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Wednesday, September 25, 2024

Host Cell Proteins - FDA seeks Comments on Immunogenicity Assessment

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Additional substantive information I. Background The FDA uses the term ‘peptide’ in this notice to refer to alpha-amino acid polymers consis...

FDA Issues Warning Letter for Repeated CGMP Violations and Quality Control Failures

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The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated 03 September 2024 to a Canadian over-the-counter (OTC) product man...
Sunday, September 22, 2024

FDA Observation Not using Statistical Process Control (SPC) in Validation

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With the introduction of the updated FDA guidance on process validation, a process validation life cycle was introduced in 2011. One of the ...
Saturday, September 7, 2024

Impact of the US BioShield Act on the Pharmaceutical Business

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The BioShield Act of 2004 significantly influenced the pharmaceutical industry, particularly in the development and production of medical co...

Biosimilars: A Game-Changer in Healthcare

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Introduction Biosimilars, often referred to as biological generics, are a relatively new addition to the pharmaceutical landscape. They offe...
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...