Contributing Editors
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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Your Local Affiliates Want More From Your Global Regulatory Information Management
11/9/2023
Achieving regulatory excellence depends on a combination of process optimization, effective global systems, high data quality, and better local affiliate collaboration. This article shares key takeaways from new survey results from local offices/affiliates representing 94 countries.
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Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges
11/7/2023
Enteric gel capsules ensure medications are released in the small intestine rather than the stomach, enhancing drug efficacy while minimizing gastrointestinal side effects, and making them a preferred choice for patients. This article examines new market research insights.
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Strategies For Today’s Top Quality & Regulatory Outsourcing Challenges
11/6/2023
Recently, Outsourced Pharma hosted and moderated a Live! event on today's pressing quality and regulatory outsourcing challenges. Outsourced Pharma Chief Editor Louis Garguilo moderated and was joined by Karla Knower, Paradigm Biopharmaceuticals; Christine Feaster, Quality Executive Partners; Bikash Chatterjee, Pharmatech Associates; and Erin O'Brien, Biogen. This article shares the highlights from that panel discussion.
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Human Performance Theories And SOPs: Human Error Prevention In Manufacturing
11/3/2023
Standard operating procedures (SOPs) are often viewed as mere documents to be followed, rather than as dynamic tools. Drawing on human performance theories, this article explores how to create, review, and train on SOPs, as well as how manufacturing and quality teams can collaborate to improve oversight, all with human error prevention in mind.
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FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance
11/2/2023
As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.
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1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next
10/30/2023
The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
10/27/2023
This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.
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The 6 Types of Bio/Pharmaceutical Consultants
10/26/2023
In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants,” but, in fact, there are different types of consulting services. Determining which will serve you best is an important decision before you seek support.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
10/25/2023
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.