Contributing Editors

1. Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance 6/3/2020

   The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

2. 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.

3. 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.

4. DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand? 5/27/2020

   As the requirements for serialization and track & trace become more challenging to implement as we approach 2023, blockchain, by providing data integrity throughout the supply chain, becomes a more attractive solution to reducing the probability of errors occurring.

5. Identifying, Documenting, & Auditing Processes For Quality Management 5/25/2020

   Process results that are predictable and consistent can be achieved more effectively and efficiently when the activities are considered, managed, and understood as interconnected processes that function as a system.

6. 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.

7. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

   The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

8. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

   This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

9. Working With Two Consultants On One QMS Overhaul: What Could Go Wrong? 5/18/2020

   Some companies in the life sciences mistakenly assume that if they hire multiple consulting firms to establish, manage, or overhaul a quality management system, it will inevitably result in an automatic licensure of their new blockbuster product at a low service cost. This article will discuss just such a scenario. 

10. Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics 5/15/2020

    In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application.