Production Featured Articles
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Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning
8/17/2023
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
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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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Optimizing Drug Discovery And Development Collaborations
8/15/2023
As demand for more precise, tailored CRO services grows, so does the emphasis drug developers place on their partners’ flexibility, agility, and enthusiasm for collaboration.
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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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Outsourcing: Biomanufacturers May Need Consultants More Than Ever
7/27/2023
When it comes to outsourcing drug development and manufacturing, are consultants important? Explore the role of consultants and industry trends that influence their relationships with organizations.
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An Independent Expert’s Guide To Picking Nanoparticle Manufacturing Equipment
7/26/2023
Until recently, nanoparticle manufacturers had to change equipment between preclinical, clinical, and commercial phases. Advances in technology offer more flexibility allowing manufacturers to turn up the dial on the same machines — from early development all the way to commercialization.
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Overcoming Melt Processing Challenges For Polymer-Based Drug Delivery Systems
7/21/2023
Discover how a biodegradable polymer platform which can be easily applied with hot melt processing enables processing at a relatively low temperature, preserving the potency of temperature sensitive APIs.
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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.