good manufacturing requirements for active pharmaceutical ingredients

... HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS At ... 39 Trang 7GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS 1 INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing ... (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality It is also intended to help ensure that APIs meet the requirements for quality

Ngày tải lên: 04/12/2017, 04:18

... the requirements for a good English-Vietnamese / Vietnamese -English interpreter and translator. It was found that the common requirements for a good interpreter and translator are: having good ... passion for their jobs 282.1.4 Great intellectual curiosity and ability to use various 29 information-providing sources effectively 2.2 Particular requirements for a good interpreter 30 2.2.1 Good ... HO CHI MINH CITY UNIVERSITY OF FOREIGNLANGUAGES -INFORMATION TECHNOLOGY GRAD ATION PAPER REQUIREMENTS FOR A GOOD INTERPRETER AND TRANSLATOR & SO E SUGGESTIONS FOR HUFLIT STUDENTS MAJORING IN

Ngày tải lên: 01/09/2023, 22:14

... Particular requirements for low-voltage switchgear and controlgear assemblies intended to be installed in places where unskilled persons have access for their use - Distri bution boards FOREWORD ... supplementary requirements for such enclosed distribution boards (DBU), which are stationary, type tested assemblies (TTA) for indoor use, containing protective devices and intended for use either ... 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, 11:06

... Part 4: Particular requirements for assemblies for construction sites (ACS) FOREWORD 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization ... provided by enclosures (IP Code) Isolating transformers and safety isolating transformers - Requirements I 60755 (1 983): General requirements for residual current operated protective devices ... dioxide test for contacts and connections Power transformers Plugs, socket-outlets and couplers for industrial purposes Electrical installations of buildings, Part 4: Protection for safety -

Ngày tải lên: 25/12/2013, 11:07

... Part 5: Particular requirements for assemblies intended to be installed outdoors in public places - Cable distribution cabinets (CDCs) for power distribution in networks FOREWORD The IEC ... distribution cabinet for installation on a pole, on which a transformer is normally mounted, in an aerial network The cabinet entries for external conductors are suitable for cables or insulated ... way to a mechanical force before the transmitted force to the CDC enclosure reaches the value which would adversely affect the degree of protection (IP code) 7.1.3 Terminals for external conductors

Ngày tải lên: 25/12/2013, 11:08

... base Trang 16 2 Accounting and auditing requirements for SMEs Introduction 2.1 The rationale for simplifying the financial reporting requirements for SMEs is the need to reduce regulatory ... requirements for SMEs When the financial reporting options for SMEs were first introduced in the UK, the thresholds were set at a lower level than the EU maxima, and the turnover threshold for ... Comparison of the size selection criteria for the two studies 25 4.5 Spearman’s correlation matrix for ownership, size and age 29 4.7 Spearman’s correlation matrix for age, size and financial 4.9 Services

Ngày tải lên: 18/02/2014, 01:20

... leading to the termination of the scheme;  Other information which is necessary for investors to make an informed judgement. Trang 94 Considerations for Overseas SchemesPlace of Establishment of the ... stipulates the specific requirements on unit trusts and mutual funds. Trang 52 Authorisation Process• A collective investment scheme applying for an SFC authorisation for public distribution ... (express or implied) is given as to the accuracy or completeness of the information contained Contact For more information about our services, please feel free to contact the following person

Ngày tải lên: 19/02/2014, 14:20

... proteasecore Therefore, we conclude that these domains are important for catalysis A contribution for the TRAF-like domain should not be neglected, but the most important support for substrate processing ... ubiquitin-like proteins They are responsible for the disassembly of ubiquitin chains, and for the cleavage of mono- and oligomers of this mole-cule, either in precursor form or attached to small Keywords ... used for the titrations should be considered as approximate figures. Trang 8the enzyme–substrate complexes were more stable inthe context of an intact C-terminal region Structural requirements for

Ngày tải lên: 07/03/2014, 05:20

... Michael Garrett, for truth and insight in the midst of chaos Seth Piercy, for unwavering strength and support Robert Reedy, for teaching me how to see myself with humor and still to make good art Mark ... afriend needed to borrow it For about the next year I was without the book, but I believe it was for the better Mary’s work had such an impact on me, I think it was good for me to be working with ... for showing me that a woman could be tenacious well into her 70’s with her chain-saw sculptures The Carroll Reece Museum, Blair White, and all the folks working there My mother, for keeping good

