Latest Articles

  • A Commentary - The Strengths and Weaknesses of Industry Guidance Documents

    Evidence-based decision making in medicine, education, law enforcement, economics, public policy, etc. have frequently shown that current practices may be plain wrong, not cost effective, or even damaging to the public good. read more

  • Aligning Environmental Monitoring Expectations with Scientific Realities

    Considering the advances in aseptic processing and their effectiveness in eliminating the primary sources of contamination (i.e., human activity), it is not our intent to entirely disparage the value of monitoring. Environmental monitoring has some value in trend analysis within an overall contamination control strategy. However, it is not a control mechanism. read more

  • Typical and Representative, Part 1

    As technology in endotoxins and pyrogens testing changes, and as the basic research advances our understanding of pyrogenicity, fifty-year-old assumptions and decisions should be revisited, if not challenged. Given that it is neither typical nor representative of potential contaminants, is the current calibrant still an appropriate analyte for endotoxins and pyrogens testing? read more

  • Pharmaceutical P.I.N. Points: Patent Innovation News

    The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in June-July, 2026. read more

  • Featured Documentary: A Solid Dosage Future

    While biopharmaceuticals continue to grab much of the limelight in the pharmaceutical industry, the fact is solid dosage products (tablets, capsules, pills, etc.) still account for the majority of medicinal products made worldwide. The reasons for this market share are abundantly clear: patients are familiar with the dosage form and are comfortable using it. In addition, the industry has many decades of experience designing, formulating, testing, manufacturing and packaging solid dosage products. The knowledge base is extensive. read more

  • Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products

    Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and error in the Clean Facility of the Future Documentary. read more