1st Edition
Good Pharmaceutical Manufacturing Practice Rationale and Compliance
By John Sharp
Copyright 2005
520 Pages
by
CRC Press
520 Pages
39 B/W Illustrations
by
CRC Press
520 Pages
by
CRC Press
Also available as eBook on:
With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance... Read more
Introduction - Status and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues. Personnel, Organization and Training. Premises/Buildings and Facilities. Contamination and Contamination Control. Equipment. Materials Control. Production and Process Controls. Packaging and Labeling Control. Holding and Distribution. Laboratory Controls. Records and Reports. Returned and Salvaged products. Sterile Products Manufacture. Other GMP Issues.
Biography
Sharp, John
