Featured Pharma Online Editorial

71. 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.

72. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

73. The Discriminative Power Of Dissolution Methods In The US & Europe 2/22/2023

    The discriminatory power is a factor that may be game changing for dissolution testing of immediate release tablets in quality control or R&D. Let's examine the American perspectives (FDA and USP) and the European perspective (EMA).

74. 4 Focus Areas To Modernize Your Cleaning Validation Strategy 1/30/2023

    The traditional outlook on cleaning validation might look inexpensive and safe, but it can lead to serious problems in the long run. To modernize your cleaning validation strategy for 2023, here are four areas to focus on.

75. What's Behind The ASTM E3263 Standard Revision? 1/17/2023

    ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.

76. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

77. 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.

78. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

    Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

79. 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.

80. FDA Releases Guidance On Drug Products Containing Nanomaterials 11/18/2022

    In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.