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Download or read book WHO Training Modules on GMP written by and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Basic Training Modules on GMP written by and published by . This book was released on 2001 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9789241547147
Total Pages : pages
Book Rating : 4.5/5 (471 download)
Download or read book WHO Training Modules on Good Manufacturing Practices (GMP) written by and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Chandrasekhar Panda
Publisher :
ISBN 13 : 9789354583056
Total Pages : 0 pages
Book Rating : 4.5/5 (83 download)
Download or read book Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products written by Chandrasekhar Panda and published by . This book was released on 2021-07-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book contains 11 Modules of Good Manufacturing Practices (GMP) for Pharmaceutical Products which will be very useful to the persons working in Pharmaceutical Industry and this can be used as a cGMP Training modules in Pharmaceutical Companies which is a basic training requirement for every employee. The Modules are Module-1 Plant Premises Module-2 Plant Equipment's Module-3 Plant Production Module-4 Plant Personnel Module-5 Plant Training, Documentation and Personnel Hygiene Module-6 Plant Quality Control Module-7 Qualification and Validation Module-8 Pharmaceutical QMS Module-9 Plant Self-Inspection and Audit Module-10 Plant Complaints and Product recall Module-11 Plant Contract Manufacturing and Contract Analysis
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 143985016X
Total Pages : 484 pages
Book Rating : 4.4/5 (398 download)
Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2016-04-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Author : Daniel Farb, M.D.
Publisher : Universityofhealthcare
ISBN 13 : 9781594910265
Total Pages : 258 pages
Book Rating : 4.9/5 (12 download)
Download or read book GMP Training Package, Manual and CD written by Daniel Farb, M.D. and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241209291
Total Pages : 153 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2005-11-11 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Important topics were addressed such as regulatory guidance on interchangeability of medicines fix-dose combinations: how to regulate them new guidance in the area of good manufacturing practices (GMP) and stability testing and counterfeit medicines. In addition some 12 new monographs for antiretrovirals 6 new ones on TB drugs including 2- 3- and 4-fixed-dose preparations as well as monographs for antimalarial medicines are discussed in detail. Seven new specifications for antiretrovirals were adopted. The report also includes newly International Chemical Reference Substances for the series of artemisinin derivatives. The following new WHO guidelines were adopted and are annexed to the report: GMP: requirement for the sampling of starting materials (amendment to current text) GMP: water for pharmaceutical use guideline for sampling of pharmaceuticals and related materials guidelines for registration of fixed-dose combination medicinal products.
Author :
Publisher :
ISBN 13 : 9789241548588
Total Pages : 0 pages
Book Rating : 4.5/5 (485 download)
Download or read book Quality Assurance of Pharmaceuticals written by and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious, falsified and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. More than 70 relevant documents endorsed by the Committee are reproduced in this CDROM, providing guidance covering all aspects of quality assurance including good manufacturing practices (GMP). This CD-ROM replaces and updates the Compendium of Guidelines and Related Materials published in 2010 and also includes the WHO Training Modules on Good Manufacturing Practices (GMP) study pack with a huge set of training materials reflecting the various GMP texts.
Author : Karura Ndicu-Stevens
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (139 download)
Download or read book Creating Role Models written by Karura Ndicu-Stevens and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology companies are required to ensure all personnel are trained to perform tasks associated with their jobs. Traditional methods typically involve standard operating procedures (SOPs), on-the-job training (OJT) and instructor-led training (ILT). Training methods for the use of a Manufacturing Execution System (MES) include SOPs and ILTs but could be improved to provide more hands-on exercises. Using adult learning theory and instructional design, training methods can be created to ensure they are engaging, interactive and effective. This study utilized instructional design models ADDIE and SAM to develop a training template which was then used to create interactive and engaging training modules for the MES system. Improving training methods can allow for more efficiencies, lower potential human-related errors and defects and increase workforce capabilities within a short period of time. Standardized templates offer a level of confidence when creating training as it often leads to higher levels of repeatability and consistent outcomes.
Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations
Publisher : World Health Organization
ISBN 13 : 9241209860
Total Pages : 401 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations and published by World Health Organization. This book was released on 2014 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.
Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting
Publisher : World Health Organization
ISBN 13 : 9241209925
Total Pages : 224 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting and published by World Health Organization. This book was released on 2015-05-11 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs general texts and ICRS. It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP) and was informed of progress achieved with developing a comprehensive document on GPhP through discussions at consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP) distribution and trade of pharmaceuticals and regulatory practice. It adopted eight guidelines and 16 technical supplements as listed below including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project. The report includes the following annexes which are recommended as new WHO guidelines: . Annex 1. Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision); . Annex 2. Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia (revision); . Annex 3. Supplementary guidelines on good manufacturing practices: validation; Appendix 7: non-sterile process validation (revision); . Annex 4. General guidance for inspectors on hold-time studies (new); . Annex 6. Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision); . Annex 7. Guidelines on registration requirements to establish interchangeability (revision); . Annex 8. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision); . Annex 9: Good review practices guidelines for regulatory authorities (new). In addition 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were adopted for publication in a format which is appropriate to the large volume of this guidance (Annex 5). The newly adopted monographs were adopted for inclusion in The International Pharmacopoeia. Following the implementation of the revised general monograph on parenteral preparations the Committee adopted the proposed endotoxin limits for 11 parenteral dosage form monographs lacking such specification together with related updates to relevant monographs. The Committee adopted 12 ICRS newly characterized by the custodian centre EDQM. The Committee further adopted the workplan for new monographs to be included in The International Pharmacopoeia.
Author : Joseph D. Nally
Publisher : CRC Press
ISBN 13 : 1420020935
Total Pages : 418 pages
Book Rating : 4.4/5 (2 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241209488
Total Pages : 151 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2008-05-05 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards standards and guidelines for medicines' quality assurance. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph. Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antituberculosis, antiretroviral and specifically also medicines for children. The main principles for selection of INNs for biologicals were endorsed. In order to serve the WHO-managed Prequalification Program, two new procedures were adopted, namely on prequalification of intrauterine devices (IUDs) and of male latex condoms, together with a new guidance on the assessment of active pharmaceutical ingredients for use in medicines.--Publisher's description.
Author : C.Th. Smit Sibinga
Publisher : Springer Science & Business Media
ISBN 13 : 1461526086
Total Pages : 293 pages
Book Rating : 4.4/5 (615 download)
Download or read book Good Manufacturing Practice in Transfusion Medicine written by C.Th. Smit Sibinga and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: TQM AND TAYLORISM; HOW THEY COMPARE H. Bremer Preface The industrial world today is divided between two camps: a culture based on the principles of Total Quality Management (TQM), developed in the Far East, and one still strongly influenced by the origins of "Scientific Management", intro duced in the West by F.W. Taylor and others at the turn of the century. This divergence will be shown to have arisen in the last forty years, long enough for a new generation of managers and corresponding culture to emerge. The two cul tures are so deeply entrenched that it is difficult for one to change to the other. However, there is strong evidence to support the contention that people-oriented TQM is superior, and those companies clinging to Taylor models now face diffi cult decisions. Actions by Taylor-companies to move to TQM rnight weH be hindered rather than helped by applying present Quality Assurance Standards, developed by Taylor-oriented national and international Standards Institutions.
Author : Mark Allen Durivage
Publisher : Quality Press
ISBN 13 : 1951058909
Total Pages : 404 pages
Book Rating : 4.9/5 (51 download)
Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Author : Anthony Luttrell
Publisher : Universityofhealthcare
ISBN 13 : 9781594910371
Total Pages : 61 pages
Book Rating : 4.9/5 (13 download)
Download or read book Pharmaceutical Quality Control Lab written by Anthony Luttrell and published by Universityofhealthcare. This book was released on 2004 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with out of standard and out of trend results in a pharmaceutical quality control lab. It contains an interactive flow chart, numerous step -by-step instructions, questions, an SOP model, and a case study. It is suitable for GMP training. Estimated time: 2-5 hours. 199 pages on CD. 61 pages in the manual include a handy printout of the FDA regulations part 210 and part 211. For convenience, the CD contains the text of some of the regulations. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
Author : Frank Cicero, PMP
Publisher : HIMSS
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4./5 ( download)
Download or read book Good Informatics Practices (GIP) Module: Validation & Verification written by Frank Cicero, PMP and published by HIMSS. This book was released on 2011 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:
