Contributing Editors

41. SOP Remediation: When Reinventing The Wheel Is The Best Approach 11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

42. What Can We Learn From Compounding Pharmacies Producing Small Parenteral Batches? 11/11/2019

    Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?

43. 4 Tips For Successful Collaboration With Your EU Qualified Person 11/8/2019

    Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.

44. Debunking The Top 3 Myths About Quality By Design (QbD) 11/8/2019

    Pharmaceutical QbD and quality risk management principles have become mainstays, but prevalent myths stymie adoption of the concepts. Dismantling those myths enables more companies to capitalize on the benefits of QbD.

45. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project 11/4/2019

    Teams often rely on ad hoc resource allocation and a naively hopeful attitude about the qualifications and capabilities of project team members. These tips can help you avoid such mistakes and improve the chances of your project's success.

46. Achieving Integrated Quality Through A Continued Process Verification Program 11/1/2019

    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. 

47. Understanding The FDA’s KASA Framework 10/30/2019

    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. 

48. The EU Qualified Person (QP) Demystified 10/29/2019

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons may be perceived as a challenge to overcome, because their role and responsibilities are not fully understood.

49. Are Good Manufacturing Practices No Longer Good Enough? 10/28/2019

    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?

50. Can Regulatory And Pharmacopeial Compliance Practices Establish Quality? 10/25/2019

    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.