This revised and expanded new edition covers 33 elements that would be found in a modern, comprehensive pharmaceutical quality system. Each chapter includes an overview of the quality element and suggested risk-related questions. Three to ten expectations provide details along with relevant citations from the US CGMP regulations and the Canadian and European GMPs. World Health Organization (WHO) and International Conference of Harmonization (ICH Q8, Q9, and Q10) references are also provided.
GMP in Practice is published by PDA and Davis Healthcare International Publishing. Use the coupon code GMP4 to receive a 10% discount. (One discount per order.)