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

ISBN-13: 9781439849941 / Angielski / Twarda / 2011 / 484 str.

Syed Imtiaz Haider; Erfan Asif Syed

Opis

A valuable tool for chemists and analysts working in Quality Control laboratories, this book provides technical solutions that fulfill training requirements and build skilled manpower. The text is written for practitioners in quality control laboratories, product development laboratories, and stability laboratories in pharmaceutical and bio-pharmaceutical manufacturing, along with students in pharmaceutical and biotechnology development. It includes chapters on various elements commonly used in quality control labs, with questions at the end to ensure understanding. It also includes training manuals, training log and a CD-ROM on various laboratory aspects.

Spis treści

Preface. Analytical Methods, Techniques and Quality Measures for General Pharmaceutical Products. Analytical Methods and Techniques for Biological Products. Laboratory Training Manual. Assessment of Training. Training Assessment with Quiz and Answers. Training Log. Analytical Method Validation Master Plan. Analytical Methods Validation Protocol. SOP for Annual Re-Qualification of HPLC Units. SOP for Annual Re-Qualification of GC Units. ABC Pharmaceutical Company. Regulations. Index.

O autorze

Syed Imtiaz Haider, Ph.D. is Quality Affairs Director at Gulf Pharmaceutical Industries (GPI) in the United Arab Emirates.