Production Featured Articles

1. Knowledge Management — Opportunities & Challenges For Legacy Drug Products 6/1/2020

   This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.

2. 2 (Major) Impediments To Faster Biopharma Product Development 5/29/2020

   As pharma products have become more complicated, companies have become bogged down in accomplishing their mission of launching new products because of complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to patients.

3. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

   Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.

4. Should You List All Manufacturing Facilities In Your Drug Substance Application? Understanding The Supply Chain 5/1/2020

   In Part 1 of this two-part article, we will review the significance of listing facilities in a drug application — namely, how it connects the dots in the supply chain from a raw material manufacturer to the distributor, manufacturer, packager, wholesaler, pharmacy, and finally, the patient, helping to effectively manage supply chain integrity.

5. 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.

6. 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.

7. Continuous Or Batch: Deciding On The Best Solution For Your Oral Solid Dose Product 4/21/2020

   Gaining a better understanding of continuous manufacturing and its fitness for your OSD product could secure more control over the quality and safety of your product and, ultimately, the future of its success.

8. Standardization Is Key To Building A Successful Global Business Strategy 4/15/2020

   Standardized approaches to biomanufacturing can lower costs, improve outcomes and alter the landscape of the global pharmaceutical market.

9. Sponsor Challenges When Outsourcing Sterile Injectables 4/3/2020

   ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

10. EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications 4/3/2020

    While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.