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News
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Warning Letters
February 20, 2025
FDA Issues Warning Letter to ABR Laboratory LLC Over Quality Control Failures
FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance...
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Articles
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QA
February 18, 2025
6 Steps on How to Perform Root Cause Analysis (RCA)
Learn the 6 key steps to perform Root Cause Analysis (RCA) in pharmaceutical GMP. Prevent recurrence, improve compliance, and enhance...
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Articles
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Manufacturing
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Microbiology
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QA
February 11, 2025
Contamination, Cross-Contamination, and Mix-Ups in Pharmaceutical Manufacturing
Differentiate contamination, cross-contamination, and mix-ups in pharma manufacturing. Discover their causes, impacts, and prevention strategies to ensure GMP compliance....
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Articles
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Maintenance
January 28, 2025
Types of Airlocks Used in the Pharmaceutical Industry
Explore types of airlocks in pharma: Cascade, Bubble, Sink. Learn how they ensure contamination control, cleanroom integrity, and GMP compliance....
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Articles
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QC
January 21, 2025
Karl Fischer Titration: The Gold Standard for Water Content Analysis
Karl Fischer titration essentials - the gold standard for precise water content determination....
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News
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Regulatory Updates
January 5, 2025
FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110
FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
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News
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Warning Letters
December 29, 2024
FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning
FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...
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Articles
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Manufacturing
December 17, 2024
Flow Properties of Powders and Granules in Pharma Industry
Explore the flow properties of powders and granules in pharma manufacturing. Learn key factors, metrics, and methods ensuring product consistency...
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Articles
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QA
December 4, 2024
How to Write a Compliant SOP in the Pharma Industry?
Learn how to write SOPs in the pharmaceutical industry. A step-by-step guide on structure, best practices, and ensuring GMP compliance...
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News
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Regulatory Updates
December 1, 2024
FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
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