Featured Bioprocessing Editorial

61. Developing An Automated GxP Workflow Integrated With 21 CFR Part 11 1/22/2021

    The electronic records and electronic signatures (ERES) regulations, 21 CFR Part 11 and EU Annex 11, provide life sciences companies an opportunity to reap the organizational benefits of paperless record-keeping systems. 

62. First In Line: FDA Vs. EMA Biopharma Approval Times 1/20/2021

    The majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy, but should they? This article reviews data from more than 200 new therapeutics approved by the FDA over the past five years to determine if there really is a difference in approval timelines between the FDA and EMA.

63. 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter 1/18/2021

    In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.

64. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

    One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

65. 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers 1/13/2021

    Without changes in the market for generics, profits will likely continue to erode in the sector as products become more commoditized. Generic drug makers do have some recourse to help improve margins. We’ve outlined three approaches that are not mutually exclusive for generic drug manufacturers’ future success. Each has its own set of investment requirements, risks, and growth potential.

     

66. An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report 1/11/2021

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019. 

67. Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues 1/8/2021

    The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

68. 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement 1/6/2021

    This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

69. Facility Design & Construction Tips For Up-Start Biotech Companies 1/4/2021

    Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

70. Seeing Double: Using Digital Twins To Improve Pharma Processes 12/30/2020

    The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.