Editorial
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FDA Issues Second DSCSA Warning Letter — What Does This Mean?
8/16/2023
In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.
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CGMP Requirements For Automated Facility Monitoring Systems
8/15/2023
To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.
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Balanced Sourcing Of Custom Media/Buffer Formulations: The Case For Outsourcing
8/10/2023
Nothing is risk-free; now more than ever, all sourcing options have pros and cons that we need to assess to find the best fit. In this first article of a two-part series, we share three compelling reasons to consider outsourcing, along with key considerations for each.
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Financial Leadership Of Strategic Procurement: 4 Foundational Steps
8/2/2023
Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.
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Agile Software Development In Bio/Pharma & Medical Devices, Part 3
7/25/2023
Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.
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6 Ways To Achieve Manufacturing Audit And Inspection Readiness
7/19/2023
Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.
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Will You Sink, Survive, Or Thrive In This Biotech Market Correction?
7/18/2023
Over the past 18 months, biotech has undergone a major transformation, down from the “sugar high” of the biotech bull market and steady flow of capital in the early pandemic years. Arda Ural or Ernst & Young provides key tips for your biotech to survive and thrive during the current market correction until investment in the sector cycles back to more prosperous times.
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Agile Software Development In Bio/Pharma & Medical Devices, Part 2
7/11/2023
Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.
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The Cancer Drug Shortage: When Quality Fails
7/7/2023
Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.
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Key Considerations In Selecting A Robotic Solution For Endotoxin Testing
7/6/2023
The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.