PDA Announces Open Access of Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages
TR-68 is the first ever proactive approach to avoid drug shortages at the product level
BETHESDA, Md., Feb. 18, 2015 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) today announced that it is releasing Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages (TR-68) to the public for free in an effort to reduce potential drug shortages caused by manufacturing quality issues. PDA has also made TR-68 available for all health authorities to post on their websites and will make electronic editable versions of the templates available to the industry. PDA will initiate training to enable quick industry adoption of the tools and templates.
TR-68 is the first ever structured, product-based approach for proactive identification and management of potential drug shortages caused by manufacturing quality issues. It outlines a risk-based approach for identifying issues that could lead to potential drug shortages. The Report provides practical guidance and tools for implementation of a proactive plan for avoiding drug shortages.
PDA also has made the document available on its webpage: http://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/drug-shortage
"It is our hope that all of industry will be able to immediately implement the methods, tools, and templates presented in the Technical Report to prevent these shortages," said PDA President Richard Johnson. "PDA is committed to continuing work on additional solutions for addressing drug shortages to achieve the goal of better serving patients."
About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is 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 its almost 10,000 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.
Media Inquiries: Walt Morris, 301-656-5900, x. 148; [email protected]
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SOURCE Parenteral Drug Association
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