Featured Pharma Online Editorial

71. Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations 4/21/2023

    Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.

72. Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems 4/20/2023

    While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

73. 4 Risk Mitigation Strategies For mRNA Production 4/17/2023

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

74. Strength Biowaivers For Immediate Release Oral Solid Drug Products: European & American Perspectives 4/13/2023

    A strength biowaiver is usually claimed for an additional strength when bioequivalence has been established for one strength and the biopharmaceutics classification system biowaiver is not applicable. Six factors need to be considered with additional strength biowaivers, and this article shares the regulatory requirements in the U.S. and Europe.

75. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

76. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

77. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

78. What Is Contributing To The API Shortage? 2/8/2023

    No, you can’t have your cake and eat it, too. In this case, your “cake” is a 6-cents-worth generic pill. We have seen a precarious competitive situation with generic drug manufacturing for several years now; what are the key trends and their impacts on the pharma supply chain? Let's investigate.

79. EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products 1/18/2023

    The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

80. ICH Final Q13 Guideline For Continuous Manufacturing: What It Means 12/16/2022

    The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.