Pharmaceutical Science

Quality Assurance

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Polysaccharide based Nano-Biocarrier in Drug Delivery

1st Edition

Tapan Kumar Giri, Bijaya Ghosh
September 21, 2018

This book discusses various fundamental aspects of polysaccharide based nano-biocarrier drug delivery systems and its application in the delivery of small molecules, proteins, peptides, oligonucleotides and genes. It also discusses advances in drug delivery systems in treatment of cancer,...

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

1st Edition

Orlando Lopez
September 19, 2018

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance...

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

1st Edition

Syed Imtiaz Haider, Syed Erfan Asif
July 31, 2018

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...

Quality Assurance and Quality Control in the Analytical Chemical Laboratory: A Practical Approach, Second Edition

2nd Edition

Piotr Konieczka, Jacek Namiesnik
April 30, 2018

The second edition defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Clearly written and logically organized, it takes a generic approach applicable to any field of analysis. The authors begin with the theory behind quality...

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

1st Edition

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

1st Edition

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

2nd 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

1st Edition

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

1st Edition

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

1st Edition

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

2nd 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...

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

3rd Edition

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...

Conferences

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