Expert Insights On Fill/Finish

71. Considerations For Sterility Test Methods When Working With CDMOs 1/13/2023

    Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.

72. CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance 12/21/2022

    While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

73. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

74. 4 Key Takeaways For Combination Products As We Move Into 2023 12/13/2022

    The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.

75. Help! The Particle Count Is Overwhelming Us! 12/12/2022

    Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.  

76. Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview 12/1/2022

    This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

77. A Methodology To Support Particle Investigations In Biopharma Products 11/22/2022

    Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

78. Pharma Process Validation: Initial Conclusions Are Often Deceptive 9/26/2022

    As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.

79. A Practical Guide To Navigate The EU's Revised GMP Annex 1 9/9/2022

    The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.

80. The Environmental Impact Of Biopharma Continuous Manufacturing: Part II 8/22/2022

    Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.