Pharmaceutical Dissolution Testing

Pharmaceutical Dissolution Testing
By Jennifer Dressman, Johannes Kramer

Description:

An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.

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Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical
By Guy Wingate

Description:

The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.

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Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
By Sarfaraz K. Niazi

Description:

Essentially a cookbook for making drugs, the six-volume handbook contains the recipes and process steps for over 2000 drugs, including a number of biotechnology drugs. The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications, and the BASF book of generic formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations. Each entry begins with a fully validated scaleable master manufacturing formula that includes the compendial specification requirement for each ingredient, process controls for manufacturing and release of the product, a summary of manufacturing process, and more.

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Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals

Description:

The second volume of the Compendium on quality assurance of pharmaceuticals has been updated to include all new and revised texts published by WHO through the end of 2003 in the area of good manufacturing practices (GMP), inspection and the use of risk analysis in production of pharmaceuticals. All together it includes 15 different guidance texts which were all adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The texts have been developed, revised and reviewed in a consultative process through participation of members of WHO expert panels, specialists, international professional associations , institutions, international organizations, NGOs and other third parties recognized as being competent in this field.

The texts cover good manufacturing practices and inspection of production sites and distribution channels, as well as the quality system requirements of national GMP inspectorates. The good manufacturing practices include main principles as well as supplementary texts for a number of specific types of products. There are in total six new guidance texts ; two guidelines have been updated.

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ISO 9000: Quality Systems Handbook

ISO 9000 Quality Systems Handbook (4th Edition)
By David Hoyle

Description:

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

ISO 9001: 2000 Quality Management System Design
By Jay Schlickman

Description:

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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USP NF 2007 (United States Pharmacopeia/National Formulary)

USP NF 2007 (United States Pharmacopeia/National Formulary)

Description:

The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopoeial Convention. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the U.S.A. and many other nations. Therefore, in case of a dispute, those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.

Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.

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

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer
By Sidney H. Willing

Description:

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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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
By Syed Imtiaz Haider


Description:

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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Indian Pharmacopoeia 1996

ISBN: 8190065831

Place of Publication: New Delhi

Publisher: The Controller of Publications

Edition: 1st ed.

Year of Publication: 2003

Physical Description: 140p.

Book Format: Hardcover

Language: English

Description:
The latest edition of the Indian Pharmacopoeia was published in 1996. It was updated by additions and amendments introduced through addendum 2000. Under the Drugs and Cosmetics Act, 1940, the Indian Pharmacopoeia is the legally recognised book of standards for the quality of drug substances and their preparations included therein. In view of the rapid developments is pharmaceutical sciences and technology, it became necessary to make further changes in the existing compendium. Addendum 2002 amends as well as adds new drugs and preparations to the Indian pharmacopoeia 1996 with a view to keeping the pharmacopoeia updated to the extent possible. Besides amending the existing monographs and appendices, it contains 19 new monographs including monographs of 12 antiretroviral drugs and 7 formulations of these substances. A new appendix on residual solvents has been incorporated. Some monographs have undergone major amendments. The appendix on high performance liquid chromatography has been replaced with a new version which also includes the ion chromatography. The Addendum 2002 is a companion volume to the Indian pharmacopoeia which is indispensable for all concerned with the quality of drugs.

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PART 1
PART 2
PART 3

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Serial: 1111-1111