Tuesday, 9 July 2013

New book: risk assessment of pharmaceutical processing


A new book has been published titled “Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A contamination control perspective”. The book has been written by Tim Sandle.

The book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.

The core chapters are:

  • Risk management and risk assessment
  • Risk tool methods
  • Case study: environmental monitoring
  • Case study: aseptic processing
  • Case study: non-sterile product manufacturing
  • Case study: sterility testing isolator
The book balances regulatory guidance, theoretical concepts and practical examples.

The book is available from Amazon.

For Amazon U.S., go to Amazon US.

For Amazon U.K., go to Amazon UK

Posted by Tim Sandle