ISPE and PDA Create Guide to Improving Quality Culture in Pharmaceutical Industry

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The Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) today announce the joint publication of a guide for Root Cause Analysis (RCA) to help the pharmaceutical industry improve quality culture by providing recommendations for tools, techniques, and processes.

The Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) today announce the joint publication of a guide for Root Cause Analysis (RCA) to help the pharmaceutical industry improve quality culture by providing recommendations for tools, techniques, and processes.

The organizations also announced today that they have signed a Memorandum of Understanding (MOU) confirming their plans to continue to advance practical approaches for quality culture. The first product of this collaboration is the RCA guide, which will assist the pharmaceutical industry in evolving and identifying best practices, tools and appropriate references for root cause analysis. The MOU leaves open the possibility that the organizations could directly collaborate on additional topics in the future.

The organizations selected RCA as the first topic in this undertaking as root cause analysis forms a significant part of any organization’s continuous improvement program. The lack of rigor applied to identifying the true root cause of failure events often leads to situations where the causal factors or effects of a given failure are identified and corrected, rather than the underlying cause. These symptoms of failure are often more visible and easily reported, while the actual root cause(s) of the problem may go unaddressed. This practical guide identifies a range of RCA tools along with recommendations for their application in the search for true root cause.

The RCA guide is available at ISPE’s website, http://www.ispe.org/ImproveCulture, and at PDA’s website, http://www.pda.org/ImproveCulture.

About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) it the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of over 10,500 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.

About ISPE - Connecting Pharmaceutical Knowledge
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.

For more information, contact:
Amy Henry
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1- 813-960-2105
Email: ahenry@ispe.org
http://www.ISPE.org

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Amy Henry
ISPE
+1- 813-960-2105
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