Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection PDF Download

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547081
Category : Business & Economics
Languages : en
Pages : 414

View

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.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240086080
Category : Business & Economics
Languages : en
Pages : 1354

View

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.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240099425
Category : Business & Economics
Languages : en
Pages : 1788

View

Book Description
This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.

Author: Brendan F. Gilmore
Publisher: John Wiley & Sons
ISBN: 1119434556
Category : Medical
Languages : en
Pages : 580

View

Book Description
Hugo & Russell’s Pharmaceutical Microbiology Discover the very latest developments in pharmaceutical microbiology in the 9th edition of this popular textbook Microbiology is one of the essential pharmaceutical sciences upon which the study and practice of pharmacy is built. It has a bearing on all aspects of the manufacture of medicines and sterile products, from their design and development to their delivery as quality products. Few interventions are more central to modern medicine than the treatment of infection, where antibiosis, vaccination and hygienic practices have essential roles to play. The COVID-19 pandemic, the appearance of new pathogens and the rise of antibiotic resistance have demonstrated most completely the need for pharmaceutical practitioners, researchers and industrial scientists to be fully conversant with this field. The 9th edition of Hugo and Russell’s Pharmaceutical Microbiology has been updated to meet this need. Having long served as the sole comprehensive textbook covering this subject, it has now been adapted to a critical new period in the advancement of medical and pharmaceutical research and development. Its experienced editors have incorporated contributions from subject experts and created a text which will serve the next generation of pharmacy students, pharmaceutical industry scientists and researchers. In this ninth edition of Hugo and Russell’s Pharmaceutical Microbiology, readers will find: A mix of established and new authors bringing practical and research experience to their chapters Material covering the fundamentals of microbiology, microbial behavior and laboratory investigation Revised chapters incorporating new material on microbe-host interactions, antibiotic resistance, emerging pathogens, public health microbiology, healthcare-associated infection and pharmaceutical manufacture Emerging understandings from the COVID-19 pandemic on infection prevention and control and vaccine development Practitioners providing their insights on clinical practice and pharmaceutical production An accompanying website incorporating teaching resources Hugo and Russell’s Pharmaceutical Microbiology, 9th edition promises to remain the essential text for pharmacy and medical students, as well as researchers and industry professionals.

Author: R. Baird
Publisher: CRC Press
ISBN: 1135743630
Category : Science
Languages : en
Pages : 272

View

Book Description
The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.

Author: B.P. Nagori
Publisher: Scientific Publishers
ISBN: 938774101X
Category : Medical
Languages : en
Pages : 280

View

Book Description
he present state-of-art book has been written as per the new syllabus of B. Pharmacy, introduced by Pharmacy Council of India (PCI). This book has an inclusive content that covers the wider aspects of pharmaceutical quality assurance required by under- graduates, post graduates, industry personnels, researcher, and students preparing for various competitive exams. The distinguishing feature of this book is that the book is written in lucid, simple and easy to understand language. The book is accompanied with Multiple Choice, Fill in the Blank, True-False, Short Answer and Long Answer type of questions for the self- evluation of learning. The answers of the Multiple Choice, Fill in the Blank and True-False questions have also been given. Web links/further reading are included to help the readers for keeping themselves abreast with th latest developments in the held of pharmaceutical quality assurance. Academicians and instructors in universities/colleges may use the book as primary or additional teaching material for under-graduate and post-graduate pharmacy courses.

Author: WHO Expert Committee on Specifications for Pharmaceutical Preparations
Publisher: World Health Organization
ISBN: 9241209437
Category : Business & Economics
Languages : en
Pages : 173

View

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.

Author: C.J. van Boxtel
Publisher: IOS Press
ISBN: 160750345X
Category : Medical
Languages : en
Pages : 846

View

Book Description
This updated and revised 2nd edition of Drug Benefits and Risks is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs, but in this context also highlighting the social impact which drugs have in modern societies. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases; the book gives guidance on how doctors should act so that drugs can be used effectively and safely; and it encourages the rational use of drugs in society. This publication brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.

Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 0873899334
Category : Business & Economics
Languages : en
Pages : 386

View

Book Description
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: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594

View

Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks