Featured Pharma Online Editorial

1. Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance 9/16/2020

   This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

2. Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs 9/10/2020

   On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."

3. Dos And Don’ts Of Virtual Factory Acceptance Testing In Life Sciences 9/3/2020

   Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.

4. Making FMEA More Robust With HACCP 8/27/2020

   Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

5. A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future 8/14/2020

   Part 1 of this two-part series discussed the history and underlying concepts of process validation (PV), which is required for dealing with the increasingly sophisticated pharmaceutical manufacturing processes necessary for realizing advanced medical therapies. This article describes how PV concepts can be evolved so the industry can better develop, manufacture, and launch the next generations of biopharmaceutical products.

6. A Functional History Of Process Validation, Part 1 – A Weak Foundation 8/7/2020

   This article is the first of a two-part series that describes the origins of process validation to explain the underlying concepts necessary to control the advanced bioprocess manufacturing technologies required to make the next generations of biopharmaceutical therapies.

7. Critical Thinking In Root Cause Investigations: Asking The Right Questions 7/27/2020

   As we write or review a root cause investigation, it is up to each of us to challenge the information we are given, and ensure it stands up to a critical analysis.

8. 5 Operational Priorities For Pharmas In The Wake Of COVID-19 7/20/2020

   Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!

9. Canaries In A Coal Mine: Can Data Integrity Thwart A Deepfake Threat? 7/15/2020

   If you think deepfake security risks are purely science fiction, think again. Not only does the technology exist and the content is readily available to facilitate such activities, but incentives to carry them out are multiplied in the current economic, social, and political environment.

10. System Risk Structures: A New Framework For Avoiding Disaster 7/13/2020

    Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.