Guest Columns

  1. New EMA Requirements On Nitrosamines: What ALL Pharma Needs To Know

    The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

  2. Will Authorized Biologics Disrupt The Market For Biosimilars?

    Many of the doomsday scenario predictions for biosimilar competition if authorized biologics were to enter the space prematurely assume mainstream development and adoption of authorized biologics by innovator companies in the current market and do not take into consideration the outcomes seen over the past 18 years with authorized small molecule generics.

  3. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project

    In the interest of saving time and getting projects underway as quickly as possible, teams often rely on ad hoc resource allocation and a naively hopeful attitude about who is qualified and capable of bringing the plan to life.

  4. Achieving Integrated Quality Through A Continued Process Verification Program

    Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

  5. Understanding The FDA’s KASA Framework

    The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed. 

  6. The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

  7. Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

  8. Are Good Manufacturing Practices No Longer Good Enough?

    Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?

  9. Can Regulatory And Pharmacopeial Compliance Practices Establish Quality?

    The stated mandate of regulatory authorities (e.g. the FDA) and pharmacopeias (e.g. USP) is to establish and monitor safety, efficacy, and quality of manufactured drug products. This article examines the role of those authorities on quality during production processes.

  10. FDA FY2018 Human Tissue And Cell Therapy Observations And Trends

    This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.