Ngày tải lên: 07/03/2014, 13:20

... ensure its potential feed quality Supplementation requirements for optimum use of low digestibility forages by ruminants For efficient digestion of forage, irrespective of its content of solubles, ... arises for immature animals on poor quality forage, to what extent can growth be increased by providing nutrients for the rumen and extra protein for absorption? The provision of more protein for ... overall digestibility of forage by up to 10 units and also reduce the need for supplemental minerals and urea for its efficient fermentative digestion Thus managing the harvest of forage is critical

Ngày tải lên: 08/03/2014, 23:20

... Regulatory rules text on the capital requirements for bank exposures to central counterparties The interim framework for determining capital requirements for bank exposures to central counterparties ... definition In addition, for a CCP to be considered a QCCP, the terms defined in paragraphs 122 and 123 of this Annex for the purposes of calculating the capital requirements for default fund exposures ... set forth in Basel II for collateralised transactions.4 Where the respective exposure methodology allows for it, margining can be taken into account In the case of IMM banks, the 20-day floor for

Ngày tải lên: 15/03/2014, 10:20

... INFORMATION EXCHANGE BETWEEN A CERTIFICATION BODY AND ITS CLIENTS 8-1  9  PROCESS REQUIREMENTS 9-1  10  MANAGEMENT SYSTEM REQUIREMENTS FOR CERTIFICATION BODIES 10-1  ANNEX A SECURITY (INFORMATIVE) ... offering audit and certification for general types of management systems However, for each specific type of system, specific additional requirements will be needed, for example, to specify the standard ... 17021, Conformity Assessment—Requirements for Bodies Providing Audit and Certification of Management Systems (reference [5]) is an International Standard which sets out criteria for bodies

Ngày tải lên: 15/03/2014, 23:20

... C-terminal carboxylate forms a salt bridge with R188e, the latter two inter-actions involving a symmetry-related molecule The enzyme used for crystallization was in an inactive form, with the catalytic ... residues, where a conformational change is responsible for adjustment of the inhibitor to the enzyme in the b-sheet-forming motif The C-terminus has a relatively stable conformation, although ... the model C1 family cysteine protease and one of only two enzymes in the family for which structural infor-mation for a cystatin complex is available [23,24] Based on the amino acid sequence and

Ngày tải lên: 16/03/2014, 04:20

... order to determine the amino-terminal sequence requirements for protein N-myristoylation, site-directed mutagenesis of the N-terminal region was performed using tumor necrosis factor (TNF) mutants ... critical for protein N-myristoylation Sequential vertical-scanning mutagenesis of amino acids at a distinct position in this model N-terminal sequence revealed the major sequence requirements for ... incubation for 5 h at 37C, the cells were re-fed with serum-containing medium and incubated again at 37C for 24 h The cells were then washed twice with 1 mL of serum-free DMEM and incubated for 5

Ngày tải lên: 16/03/2014, 16:20

... this effort, the war against prescription opiate abuse continues to soar As the epidemic of prescriptions for opiates increases, so do the efforts to develop specific educational strategies for ... health care costs for opioid abusers were more than eight times higher than for nonabusers The total average health care cost for opioid abusers was $15,884 compared to $1,830 for nonabusers The ... around further research directed at mandatory educational requirements for primary care providers and pharmacists and increasing funding for a national prescription monitoring program, the National

Ngày tải lên: 17/03/2014, 06:20

... This publication contains information about federal laws and equipment carriage requirements for recreational vessels of the United States It is important that you understand that federal equipment requirements ... Coast Guard Navigation Rules, International-In-land, specifies lighting requirements for every description of watercraft The information provided below is for power-driven and sailing vessels less than 65 5 feet (20 meters) in length ... it is recommended that the extinguish-Extinguisher markings can be confusing because one extinguisher can be approved for several different types of fires (A, B, or C) For example, an extinguisher marked “Type A, Size II; Type B; C, Size I” is acceptable as a Type B-I extinguisher Look for the section of the label that states “Marine Type USCG, Type

Ngày tải lên: 17/03/2014, 14:20

... – 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

... 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

... 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