Featured Pharma Online Editorial
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5 Recommendations To Maximize CSV/CSA Outcomes
7/17/2024
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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Correct But Misleading: AI Hallucinations In Complex Decision-Making
7/11/2024
Managing risks associated with AI hallucinations requires "explainability," a process that identifies patterns or behaviors in AI models that are inconsistent with training data or logical expectations. Regulators are mandating transparency in AI models used for drug testing and development.
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System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
6/26/2024
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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How Generative AI Could Change Pharmaceutical Manufacturing
6/14/2024
Despite the hype, pharma has been slow to integrate artificial intelligence. Other industries have shown how it adds value by simplifying tedious tasks.
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Defining And Overcoming Batch Release Deviations
5/31/2024
Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.
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Sorting Through Winners And Losers Of New Technology In Pharma
5/30/2024
Innovation and improvement are often used synonymously, but sometimes innovation hinders more than helps. Here’s a cold-eyed look at recent blockbuster tech advances.
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EMA Updates Guidance On Inhalation And Nasal Product Quality
5/29/2024
The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.
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Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview
5/2/2024
This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.