Author: Publisher:
ISBN: 9789241545044
Category : Drug and narcotic control
Languages : en
Pages : 0
Book Description
Quality Assurance of Pharmaceuticals
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9789241546195
Category : Business & Economics
Languages : en
Pages : 250
Book Description
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).
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9240086080
Category : Business & Economics
Languages : en
Pages : 1354
Book Description
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.
Quality Assurance Of Pharmaceuticals, Vol. 2, 1/Ed.
Author: World Health OrganizationPublisher:
ISBN: 9788174732859
Category :
Languages : en
Pages : 236
Book Description
Quality Assurance of Pharmaceuticals
Author: Quality Assurance of Pharmaceuticals
Author: World Health OrganizationPublisher:
ISBN: 9789241545266
Category : Drugs
Languages : en
Pages : 202
Book Description
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.
Quality assurance of pharmaceuticals
Author: Quality Assurance of Pharmaceuticals
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9241547081
Category : Business & Economics
Languages : en
Pages : 414
Book Description
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.
WHO Expert Committee on Specifications for Pharmaceutical Preparations
Author: WHO Expert Committee on Specifications for Pharmaceutical PreparationsPublisher: World Health Organization
ISBN: 9241209437
Category : Business & Economics
Languages : en
Pages : 173
Book Description
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.
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition
Author: Graham P. BunnPublisher: CRC Press
ISBN: 1498732070
Category : Medical
Languages : en
Pages : 371
Book Description
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.
Author: