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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...

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 ...