fuse-links for the protection of s
... (1994) for fusu for use 269-3 (1987) Part 3: Supplmmtay qui-& by unskilled penanr (fusu mainly for hourchdd and similar appiications) 269-3-1 (1994) Part 3-1: Supplementaty requirements for fuses for ... 8.5.5.2 For one of the tests of no and for test no 2a or 5, the recovery voltage shall be maintained at a value of - for a.c., 1O0 O % for fuse-links rated 690 V and higher, and % for other ... 2a and 2b Test arrangements for other kinds of fuse-links are given in IEC 60269-2-1: Supplementary requirements for fuses for use by authorised persons (fuses mainly for industrial application)...
Ngày tải lên: 25/12/2013, 10:55
iec 60364-7-707 electrical installations of buildings - requirements for special installations or
... l'information Electrical installations of buildings `,`,,``,``,,`,``,``,``,``-`-`,,`,,`,`,,` - Part 7: Requirements for special installations or locations Section 707 - Earthing requirements for ... Part : Requirements for special installations or locations Section 707 - Earthing `,`,,``,``,,`,``,``,``,``-`-`,,`,,`,`,,` - requirements for the installation of data processing equipment FOREWORD ... BUILDINGS Part : Requirements for special installations or locations Section 707 - Earthing requirements for the installation of data processing equipment 700.1 Introduction The requirements of...
Ngày tải lên: 25/12/2013, 11:05
iec 60439-2 low-voltage switchgear and controlgear assemblies - particular requirements for busba
... ASSEMBLIES - Part 2: Particular requirements for busbar trunking systems (busways) FOREWORD The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising ... are for information only Busbar trunking systems (busways) shall comply with all requirements of IEC 60439-1, if not otherwise indicated hereinafter and shall also comply with the particular requirements ... than those specified for basic insulation Creepage distance values of reinforced insulation are dimensioned for twice the value of the rated insulation voltage as specified for basic insulation...
Ngày tải lên: 25/12/2013, 11:05