Two Books for GxP Professionals

GxP Perspectives Reads Up on Compliance and Bacteria

There are two recent books of interest to GxP professionals. It has been a while since this blog has reviewed a book, but there will be more in the near future including a new review by Sid Olufs on Organizational Image and Pharmaceutical Regulation at the FDA, by Daniel Carpenter that was discussed in a recent post: Can This Agency be Dangerous? John Avellanet, a compliance consultant and author of Compliance Zen on the blogroll, and Anne Maczulak, a microbiologist and past board member of the Pacific Regional Chapter of the Society for Quality Assurance, have both published books that GxP Perspectives would like to let you know about. If you know about other books relevant to our industry, please let me know.

John Avellanet, a compliance professional, stresses the importance of regulatory compliance in Get To Market Now! Turn FDA Compliance into a Competitive Edge. I really don’t like the title, a bit too commercial for me, but John is knowledgeable about the topic and his publisher probably had something to do with the title. The book actually covers today’s regulatory landscape and the importance of quality systems in gaining market approval. He points out that data integrity is of paramount importance to regulators and cites an FDA official’s statement that one third of drug pre-approval inspections are initiated because of data integrity concerns. We can also look to recent warning letters to sponsors of clinical trials- the top concern was falsification of data.

Develop Quality
From Day One

Quality by Design: Avellanet stresses quality by design. He gives the background of quality by design and discusses the concept from the FDA perspective of Pharmaceutical cGMPs in the 21st Century: A Risk-Based Approach (2002). However, Avellanet advocates that quality by design is not just for GMPs but for the entire life cycle of the development process. His book reviews step-by-step how to incorporate quality into the product development and post-marketing compliance standards. He frequently cites FDA sources from documents and professional conferences to tie FDA positions to industry quality standards. The publisher states:

“At the heart of the book, a systemic, structured new medicinal product development process – from discovery and preclinical through the postmarket stages – and a regulatory compliance and quality system designed to enhance business flexibility and encourage innovation.”

For additional information see the Get2Market website.

John’s Blog: Compliance Zen

Anne Maczulak is a microbiologist and consultant with Acorn GLP Consulting. She is also a past officer of the Pacific Regional Chapter of SQA. I am currently serving on the board (until the end of the year) so I’m always happy to let the blogosphere know about the Pacific Coast’s GxP professional experience. Here is an editorial review of her book, Allies and Enemies: How the World Depends on Bacteria [Hardcover].

Bacteria: How they keep you alive. How they can kill you. How we can all live together happily.

Allies & Enemies: Exploring the World of Bacteria

Bacteria are invisible, mysterious, deadly, self-sufficient…and absolutely essential for all life, including yours. No other living things combine their elegant simplicity with their incredibly complex role: Bacteria keep us alive, supply our food, and regulate our biosphere. We can’t live a day without them, and no chemical, antibiotic, or irradiation has ever successfully eradicated them. They’re our partners, like it or not–even though some of them will happily kill us.

Coming Soon:
A Guest Commentary on Bacteria and GxPs

Allies and Enemies tells the story of this amazing, intimate partnership. Authored by Anne Maczulak, a microbiologist who’s hunted and worked with an extraordinary array of bacteria, this book offers a powerful new perspective on Earth’s oldest creatures. You’ll discover how bacteria work, how they evolve, their surprising contributions and uses, the roles they’ve played in human history, and why you can’t survive without them. No form of life is more important, and in Maczulak’s hands, none is more fascinating.

Check it out: Allies and Enemies

Anne’s Website: Acorn GLP

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In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA.

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Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.

And we have our Book Reviews by Sid page as well. Everything you need for the GxP Professional.