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.

DOWNLOAD FROM HERE

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.

DOWNLOAD FROM HERE

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.

DOWNLOAD FROM HERE

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.

DOWNLOAD FROM HERE

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.

DOWNLOAD FROM HERE