GUEST COLUMNISTS

• Identifying, Documenting, & Auditing Processes For Quality Management

  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.

• Put Your Continued Process Verification (CPV) Data To Work

  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.

• Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS

  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?

• Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?

  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.

• Working With Two Consultants On One QMS Overhaul: What Could Go Wrong?

  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. 

• Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics

  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.

• Navigating The FDA’s Emergency Use Authorization Process

  The FDA has been authorized to grant Emergency Use Authorizations for any medical countermeasure that facilitates the diagnosis, prevention, or treatment of SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. Here’s a detailed look at the ramifications and the details.

• Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards

  To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.