Pharmaceutical Science

Quality Assurance

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A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

Nuala Calnan, Martin J Lipa, Paige E. Kane, Jose C. Menezes
June 16, 2017

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also...

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance

Orlando Lopez
October 21, 2016

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based...

Good Design Practices for GMP Pharmaceutical Facilities, Second Edition

Terry Jacobs, Andrew A. Signore
June 27, 2016

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on...

Planar Chromatography - Mass Spectrometry

Teresa Kowalska, Mieczyslaw Sajewicz, Joseph Sherma
December 15, 2015

Planar Chromatography–Mass Spectrometry focuses on a relatively new approach to chemical analysis in general, and to separation science in particular. It is the first book to systemically cover the theoretical background, techniques, instrumentation, and practical applications of planar...

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Syed Imtiaz Haider, Erfan Syed Asif
June 06, 2012

To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for...

Dietary Supplement Good Manufacturing Practices: Preparing for Compliance

William J. Mead
November 17, 2011

Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations, outlining broad goals, intentionally avoid specifics to allow...

Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition

Steven W. Baertschi, Karen M. Alsante, Robert A. Reed
July 27, 2011

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The...

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

Syed Imtiaz Haider, Syed Erfan Asif
February 16, 2011

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...

Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition: Volume 2: Facility Design, Sterilization and Processing

Sandeep Nema, John D. Ludwig
August 26, 2010

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it...

Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition: Volume 1: Formulation and Packaging


August 26, 2010

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it...

Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality

Michael J. Akers
August 20, 2010

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions,...

Advanced Aseptic Processing Technology

James Agalloco, James Akers
July 23, 2010

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing...

Conferences

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