CRC Press
Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
Key Metrics
- John Sharp
- CRC Press
- Paperback
- 9780367393779
- 9.9 X 7 X 1.1 inches
- 1.27 pounds
- Medical > Health Care Delivery
- English
Secure TransactionBook Description
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.
This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.
Author Bio
John Sharp was appointed Chancellor of The Texas A&M University System by the Board of Regents on Sept. 6, 2011.
Chancellor Sharp leads one of the largest systems in the country with an annual budget of $9.6 billion and an enrollment of more than 153,000 at the A&M System’s 11 universities. Additionally, under the System umbrella, there are eight state agencies.
Chancellor Sharp brings with him more than three decades of public service. He earned a bachelor’s degree in political science from Texas A&M University in 1972, where he was a member of the Corps staff of the Corps of Cadets, a member of the 1972 rugby team and was elected student body president. Upon graduation, Sharp was commissioned as a second lieutenant in the United States Army Reserve.
In 1976, Sharp received a master’s degree in public administration from Southwest Texas State University while working full-time with the Legislative Budget Board in Austin. In 1978, he opened a one-man real estate firm in Victoria and became a successful small business owner. That same year he was elected to the Texas House of Representatives.
In 1982, he won a seat in the Texas Senate, and four years later, he was elected to the Texas Railroad Commission. He also was elected state comptroller in 1990 and re-elected in 1994.
Source: The Texas A&M University System
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