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Friday, November 22, 2024

Pest Activity, Water Leaks, and Misuse of QC Laboratory in U.S. Drug Manufacturing Facility

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On 29 October 2024, the U.S. Food and Drug Administration (FDA) has published a Warning Letter dated 21 October 2024. The document goes back...
Tuesday, November 5, 2024

FDA announces Experiential Learning Site Visit Program

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The U.S. Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharmaceutical Quality (OPQ) Experiential Lear...
Tuesday, October 29, 2024

Root Cause Analysis: What can be found in FDA Warning Letters?

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corrective action and preventive action (CAPA) according to your procedure until after FDA cited your firm. Bell International Laboratories,...
Sunday, October 20, 2024

USP Chapter 621 Chromatography Intent to Revise

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The USP has issued a Notice of Intent to Revise General Chapter <621> Chromatography. Based on stakeholder feedback, updates will be m...
Saturday, October 19, 2024

Lab Data Integrity issues by US FDA

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The significant violations of CGMP regulations for finished products, which are mentioned in the Warning Letter, are listed as follows: ...
Thursday, October 10, 2024

Management circumvents Quality Department in Deviation Classification - FDA Warning Letter

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From 6 February to 15 March 2024, the FDA inspected the pharmaceutical manufacturing facility of Wittman Pharma, Inc. in Brooksville and fou...

Equipment Qualification and Process Validation by US FDA

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In a recent Warning Letter, the FDA has criticised inadequate equipment qualification and deficiencies in process validation. What does the ...

Does Purified Water have to be tested for Endotoxins?

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When planning new purified water (PW) systems, the question arises as part of the risk analysis or later, when drawing up the qualification ...
Friday, October 4, 2024

Swissmedic introduced it's own GMDP Database

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Swiss medic took new step towards its own database to post GMP/CDP certificate  The Swiss health authority Swissmedic launched the SwissGMDP...
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...