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, 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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Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:

• Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.
• Post-approval considerations and regulatory filing strategies to support a global supply chain.
• Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.
• Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.
• Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).
• USP-NF testing in support of stability.
• Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.
• Discussion of matrixing and bracketing to support reduced stability testing.
• Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

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cGMP: Generators, Effectors and Therapeutic Implications

cGMP: Generators, Effectors and Therapeutic Implications

After the discovery of endogenous NO formation in the late '80s and the 1998 Nobel Prize in Physiology or Medicine, many researchers and physicians again became interested in the NO/sGC interaction and cGMP-dependent signaling. This book is an enthusiastic celebration of cyclic guanosine monophosphate (cGMP) and amply illustrates the importance of this field of science to patients and the way in which the field has evolved. It is exclusively devoted to this exciting and important signaling molecule, addressing all recent advances in understanding guanylate cyclase regulation, NO/sGC interactions, cGMP effector mechanisms and their pathophysiological and pharmacological implications. Particular attention will also be given to clinical applications of the novel cGMP-elevating drugs which are on the horizon, thus spanning the continuum from basic science to clinic.

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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

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User Friendly Guide to Multivariate Calibration and Classification

User Friendly Guide to Multivariate Calibration and Classification

The field of chemometrics in general and multivariate calibration and classification in particular is now an essential tool for many analytical techniques. This book provides a readable text, for non-mathematicians, as a introduction to these areas for people with little or moderate knowledge of chemometrics. The book has been designed in an atractive and easily read format, with many diagrams and the use of margin notes to highlight important features.

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http://rapidshare.com/files/76715045/Uf_Multivariate_Calibration.zip

Instrumentation and Control Systems Documentation

Instrumentation and Control Systems Documentation

This book provides the reader with knowledge needed to understand and apply the symbols and documents used to define a modern industrial instrumentation and control system. The documents that describe modern industrial processes, like most technical work, assume some level of understanding on the reader’s part. The documents use aschematic, symbol-based “language” that may resemble Mayan hieroglyphics to those unfamiliar with the process nomenclature. The symbols, however, include a wealth of information once you are able to translate them.

This book will train you to read, understand, and apply the symbols and documents used to define a modern industrial instrumentation and control system. For more experienced professionals, insights into using the symbols and documents more effectively are provided. Variations in the use of symbols and documents are given as well as the pitfalls to avoid.

To better understand process documentation today, insight into how and when documents are developed, who develops them, why they are developed, and how they are used is provided. The types of documents discussed include process flow diagrams, piping and instrumentation drawings, instrument lists, specification forms, logic diagrams, installation details, location plans, and loop diagrams.

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http://rapidshare.com/files/89013595/Inst_Con_Sys_Doc.zip

Calibration in the Pharmaceutical Laboratory

Calibration in the Pharmaceutical Laboratory

Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable toolwhen setting out SOPs for balances and scales used throughout the manufacturing and testing process.

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Validation in Chemical Measurement

Validation in Chemical Measurement

The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.

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Encyclopedia of Controlled Drug Delivery, 2 Volume Set

Encyclopedia of Controlled Drug Delivery, 2 Volume Set

Covers all aspects of controlled drug delivery, including human, agricultural and animal applications. The 70 entries, written by an international team of renowned experts, offers A-to-Z coverage of controlled drug delivery systems for researchers in the pharmaceutical and biotechnology industries, agriculture companies, medical device companies, clinical research organizations and medical schools.

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Biopharmaceutics Applications in Drug Development

Biopharmaceutics Applications in Drug Development

In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics.

Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.

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http://rapidshare.com/files/119954013/Bioprma_app_DD.zip