PDA Letter Article

Second Book in PDA – Euromed Communications Series Now Available

by PDA

Industrial Pharmaceutical Microbiology: Quality Control is an in-depth, comprehensive survey of quality control methods in the pharmaceutical microbiology laboratory to enable better understanding and to ensure better developed, more compliant, expedited procedures. The reference text brings together the hitherto unavailable background, fundamental science, principles, development, intended purpose, and specific answers to questions of execution and qualification of compendial and related microbiological test methods. Key topics include the types of microbiological tests, reference strains and culture collections, and equivalence of reference strain.

Jeanne Moldenhauer, consultant and author, says the following about the new book:

Industrial Pharmaceutical Microbiology: Quality Control provides a wealth of information on pharmaceutical microbiology. The individual chapters are written by a majority, if not all, individuals who have served on USP committees or expert panels.

“One of the unique things about this book is that it provides a strong foundation for how the various compendial tests were developed, when they became incorporated into USP, and how they have changed over time. This historical perspective has not been easy to find in the past, without going through each year’s version of USP.

“Additionally, it provides the rationale for the various parameters and features of the compendial test methods. This information can be invaluable in trying to resolve difficulties in the test method and/or the conduct of investigations relative to the test method.

“This book is a must have for microbiologists and quality control personnel with responsibility over the microbiology laboratories.”

Industrial Pharmaceutical Microbiology: Quality Control is now available in the PDA Bookstore. This 500-page book includes 20 chapters from 19 industry leaders in pharmaceutical microbiology quality control. Electronic copies are sold at both publishers' bookstores for $299.00. Hardcopies can be purchased for $340 at Euromed Communication's website.

"This book should become a staple reference for the PDA membership, as pharmaceutical microbiology quality control is a topic central to the challenges faced by many working in our community," said Walter Morris, Senior Director of Publications and Press Relations, PDA. "Edward and Radhakrishna have done an excellent job assembling well-known authors who are frequent participants in other PDA activities."