Quality Assurance Of Pharmaceuticals A Compendium Of Guidelines And Related Materials Tenth Edition Volume 1 Good Practices And Related Regulatory Guidance
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Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance
Author: World Health Organization
language: en
Publisher: World Health Organization
Release Date: 2024-10-24
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.
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection
Author: World Health Organization
language: en
Publisher: World Health Organization
Release Date: 2024-01-31
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.
GMP Audits in Pharmaceutical and Biotechnology Industries
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment Covers a global regulatory landscape Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology