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Wednesday, February 26, 2025

Vendor CoA based approval and FDA 483

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Insufficient monitoring was carried out to ensure that the system was functioning properly and was suitable for production. FDA requirements...
Thursday, February 20, 2025

API Testing is also relevant for the FDA - Warning letter to Indian Manufacturer

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Access Letter Here The system was poorly designed, e.g. with ‘blind spots’ and lack of continuous circulation, increasing the risk of biofil...
Sunday, February 16, 2025

European Shortages Monitoring Platform (ESMP) goes live

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The European Medicines Agency EMA announced that the European Shortages Monitoring Platform (ESMP) started with the full scope of functional...
Wednesday, February 5, 2025

ANVISA recognises CEPs

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At the beginning of December, a news in the EDQM website newsroom informed that the Brazilian health authority ANVISA (Agência Nacional de V...
Monday, February 3, 2025

Elemental Impurities: Harmonized chapter finalized

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In late November 2024, it was reported on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) that ...
Saturday, January 25, 2025

FDA 483s due to Deficiencies in the Stability Program: Evaluation of Fiscal Year 2024

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Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. Spreadsheets summarizing the areas of regulation...

How to keep Analytical Systems Current and Compliant

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 25 November 2024, Technology Networks published a new article titled "The Museum of Analytical Antiquities," authored by Dr. Bob ...

Pilot Report on the Electronic Product Information (ePI)

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Experience gained from creation of Electronic Product Information (ePI) during a pilot has recently been published in form of a report. The ...
Monday, January 20, 2025

Constant reminders in Pharmaceutical Quality System

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Subscribe here for Regular Updates Article written using AI technology  What is constant reminder A **constant reminder** refers to somethin...

Two new PICS Documents on Remote Assessments published

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Subscribe for Regular Updates Summary   PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments...