Just Released: Risk-Based Approach for Prevention and Management of Drug Shortages Technical Report 24 June, 2024

For 78 years, PDA has supported our members and the pharmaceutical industry in their work to provide patients with the medicines they need. Unfortunately, drug shortages have become more frequent, more severe, and longer-lasting globally, and the causes are, in most cases multifactorial. Based on the impact this issue has to the pharmaceutical companies and the patients they supply; PDA has made the decision to provide the recently released impactful Technical Report No. 68 free of charge globally.

PDA believes that Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages is applicable to every aspect of the pharmaceutical industry. As such PDA is taking the step to ensure that all members of the industry benefit from the framework, strategies and tactics included in the report.

TR-68 provides a practical framework that companies can leverage, a triage model to assess drug shortage risks, and templates for developing a Drug Shortage Risk Register and Drug Shortage Prevention and Response Plan at a product level.

"Ensuring an uninterrupted supply of safe, high-quality, efficacious products to patients is, without question, the first and overriding goal of our industry, and PDA is gratified to continue partnering with and supporting our members and the industry in achieving this goal," said Glenn E. Wright, PDA's President and CEO.

To access the free report click here. You will be required to create an account on PDA's website before receiving the downloadable report and its appendices.

PDA routinely publishes Technical Reports for industry consumption and learning on a variety of topics including:

  • Risk Management: PDA has over 100 publications from books to technical reports on the many aspects of Risk Management.
  • Aseptic Processing: As one of the main pillars or pharmaceutical manufacturing, PDA has excelled at providing resources on Aseptic Processing including books, technical reports and points to consider, training courses, and conferences.
  • Process Validation: Over the years, PDA volunteers have contributed an incredible volume of information and guidance on Process Validation, which enables our members to effectively apply those concepts to ensure manufacturing practices are in a state of control.

About PDA Technical Reports

PDA Technical Reports are global consensus documents, prepared by member-driven volunteer teams of subject matter experts working in the pharmaceutical/biopharmaceutical industry, regulatory authorities, and academia. The level of expertise of the authoring team and those participating in the global review prior to publication ensure a broad perspective reflecting the best thinking and practices currently available.


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