Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories

Offers guidance for the implementation of a quality management system in drug testing laboratories: a commitment to quality and continuous improvement.
The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.

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Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook, Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 2 - Regulations, Standards, and Guidelines)

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest.

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis)

Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

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Handbook of Water Treatment, 2nd English Edition

In the area of water treatment and process treatment chemicals, we have made technological improvements to ensure efficient operation and contribute to water and energy conservation in various water systems. We have also addressed critical issues surrounding water system treatment, such as the reduction of environmental impact through the development of non-phosphorus boiler compounds, non-hydrazine oxygen scavengers, and low- or non-phosphorus cooling water treatment chemicals. In addition, we have focused on the important task of ensuring work safety and chemical-handling safety. Our efforts have been rewarded with ISO 9001 and ISO 14001 certifications. We believe that these certifications are proof of our commitment to quality assurance for our products, and to environmental preservation and improvement. In order to introduce some of our company's innovative technology and accomplishments in the field of water treatment chemicals to a global readership, we published the first English edition of our handbook in 1985. Since then, we have continued working to develop more advanced technology and improved products. In this second edition, we have described our technologies and products in as much detail as possible, to ensure that we provide our readers with useful data.

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Validating Medical Packaging

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

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Water Properties of Food, Pharmaceutical, and Biological Materials

Unique and informative, Water Properties of Food, Pharmaceutical, and Biological Materials is based on lectures and papers given by leading international researchers at the 9^th

International Symposium of the Properties of Water in Foods (ISOPOW 9) that took place in September 2004. Each chapter presents an authoritative account of the latest research on the physical and chemical properties of water in relation to the stability of food, pharmaceutical, and biological materials.

The first part of the text focuses on presentations given by invited speakers, whereas the second part is dedicated to oral presentations and discussions. Topics include the role of water in structural and functional properties, preserving biomolecule functionality in restricted water environments, and micro- and nano- techniques used for assessing water-solid interactions in food and drug development.

This book is an invaluable resource that synthesizes cutting-edge information with innovativeviewpoints from internationally esteemed researchers who participated in ISOPOW 2004

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Environmental Monitoring for Cleanrooms and Controlled Environments

A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.

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A Primer on Quality in the Analytical Laboratory

Today's industrial laboratory analyst encounters issues such as quality control, quality assurance ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. In a well-written and readable style, A Primer on Quality in the Analytical Laboratory provides an introduction to quality, standards, and regulations in the analytical laboratory and serves as a valuable resource to a myriad of laboratory practices. Features.

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ISO 14001 - The World's EMS Standard [Vedio]

A Concise Introduction to the ISO 14001 Environmental Management System standard...ISO 14001 environment environmental management standard

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Quality Assurance in the Analytical Chemistry Laboratory

Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.

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ISO 14001 Environmental Certification Step by Step: Revised Edition

The do-it-yourself manual, with steps to success and simple explanatory notes, designed for real companies. ISO 14001 Environmental Certification Step by Step has been written with smaller companies especially in mind.

Dr. A.J. Edwards explains how to achieve the ISO 14001 standard aided by resources freely available from the accompanying website, including a sample manual and detailed sample registers and procedures. Together, these provide a quick and straightforward guide to achieving the requirements of ISO 14001 Environmental Certification.

This revised edition has been updated to cover the latest developments in the interpretation of the standard, plus changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), Control of Pollution regulations, Dangerous Substances and Explosive Atmospheres Regulations, Landfill charges, Pollution Prevention and Control, and Asbestos Regulations. In addition, the new ISO 19011:2002 standard for auditing is reflected in the book, as are approaches to phased introduction of ISO 14001.

Many organisations working towards ISO 14001 already possess ISO 9000 registration, or choose to achieve ISO 14001 and ISO 9000 simultaneously as an integrated system.To prevent duplication, ISO 14001 Environmental Certification Step by Step includes cross-referencing of ISO 14001 requirements to the relevant procedures in the Quality System.

* A do-it-yourself manual, with steps to success and simple explanatory notes
* Revised and updated to cover developments in the interpretation of the standard, changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), new standards and standards
* Supported by downloadable forms and procedures

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Environmental Management Plans Demystified: A Guide to ISO 14001

The drivers of consumer pressure and environmental awareness are forcing businesses to take a more critical view of their environmental management procedures. The development of an environmental management plan is an essential business activity that helps organize, direct and control operational activities, and plan for future environmental risk. Tinsley presents the process and procedures in a clear and accessible style, providing guidelines for plan creation and implementation. Examples of standard documentation, case studies, time tables, and checklists are included.

