Good Manufacturing Practice (GMP) Guidelines

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Author :
Publisher : Pharmalogika
ISBN 13 : 9780982147603
Total Pages : 686 pages
Book Rating : 4.1/5 (476 download)

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Book Synopsis Good Manufacturing Practice (GMP) Guidelines by : Mindy J. Allport-Settle

Download or read book Good Manufacturing Practice (GMP) Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.

Eudralex - The Rules Governing Medicinal Products in the European Union

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Author :
Publisher :
ISBN 13 : 9780119853667
Total Pages : 195 pages
Book Rating : 4.8/5 (536 download)

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Book Synopsis Eudralex - The Rules Governing Medicinal Products in the European Union by : European Communities Commission, Directorate-General for Industry, Pharmaceuticals and Cosmetics

Download or read book Eudralex - The Rules Governing Medicinal Products in the European Union written by European Communities Commission, Directorate-General for Industry, Pharmaceuticals and Cosmetics and published by . This book was released on 1999-07-02 with total page 195 pages. Available in PDF, EPUB and Kindle. Book excerpt: A series governing medicinal products in the European Union. There are three volumes on products for human use, three (including these volumes) on veterinary products and one covering both. These guidelines address general, efficacy and environmental risk assessment, immunologicals and quality.

Eudralex - The Rules Governing Medicinal Products in the European Union

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Author :
Publisher : Stationery Office Books (TSO)
ISBN 13 : 9780119853513
Total Pages : 340 pages
Book Rating : 4.8/5 (535 download)

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Book Synopsis Eudralex - The Rules Governing Medicinal Products in the European Union by : Directo European Communities Comm

Download or read book Eudralex - The Rules Governing Medicinal Products in the European Union written by Directo European Communities Comm and published by Stationery Office Books (TSO). This book was released on 1999-05-01 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: A series governing medicinal products in the EU. There are three volumes covering products for human use, three (including this one) covering veterinary products and one covering both. These volumes address procedures for marketing authorization and the presentation and content of dossiers.

The rules governing medicinal products in the European Union : EudraLex. 5. Pharmaceutical legislation : veterinary medicinal products

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Author :
Publisher :
ISBN 13 : 9789282820377
Total Pages : 275 pages
Book Rating : 4.8/5 (23 download)

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Book Synopsis The rules governing medicinal products in the European Union : EudraLex. 5. Pharmaceutical legislation : veterinary medicinal products by : European Commission

Download or read book The rules governing medicinal products in the European Union : EudraLex. 5. Pharmaceutical legislation : veterinary medicinal products written by European Commission and published by . This book was released on 1998 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Rules Governing Medicinal Products in the European Union

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Author :
Publisher :
ISBN 13 : 9789282824375
Total Pages : 407 pages
Book Rating : 4.8/5 (243 download)

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Book Synopsis The Rules Governing Medicinal Products in the European Union by :

Download or read book The Rules Governing Medicinal Products in the European Union written by and published by . This book was released on 1998 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Guidelines: Medicinal Products for Human Use

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Author :
Publisher :
ISBN 13 : 9789282824382
Total Pages : 248 pages
Book Rating : 4.8/5 (243 download)

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Book Synopsis Guidelines: Medicinal Products for Human Use by : European Commission

Download or read book Guidelines: Medicinal Products for Human Use written by European Commission and published by . This book was released on 1998 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Rules Governing Medicinal Products in the European Union

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Author :
Publisher : Bernan Press(PA)
ISBN 13 : 9789282824368
Total Pages : 0 pages
Book Rating : 4.8/5 (243 download)

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Book Synopsis Rules Governing Medicinal Products in the European Union by : European Communities

Download or read book Rules Governing Medicinal Products in the European Union written by European Communities and published by Bernan Press(PA). This book was released on 1997 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examine the rules governing medicinal products for use in Europe, in this five volume collection. Volume I contains rules governing medicinal products for human use; Volume II provides notice to applicants for marketing authorizations and includes 2 disks; Volume III presents guidelines on quality, safety, and efficacy of medicinal products for human use; Volume IV is a guide to good manufacturing practices for medicinal products for human and veterinary use; Volume V contains rules governing medicinal products for veterinary use.

