Guest Columns

  1. High Absenteeism & The Production Of Medically Necessary Drugs During COVID-19 4/29/2020

    A structured approach to problem solving using quality risk management (QRM) techniques can aid in the development and implementation of action plans and knowledge transfer programs to ensure the production of safe and effective drug products in times of staff shortages related to the COVID-19 pandemic.

  2. Is It Time To Say Goodbye To FMEA Risk Priority Number (RPN) Scores? 4/27/2020

    It may be time to consider eliminating the use of the traditional risk priority number (RPN) score and transitioning to the use of action priority (AP) ratings. AP ratings are much simpler to use, do not require a calculation (eliminating the validation of a spreadsheet), and provides a single simple table reference to determine the appropriate level of action.

  3. Pandemic Prompts Supply Chain Exodus From China — What’s Best For Your Business? 4/27/2020

    Decisions made in panic rarely work out for the best. In lieu of abandoning operations in China completely, consider these alternatives to secure your company’s supply chain.

  4. Ensuring Quality In Ventilator Production Scale-Up For COVID-19 4/24/2020

    Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.

  5. COVID-19’s Impact On Availability Of Drugs And API From India And China 4/23/2020

    COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.

  6. Insulin Under The BPCIA: Opportunities And Obstacles 4/22/2020

    As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.

  7. Decisions In A COVID-19 World: Combat Stress With Quality Risk Management 4/22/2020

    Few of us have ever lived with so much uncertainty and lack of knowledge as we are facing now. This article explains why a structured approach for making risk-based decisions is so important, particularly when we find ourselves in stressful conditions with conflicting needs on many fronts.

  8. What To Expect From The FDA During (And After) COVID-19 4/20/2020

    More than 100 non-COVID-19 trials have been put on hold, and only 14 percent of sites are open for enrollment. This dynamic forces an evaluation of the regulatory impacts our industry faces in the wake of COVID-19 and what to expect in the months ahead.

  9. Applying Aseptic Practices To Protect Yourself From COVID-19 4/20/2020

    During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.

  10. Medtech Data Analysis: Techniques to Create Business-Building Insights 4/20/2020

    Combining industry expertise with sophisticated data science methodologies offers medtechs a more precise and detailed understanding of market dynamics, enabling better business decision-making.