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Write It Down: Guidance for Preparing Documentation that Meets Regulatory Requirements

A well-understood tenet exists among the FDA and other regulatory bodies: if it isn't written down, it didn't happen! And if it didn't happen, companies stand to lose time, money, and perhaps their competitive edge. This book provides writers with the tools they need to put effective documentation in place. It offers a broad range of documents representative of the types of writing in the healthcare industry, from the laboratory to QA to manufacturing and regulatory affairs. The book offers valuable insights into managing systems and producing documentation that meets the requirements of both the FDA and ISO 9000.

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The Laboratory Quality Assurance System:A Manual of Quality Procedures and Forms

Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual:

-Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories.
-Provides blank forms used in preparing a quality manual.
-Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

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ISO 14001 Environmental Systems Handbook, Second Edition

ISO 14001 Environmental Systems Handbook Second Edition outlines the scope and purpose of the standard, making it accessible to all.

The author begins by explaining the concepts of the standard, which sets the tone for a practical guide to implementation of an ISO 14000-compliant environmental management system, which also covers the consultant's and auditor's perspective.

The case studies from industries that have actually undergone the process have been updated to include information on their progress toward environmental objectives in the 18-24 months following implementation. A new case study from a service organisation ( a car lease company) will be added. Finally there is input from training organisations and certification and accreditation bodies to assist with trouble-shooting and assessment. Additional information is also included on international legislative issues. Comparisons with ISO 9000 will also be fully updated to reflect revisions to this standard.

The book will offer the reader a range of options for implementation, and guidance on which is the best option to suit the particular organisation's culture.

* Fully updated to meet the new 2004 amendments to ISO 14001
* New case studies to show how ISO14001 is being implemented and is working for key organisations
* Proven track record of making understanding and implementing ISO14001 accessible

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Environmental management system ISO 14001

Environmental management system ISO 14001 -35 searching questions and contrasting pairs of examples The book is intended as a guide and work book for people taking part in a self evaluation process. The book describes the contents of the ISO 14001 standard using 35 questions and contrasting pairs of examples. The book can be used to help you understand the standard without any training. The book can be used to identify areas for development by comparing your own practices with those stipulated in the standard. The examples in the book help the self evaluation participants to understand what each of the questions means. For every question, an evaluation is made of its importance, as well as its current and target performance capability, on a scale of 1 - 5. The self assessment question form can be opened in the screen and filled out while reading the book. After filling in all the questions the result can be printed out. You do not need to be familiar with the ISO 14001 standard in order to answer the questions, just give your evaluation on the basis of your own imagination. The book’s job is to help you develop your imagination. The book, questions and self evaluation process can be adapted as a development tool and training material for the organisation even if the organisation does not adopt the ISO 14001 standard.

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ISO 9000 Quality Systems Handbook (4th Edition)

Completely revised to align with ISO 9000:2000, this handbook remains the most comprehensive book available on this series of international standards. ISO 9000 Quality Systems Handbook is an essential guide to enable organizations to understand and apply ISO 9001:2000 requirements and the principles that underpin this radical revision of the family of standards. Unlike other books on the subject, each element, clause and requirement is analysed in detail with practical guidance provided for its implementation. The handbook is written for those managing existing quality systems as well as those establishing a quality system for the first time. It is written in an easy-to-follow format and style suitable for students, practitioners, discerning managers, instructors and auditors. It offers a range of solutions that are acceptable in many industries. Based on the final draft of ISO 9001:2000, it details the differences from the 1994 version and includes check lists, questionnaires, tips for implementers, process flow charts and a glossary of terms. Comprehensive and practical guide Covers over 250 requirements of the standard Includes useful checklists, flow charts, related standards, bibliography.

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ISO 9001: 2000 Quality Management System Design

An effective ISO 9001:2000 quality management system, driven by a fully compliant quality manual, is key in meeting ISO 9000 quality standards and a must for obtaining ISO certification. Written by an RAB-certified quality management systems lead auditor, with 40 years of industrial experience - who has a 10-year track record in the consultation and auditing support of over 100 ISO-certified organizations-this book provides the design principles and techniques for implementing an effective quality management system.

The book describes the design rules required to document, implement and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands on guide is packed with tips and insights the author has garnered form personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user friendly, informative quality manual that together form the core of an effective and responsive quality management system.

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Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, 5th edition

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

This newly revised and expanded reference examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to interpret and comply with FDA Current Good Manufacturing Practice (CGMP) regulation and related criteria, and focusing on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers. Fifth Edition covers cross-licensing, joint ventures, strategic alliances, mergers, acquisitions, and divestitures that emphasize the necessity of maintaining quality control!

Adds descriptions of the Malcolm Baldrige National Quality Award and the ISO 9000 that drive customer satisfaction.

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