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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...
Saturday, January 18, 2025

Batch Uniformity and Drug Product Integrity / Advanced Manufacturing Technologies US FDA

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In early January 2025, the U.S. Food and Drug Administration (FDA) announced the availability of two new documents. Considerations for Compl...

Is Cloud Computing Open or Closed System according to 21 CFR Part 11?

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The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also organizational advantages speak for the ...

EDQM publishes new FAQ on System Suitability Test (SST)

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The EDQM has announced the addition of a new FAQ to its existing series, addressing the system suitability test (selectivity) in chromatogra...

CMDh/EMA: Update of Appendix 1 for Nitrosamines

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Latest update on 08.01.2025 The nitrosamine Q&A document 'Questions and answers for marketing authorisation holders/applicants on th...
Wednesday, January 8, 2025

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