The Certified Pharmaceutical GMP Professional Handbook

The Certified Pharmaceutical GMP Professional Handbook
Author: Mark Allen Durivage
Publisher: Quality Press
Total Pages: 404
Release: 2016-05-23
Genre: Technology & Engineering
ISBN: 1951058909

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.

Good Clinical, Laboratory and Manufacturing Practices

Good Clinical, Laboratory and Manufacturing Practices
Author: Philip Carson
Publisher: Royal Society of Chemistry
Total Pages: 657
Release: 2007-10-31
Genre: Science
ISBN: 1847557724

Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals
Author: Dipak Kumar Sarker
Publisher: John Wiley & Sons
Total Pages: 204
Release: 2008-07-31
Genre: Science
ISBN: 0470773049

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

Practical Pharmaceutics

Practical Pharmaceutics
Author: Yvonne Bouwman-Boer
Publisher: Springer
Total Pages: 873
Release: 2015-08-24
Genre: Medical
ISBN: 3319158147

This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.

Environmental Law in Arab States

Environmental Law in Arab States
Author: Damilola S. Olawuyi
Publisher: Oxford University Press
Total Pages: 304
Release: 2022-02-11
Genre: Law
ISBN: 0192649914

Environmental Law in Arab States offers a comprehensive and authoritative account of the guiding principles and rules relating to environmental protection in the Arab region. Taking an international and comparative approach, the book introduces readers to the latest developments of environmental law across the Arab region through applicable legislation, green finance, and climate technologies The impact of these is assessed in each of the major areas of environmental regulation, air pollution, water pollution, biodiversity, conservation of nature and cultural heritage, infrastructure development, and Islamic ecology. Consideration is given to participatory and bottom-up legal strategies – focusing on transparency, accountability, gender justice, and other human rights safeguards – that are needed to achieve greater coherence and coordination in the implementation and enforcement of environmental regulation across the region. The book closes by providing legal assessments and reflections on how Arab countries can, through clear and comprehensive legislation, advance existing national strategies and visions on trade and investment, green growth, Islamic green finance, circular economy, blue economy, and low carbon future amongst others.

Good Clinical, Laboratory and Manufacturing Practices

Good Clinical, Laboratory and Manufacturing Practices
Author: Phillip A. Carson
Publisher: Royal Society of Chemistry
Total Pages: 657
Release: 2007
Genre: Science
ISBN: 0854048340

Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.

SEC Docket

SEC Docket
Author: United States. Securities and Exchange Commission
Publisher:
Total Pages: 1618
Release: 1988
Genre: Securities
ISBN:

ISO 9001:2015 for Small Businesses

ISO 9001:2015 for Small Businesses
Author: Ray Tricker
Publisher: Routledge
Total Pages: 633
Release: 2016-10-04
Genre: Business & Economics
ISBN: 1317685679

Small businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards. ISO 9001:2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. This edition includes: down-to-earth explanations to help you determine what you need to enable you to work in compliance with and/or achieve certification to ISO 9001:2015; a contextual explanation of ISO 9001 within the structure of ISO 9000 family of standards; a detailed description of the structure of ISO 9001:2015 and its compliance with Annex SL; coverage of the new requirements for Risk Management and Risk Analysis; a guide to the costs involved in implementing ISO 9001:2015 and advice on how to control costs; an example of a complete, generic Quality Management System consisting of a Quality Manual plus a whole host of Quality Processes, Quality Procedures and Word Instructions; and access to a free, software copy of these generic QMS files to give you a starting point from which to develop your own documentation. This book is also supported with a complete bibliography containing abbreviations and acronyms as well as a glossary of terms. This comprehensive text will provide you and your small business with a complete guide on your way to ISO compliance.

The ASQ Certified Pharmaceutical GMP Professional Handbook

The ASQ Certified Pharmaceutical GMP Professional Handbook
Author: Mark Allen Durivage
Publisher: Quality Press
Total Pages: 421
Release: 2024-09-30
Genre: Technology & Engineering
ISBN: 1636941516

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.