Featured Pharma Online Editorial

  1. Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning 8/17/2023

    FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.

  2. FDA Issues Second DSCSA Warning Letter — What Does This Mean? 8/16/2023

    In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.

  3. CGMP Requirements For Automated Facility Monitoring Systems 8/15/2023

    To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

  4. Agile Software Development In Bio/Pharma & Medical Devices, Part 3 7/25/2023

    Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.

  5. 6 Ways To Achieve Manufacturing Audit And Inspection Readiness 7/19/2023

    Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.

  6. FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity 7/18/2023

    The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

  7. Avoid These 29 API Manufacturing Deficiencies 7/17/2023

    Most API manufacturers are constantly improving their processes, but mistakes still happen. This list of deficiencies from the GMP Compliance Adviser explains what to watch out for.

  8. Navigating The Pros And Cons In Annex 1's PUPSIT Requirements 7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.

  9. Agile Software Development In Bio/Pharma & Medical Devices, Part 2 7/11/2023

    Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.

  10. Patenting Functionally Claimed Biological Compounds After Amgen V. Sanofi 7/10/2023

    Snell & Wilmer attorneys discuss the recent SCOTUS decision to uphold the Federal Circuit's holding that Amgen’s patent claims for functionally claimed antibodies were invalid for failing to meet the enablement requirement. The attorneys share what this means for the industry going forward.