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Past Free Issues
- Rx Distribution Licenses: A Matter of State
- U.S. FDA IDs Solutions to Drug Shortages
- Save Money by Attending TRI Courses
- Lack of Compendia Harmony for Visible Particles Causing Confusion
- Audit Program Part of FDA Pathway for Global Product Safety
- Progress of the Quality Topics at the ICH Meeting in Seville
- New Participation Opportunity: Nominate a BoD Candidate
- First PCMO TR Coming in March
- Interview with James Akers On Revised USP <1116>
- U.S. FDA Paves the Way for Biosimilars in US
May PDA Letter
Free Articles to All PDA Members and Non-Members.
Considerations for Successful Design, Operation and Maintenance of an Ultrapure Water System
Water is undoubtedly the most fundamental requirement in the pharmaceutical manufacturing environment, but it is often an overlooked commodity in terms of maintenance and assurance of low bioburden levels. While multiple preventive measures are implemented into most water purification systems, contamination of the water by microorganisms remains a cause for concern.
Water is undoubtedly the most fundamental requirement in the pharmaceutical manufacturing environment, but it is often an overlooked commodity in terms of maintenance and assurance of low bioburden levels. While multiple preventive measures are implemented into most water purification systems, contamination of the water by microorganisms remains a cause for concern.
Recent Fakes Prompt New Regulatory/Legislative Reactions
The U.S. FDA is pushing harder for the implementation of track and trace methods for drug products to protect patients from dangerous, low-quality fakes. Recent findings of counterfeit Avastin, a Roche anticancer drug, only heighten FDA’s concern over the growing threat to patient safety in the United States.
The U.S. FDA is pushing harder for the implementation of track and trace methods for drug products to protect patients from dangerous, low-quality fakes. Recent findings of counterfeit Avastin, a Roche anticancer drug, only heighten FDA’s concern over the growing threat to patient safety in the United States.
Task Force Corner: Technical Report on Bioburden and Biofilm in Pharma Processing Operations to be Published in 2012
The Bioburden and Biofilm Management Task Force has set a goal to publish a new PDA technical report to address the important problem of bioburden and biofilm management in pharmaceutical processes in 2012.
The Bioburden and Biofilm Management Task Force has set a goal to publish a new PDA technical report to address the important problem of bioburden and biofilm management in pharmaceutical processes in 2012.
Read the full May Issue (Member's Only)
Read about designing an ultrapure water system, biofilm myths and industry and regulators’ proposals to track drug products in the supply chain.
Read about designing an ultrapure water system, biofilm myths and industry and regulators’ proposals to track drug products in the supply chain.