The Certified Pharmaceutical GMP Professional Handbook, Second Edition
The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Author: Mark Allen Durivage

Publisher: Quality Press

Published: 2016-05-26

Total Pages: 386

ISBN-13: 0873899334

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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.

Water Safety Plan Manual
Water Safety Plan Manual

Author: World Health Organization

Publisher: World Health Organization

Published: 2009

Total Pages: 109

ISBN-13: 9241562633

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In 2004, the WHO Guidelines for Drinking Water Quality recommended that water suppliers develop and implement "Water Safety Plans" (WSPs) in order to systematically assess and manage risks. Since this time, governments and regulators, water suppliers and practitioners have increasingly embraced this approach, but they have also requested further guidance. This much-anticipated workbook answers this call by describing how to develop and implement a WSP in clear and practical terms. Stepwise advice is provided through 11 learning modules, each representing a key step in the WSP development and implementation process: 1. Assemble the WSP team; 2. Describe the water supply system; 3. Identify hazards and hazardous events and assess the risks; 4. Determine and validate control measures, reassess and prioritise the risks; 5. Develop, implement and maintain an improvement/upgrade plan; 6. Define monitoring of the control measures; 7. Verify the effectiveness of the WSP; 8. Prepare management procedures; 9. Develop supporting programmes; 10. Plan and carry out periodic review of the WSP; 11. Revise the WSP following an incident ; Every Module is divided into three sections: 'Overview', 'Examples and Tools', and 'Case studies'. The overview section provides a brief introduction to the Module, including why it is important and how it fits into the overall WSP development and implementation process. It outlines key activities that should be carried out, lists typical challenges that may be encountered, and summarizes the essential outputs to be produced. The examples and tools section provides resources which could be adapted to support the development and implementation of WSPs. These resources include example tables and checklists, template forms, diagrams, or practical tips to help a WSP team address specific challenges. These are often example outputs and methodologies adapted from recent WSP experiences. Each Module concludes with case studies so the reader can benefit from lessons-learned from real-life experiences. They are intended to make WSP concepts more concrete and to help readers anticipate issues and challenges that may arise. The descriptions were drawn from WSP initiatives in Australia, the Latin American and the Caribbean region (LAC), and the United Kingdom.