• How to Ensure Your Quality Culture Assures Data Integrity

    One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

  • Tools And Best Practices For Trending Environmental Monitoring Data

    Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.

  • Biopharma Cold Chain Logistics 101

    Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.

  • Why Adjusted Risk Likelihood Should Displace The Risk Priority Number

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

  • An Introduction To Trending In Environmental Monitoring Programs

    Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

  • FDA Inspections: Are Changes On The Horizon?

    A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

  • Life Sciences Deal-Making Gets Creative, Aims At Early Stages Amid COVID-19

    Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets. Check out this article highlighting takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook

  • Complying With Batch Release: Auditing Electronic Batch Records

    This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. 


  • Identifying Enhanced Needle Solutions & Integrated System Solutions To Serve The Chronic Disease Market

    In addition to wider uptake of home care, an increase in the number of biologics being manufactured, many by the same company, is driving ongoing innovation in drug delivery systems. Identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.

  • Adoption Of Controlled Ice Nucleation Technology, ControLyo® - From R&D To Commercial Manufacturing

    Stabilization by lyophilization is attractive to retain a drug product’s potency, structural integrity and homogeneity, all of which are crucial to the success of a pharmaceutical product. Lyophilization begins by lowering the temperature of the product to below its freezing point to form ice crystals (nucleation). However, this process is random and often results in heterogeneity and poor product reconstitution. This article describes various techniques used to control ice nucleation which have been widely used in research and development environments, and demonstrate its use in production manufacturing.

  • A Holistic Strategy To Ensure Container Closure Integrity Of Sterile Injectable Vial Product

    Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity testing (CCIT). However, assuring good CCI of sterile injectable product goes beyond CCI testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This article describes a framework enabling such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.

  • Water Activity And Primary Packaging Selection For Oral Solid Dosage Products

    The draft of the new general chapter USP<922> states that water activity determination can be used to assess the level of protection provided by primary packaging for an oral solid dosage (OSD) product over its entire shelf life. Water activity (Aw) measurements provide unique information, and therefore expand and complement the data collected from USP<670> Auxiliary Packing Components and USP<671> Containers - Performance Testing.

  • Factoring The “What Ifs” Into Supply Forecasting

    Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.




 In this roundtable Q&A, industry experts from AstraZeneca, Takeda, Biogen, and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat “human error” in the workplace.

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