The Rules Governing Medicinal Products in the European Union

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Author :
Publisher : Bernan Press(PA)
ISBN 13 :
Total Pages : 304 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis The Rules Governing Medicinal Products in the European Union by : European Commission

Download or read book The Rules Governing Medicinal Products in the European Union written by European Commission and published by Bernan Press(PA). This book was released on 1998 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: A series governing medicinal products in the European Union. There are three volumes (including this one) covering products for human use, three covering veterinary medicinal products and one covering both. The volumes consist of legislation, notice to applicants, guidelines and good practice.

The Rules Governing Medicinal Products in the European Union

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Author :
Publisher : Bernan Press(PA)
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis The Rules Governing Medicinal Products in the European Union by : Commission of the European Communities

Download or read book The Rules Governing Medicinal Products in the European Union written by Commission of the European Communities and published by Bernan Press(PA). This book was released on 1998 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide is presented in chapters, each headed by a principle of GMP, outlining the Quality Assurance objectives of that chapter.

The Rules Governing Medicinal Products in the European Union

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Author :
Publisher :
ISBN 13 :
Total Pages : 300 pages
Book Rating : 4.:/5 (53 download)

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Book Synopsis The Rules Governing Medicinal Products in the European Union by : European Commission

Download or read book The Rules Governing Medicinal Products in the European Union written by European Commission and published by . This book was released on 1998 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:

EudraLex: B: presentation and content of the dossier

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Author :
Publisher :
ISBN 13 : 9789282843413
Total Pages : pages
Book Rating : 4.8/5 (434 download)

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Book Synopsis EudraLex: B: presentation and content of the dossier by :

Download or read book EudraLex: B: presentation and content of the dossier written by and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Establishment by the European Community of maximum residue limits (MRLs) for residues of veterinary medicinal products in foodstuffs of animal origin

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Author :
Publisher :
ISBN 13 : 9789282631737
Total Pages : 148 pages
Book Rating : 4.6/5 (317 download)

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Book Synopsis Establishment by the European Community of maximum residue limits (MRLs) for residues of veterinary medicinal products in foodstuffs of animal origin by : European Communities Commission

Download or read book Establishment by the European Community of maximum residue limits (MRLs) for residues of veterinary medicinal products in foodstuffs of animal origin written by European Communities Commission and published by . This book was released on 1991 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Guidelines

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Author :
Publisher :
ISBN 13 : 9789282857458
Total Pages : 331 pages
Book Rating : 4.8/5 (574 download)

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Book Synopsis Guidelines by : Comisión Europea

Download or read book Guidelines written by Comisión Europea and published by . This book was released on 1999 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceuticals in the European Union

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Author :
Publisher :
ISBN 13 :
Total Pages : 46 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Pharmaceuticals in the European Union by : European Commission. Enterprise DG.

Download or read book Pharmaceuticals in the European Union written by European Commission. Enterprise DG. and published by . This book was released on 2000 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ensuring the Integrity of Electronic Health Records

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Author :
Publisher : CRC Press
ISBN 13 : 1000223035
Total Pages : 203 pages
Book Rating : 4.0/5 (2 download)

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Book Synopsis Ensuring the Integrity of Electronic Health Records by : Orlando López

Download or read book Ensuring the Integrity of Electronic Health Records written by Orlando López and published by CRC Press. This book was released on 2020-12-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

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Author :
Publisher : World Scientific
ISBN 13 : 981461680X
Total Pages : 564 pages
Book Rating : 4.8/5 (146 download)

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Book Synopsis Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals by : Huss Ralf

Download or read book Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals written by Huss Ralf and published by World Scientific. This book was released on 2015-09-23 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

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Author :
Publisher : CRC Press
ISBN 13 : 1315349973
Total Pages : 268 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Data Integrity in Pharmaceutical and Medical Devices Regulation Operations by : Orlando Lopez

Download or read book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations written by Orlando Lopez and published by CRC Press. This book was released on 2016-11-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.