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Monday, August 26, 2024

Switzerland to implement Measures to combat Shortages of Medicines

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The Swiss Federal Council has discussed measures to improve the supply of medicines in Switzerland and is endeavouring to implement a number...
Saturday, August 24, 2024

Quality Risks Associated with Uncalibrated Pressure Gauges

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If a pressure gauge is not calibrated within its scheduled date, it can lead to several quality risks:  * Inaccurate Measurements: An uncali...

Assessing Specificity in Potentiometric Assays

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Specificity in a potentiometric assay refers to the ability of the method to measure the analyte of interest without interference from other...
Wednesday, August 21, 2024

Warning Letter to US Company due to Lack of Product and Process Control

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On 05 August, the FDA issued a warning letter to the US company LS Promotions Inc. in Hicksville. The warning letter is the result of a revi...

EMA/CMDh: Q&A Document Nitrosamines revised

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In July 2024, the  nitrosamine Q&A document  "Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorization ho...
Wednesday, August 14, 2024

TGA introduces shorter Surveillance Inspections

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From 1 July 2024, the Australian TGA will introduce, at least temporarily,  new regulations for GMP inspections  of domestic and foreign man...
Sunday, August 11, 2024

Is it possible to remove a Biofilm in pharmaceutical Water Systems?

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advantage is that the increased temperature also reaches areas that are difficult to access, such as branch pipes, if the duration of the th...
Sunday, August 4, 2024

Change Control and (Re)Validation - The FDA Perspective

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The topic of revalidation is rarely mentioned in the regulations. Ongoing/continued process verification has replaced regular revalidation (...

Containment: What is the Difference between OEB and OEL

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In manufacturing, where potentially hazardous substances are handled, concepts such as Occupational Exposure Bands (OEB) and Occupational Ex...
Friday, August 2, 2024

FDA Warning Letter on Data Integrity Issues Dominican company Laboratorio Magnachem

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On June 18, 2024, the FDA issued a Warning Letter to the Dominican company Laboratorio Magnachem International regarding CGMP violations. Th...