Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
by Philip J. Hilts

List Price:   $26.95

Hardcover: 394 pages

Publisher: Knopf; (March 25, 2003)

ISBN: 037540466X

This popular book gives the history of the Food and Drug Administration and of the consumer legislation that led to the regulation of food and pharmaceutical quality.  It begins with the era of the Robber Barons where companies marketed patent medicines, snake oil, and adultered food without government interference.  It examines the impact of the Progressive movement as creating the initial push for government oversight and takes us to the current era where there is still a tension between business (especially nutrient supplements) and government.  JdK

Documentation Basics That Support Good Manufacturing Practices
Carol Desain

Hardcover: 88 pages

Publisher: Aster Pub Corp; (March 1993)

ISBN: 0943330300

Ron Midgett, the Director of Training of Lonza Pharmaceuticals who works with Sonia Wallman suggested this book.  JdK

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Science Series No 52)
Sidney H. Willig, James R. Stoker

Hardcover:

Publisher: Marcel Dekker; 3rd Revision edition (October 1991)

ASIN: 0824785940

Other Editions: Hardcover (4th) | All Editions

Regulatory Practice for Biopharmaceutical Production
Anthony S. Lubiniecki (Editor), Susan A. Vargo (Editor)

List Price:   $225.00

Hardcover: 566 pages

Publisher: John Wiley & Sons; 1 edition (July 13, 1994)

ISBN: 047104900X

BioGMP training software from SPI

This excellent software covers topics in Good Manufacturing Practices and offers a quiz at the end of each unit.  The author Antonio Moreira is a chemical engineer from the University of Maryland.  The $ 1,500 price is obviously for industry and not academics, but he offers a two-day seminar twice a year for $ 1,750 that includes the software in the price of the course. JdK

Online demo www.spi.pt/biogmp

Crab Wars: A Tale of Horseshoe Crabs, Bioterrorism, and Human Health
by William Sargent

List Price:   $24.95

Hardcover: 208 pages

Publisher: University Press of New England; 1st edition (November 2002)

ISBN: 1584651687

Sargent is a wildlife biologist who has been fascinated by horseshoe crabs his entire life.  This personal tale weaves the biology and wildlife management of these creatures into the story of how a few Woods Hole biologists discovered that a lysate of their amoebocyte cells could generate an assay for endotoxin; this assay was so sensitive that it became the industry standard and spawned an industry to supply it.  Sargent raises worries about the health of the Limulus population and argues that the importance of Limulus lysate can be used as an argument to maintain healthy stocks for a sustainable harvest.     JdK

Guidelines for Laboratory Quality Auditing
by Donald C. Singer, Ronald P. Upton

List Price:   $75.00

Hardcover: 411 pages

Publisher: Marcel Dekker; (January 1993)

ISBN: 0824787846 | All Editions

This is an all inclusive guide for a quality laboratory.  Appendices compare and contrast regulations from government agencies as well as contain sample documentation for control.