Featured Pharma Online Editorial
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Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points
4/13/2020
With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.
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Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”
3/16/2020
During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?
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The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study
3/11/2020
To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology.
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Packaging Good Manufacturing Practices (GMPs) For Medicinal Products
1/6/2020
Has your primary packaging materials supplier established, implemented, and maintained an adequate quality management system? The requirements of ISO 9001 may not provide the necessary levels of GMPs and rigor to ensure the packaging materials are adequate for their intended use.
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Pulling Double Duty: Packaging Considerations For Combination Products
1/2/2020
Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.
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ISO 10993: Considerations For Drug Delivery Devices
12/4/2019
A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.
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Improving Biopharma Packaging Line Efficiency Through Overall Equipment Effectiveness (OEE)
11/20/2019
While the boipharmaceutical industry has benefited from high margins and low competition for decades, operational efficiency remains a low priority item for packaging departments in life sciences..
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Intro To Prefilled Syringe Selection: Staked-In Needles
10/15/2019
This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts.
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An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
9/30/2019
This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.
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Examining FDA’s New Patient Labeling Draft Guidance
9/9/2019
The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.