Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management.

• Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues

• Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements

• Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries

• Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization

• Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate

The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance. 

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Good Laboratory Practice Regulations Vol 69

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation.

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Good Laboratory Practice: OECD Principles And Guidelines for Compliance Monitoring

This publication unites all of the OECD documents related to Good Laboratory Practice and compliance monitoring, and, in the Annex, reproduces the three OECD Council Decisions related to the Mutual Acceptance of Data in the Assessment of Chemicals. It includes the international standards for quality of non-clinical environmental, health and safety data on chemicals and chemical products in a regulatory context—the OECD Principles of Good Laboratory Practice—and supporting Consensus and Advisory Documents on their interpretation and application. The OECD guidance documents for governments on monitoring compliance with the Good Laboratory Practice Principles are also included. This publication thus presents the state of the art on Good Laboratory Practice and compliance monitoring.

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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

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A Practical Guide to Quality Management in Clinical Trial Research

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

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ORA Quality Manual, January 2007

The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) Quality Management System (QMS). The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and FDA who wish to understand the ORA QMS. Use of this manual presumes some understanding of quality system principles and standards.

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http://rapidshare.com/files/97417420/Qty.manual07.zip

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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http://rapidshare.com/files/90110386/Pri_quy_ana_lab.zip

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals.

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http://rapidshare.com/files/87782640/FDA_Regu_aff.zip

CRC Handbook of Laboratory Safety, Fifth Edition

Expanded and updated, The CRC Handbook of Laboratory Safety, Fifth Edition provides information on planning and building a facility, developing an organization infrastructure, planning for emergencies and contingencies, choosing the correct equipment, developing operational plans, and meeting regulatory requirements. Still the essential reference tool, the New Edition helps you organize your safety efforts to adhere to the latest regulations and use the newest technology. Thoroughly revised, the CRC Handbook of Laboratory Safety, Fifth Edition includes new OSHA laboratory safety standards, the 1994 NRC radiation safety standards, guidelines for X-ray use in hospitals, enforcement of standards for dealing with blood-borne pathogens, OSHA actions covering hazardous waste operations and emergency response, and the latest CDC guidelines for research with microbial hazards. Every word on every page has been scrutinized, and literally hundreds of changes have been made to bring the material up to date. See what's new in the New Edition o New figures and tables illustrating the new material o Internet references in addition to journal articles o Changes in the Clean Air Act regarding incineration of hospital, medical, and infectious waste o Obsolete articles removed and replaced - over one hundred pages of new material o New information on respiratory protection guidelines.

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http://rapidshare.com/files/85879660/Lab_Safety_5ed.zip

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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http://rapidshare.com/files/79113633/QA_Ana_Chem_Lab.zip

Managing the Analytical Laboratory: Plain and Simple

A clear, concise manual on how to run a quality control testing laboratory efficiently and in compliance with all regulations, this book provides hundreds of tips and techniques that help the reader focus on the essential elements of good laboratory management. It presents thirty-nine useful SOPs that have evolved from the author's years of practical experience. Fifteen case studies describe typical laboratory problems and offer possible solutions. From how to train analysts, to how to lay out the laboratory, to how to assure that samples are processed in a systematic manner, Managing the Analytical Laboratory: Plain and Simple covers it all.

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http://rapidshare.com/files/74382839/Managing_Ana_Lab.zip

Validation and Qualification in Analytical Laboratories, Second Edition

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

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http://rapidshare.com/files/67987349/Vali_Quali_Anal_Lab.zip

Good Laboratory Practice Regulations, Fourth Edition

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

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http://rapidshare.com/files/47846820/GLP_Regulations_4th.zip

Applied Thin-Layer Chromatography: Best Practice and Avoidance of Mistakes

Thin layer chromatography (TLC) is a powerful, fast and inexpensive analytical method. It has proven its usefulness in pharmaceutical, food and environmental analysis. This new edition features a completely revised chapter on documentation, now including the use of digital cameras. Selected new sorbents and instruments are also introduced.

Why has the prior edition been successful? All steps of the analytical procedure are clearly explained, starting with the choice of a suitable TLC technique and ending with data evaluation and documentation. Special emphasis is put on the proper choice of materials for TLC. Properties and functions of various materials and the TLC equipment are described, covering e. g. precoated layers, solvents and developing chambers, and including information on suppliers. Many practical hints for trouble shooting are given. All this is illustrated with numerous coloured figures.

How to use TLC in compliance with GLP/GMP regulations is described in detail, including the required documentation. Therefore the reader can very easily compile his own standard operating procedures.

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http://rapidshare.com/files/43933108/Applied_Thin-Layer_Chromatography.zip

Good Laboratory Practice: the Why and the How

The second edition of this concise hands-on guide to implementing Good Laboratory Practice standards has been fully updated to include the latest changes in the regulatory framework. Particularly the areas of in vitro testing and multi-site studies have undergone considerable developments in recent years.

This practice-oriented guide introduces the reader to the background, basic principles, operating procedures and OECD standards. It gives invaluable information on how to avoid pitfalls and save precious time and resources. It will be an essential acquisition for anyone concerned with modern GLP.

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http://rapidshare.com/files/43374402/GLP_why_how.zip

GLP Quality Audit Manual, Third Edition

Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section Ill comprises the full texts of the relevant standards and regulations along with the Priniciples of Good Laboratory Practice.

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http://rapidshare.com/files/43371092/GLPAQAM3.zip

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required.
This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States.

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