Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2004 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the years, the World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations, originally created to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control for national regulatory and control systems and the implementation of international standards, but for the most part they have only been available in the annexes to various technical reports. In this second of two volumes, those annexes providing guidelines related to good manufacturing practices and to inspection of manufacturers and drug distribution channels have been gathered and revised. Annotation : 2004 Book News, Inc., Portland, OR (booknews.com).

Download or read book Quality assurance of pharmaceuticals a compendium of guidelines and related materials Volume 2 Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.

Download or read book Quality Assurance Of Pharmaceuticals Vol 2 1 Ed written by World Health Organization and published by . This book was released on 2005 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality Assurance of Pharmaceuticals written by and published by . This book was released on 2007 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by . This book was released on 1999-01-01 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specialized good manufacturing practice (GMP) guidelines for the manufacture of herbal medicinal products address manufacture of products from material of plant origin, which may be subject to contamination and deterioration and may vary in its composition and properties. Furthermore, procedures and techniques often used in the manufacture and quality control of herbal medicines, are substantially different from those used for conventional pharmaceutical products. These specialized GMP guidelines were adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its Thirty-fourth meeting and supplement the existing WHO core GMP guidelines. These guidelines were subsequently published in Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials, Volume 2, Good manufacturing practices and inspection. This publication reproduces guidelines related to good manufacturing practices (GMP) and to the inspection of pharmaceutical manufacturing and drug distribution channels. Provides guidance covering all aspects of good manufacturing practices and includes important texts on inspection.

Download or read book Quality assurance of pharmaceuticals written by and published by . This book was released on 1997 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 414 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 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. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

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 2007 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report sets out the recommendations of an international group of experts relating to developments in the quality assurance of medicines and specifications for drug substances and dosage forms. It contains guidelines of direct relevance to the UN Prequalification Programme for Priority Essential Medicines and for quality control laboratories, including procedures governing the assessment of pharmaceutical products for procurement by UN agencies and for assessing the acceptability of quality control laboratories. It also includes discussion regarding several monographs for inclusion in the International Pharmacopoeia, relating to antiretrovirals, including fixed-dose combinations, TB medicines and antimalarial and paediatric medicines.

Download or read book Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

Download or read book Quality Assurance of Pharmaceuticals Good manufacturing practices and inspection written by and published by . This book was released on 2004 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality Assurance of Pharmaceuticals WHO good manufacturing practices starting materials written by and published by . This book was released on 2004 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2014-08-15 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

Download or read book Handbook of Pharmaceutical Manufacturing Formulations Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-11-25 with total page 574 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Download or read book WHO Guidelines on Good Agricultural and Collection Practices GACP for Medicinal Plants written by World Health Organization and published by World Health Organization. This book was released on 2003-12-16 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicinal plant materials are supplied through collection from wild populations and cultivation. Under the overall context of quality assurance and control of herbal medicines WHO developed the Guidelines on good agricultural and collection practices (GACP) for medicinal plants providing general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines. These guidelines are also related to WHO's work on the protection of medicinal plants aiming promotion of sustainable use and cultivation of medicinal plants. The main objectives of these guidelines are to: (1) contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality safety and efficacy of finished herbal products; (2) guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and (3) encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general. These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations. Good agricultural and collection practices for medicinal plants are the first step in quality assurance on which the safety and efficacy of herbal medicinal products directly depend. These practices also play an important role in protection natural resources of medicinal plants for sustainable use.

Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by . This book was released on 2011 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This CD-ROM includes the entire set of current WHO guidelines relating to quality assurance. All guidelines included in this collection have been prepared in consultation with the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc., through a vast global consultative process. The draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards. This is a comprehensive updated edition of the compendium and it includes all current text most of which were published in the WHO Technical Report Series and in the Vol. 1 and 2 of the printed version of the Quality Assurance of Pharmaceutical Compendium. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.

Download or read book The ASQ Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2024-09-30 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.