Featured Pharma Online Editorial
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Upskilling Your Quality Team For The AI Revolution In Pharma 4.0
3/21/2025
While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.
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What FDA Draft Guidance Tells Us About In-Process Control Strategies
2/28/2025
The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.
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Strengthening Shop-Floor QA From The Ground Up
2/24/2025
Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.
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Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis
2/18/2025
Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
2/3/2025
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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Addressing Blind Spots In Assuring Therapeutic Equivalence
1/14/2025
The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.
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Deploy AI To Become A cGMP 'Special Agent' With A License To Care
1/7/2025
Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."
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Count On Data Integrity Auditors Making These 10 Requests
12/9/2024
Every audit, however unique, requires confirmation that effective data integrity governance exists, supported by strong SOPs, proper validation, and regulatory adherence.
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A Guide To QbD For Small Molecule Drug Product Manufacturing Excellence
11/13/2024
Leveraging the quality by design (QbD) approach to achieve manufacturing excellence is game-changing. This article shares QbD principles, benefits, and successful case studies.
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Computer Systems Validation Pitfalls, Part 1: Methodology Violations
10/9/2024
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.