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Wednesday, July 24, 2024

FDA Warning Letter to a Manufacturer of an Athlete Muscle Maintenance Creme

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On 9 July, the FDA issued a Warning Letter to a Korean manufacturer registered as a manufacturer of over-the-counter drugs. With the Warning...

FDA describes detailed CAPA Procedure in Warning Letter

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An FDA Warning Letter is a formal communication from the US Food and Drug Administration (FDA) notifying a company or individual of regulato...
Friday, July 19, 2024

FDA Warning Letter - Missing incoming Control Tests

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In June 2024, the U.S. FDA issued a Warning Letter to the Portuguese company "Fancystage Unipessoal, LDA" after having inspected i...
Tuesday, July 16, 2024

Fancystage Unipessoal, LDA WL

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In June 2024, the U.S. FDA issued a Warning Letter to the Portuguese company "Fancystage Unipessoal, LDA" after having inspected i...
Wednesday, July 10, 2024

What are skills required to review documents

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The key skills required to effectively review documents are: 1. **Analytical skills** to identify errors, inconsistencies, and gaps in infor...

Difference between review and verification

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The difference between review and verification lies in their purposes and methodologies: - **Review** involves evaluating the suitability, a...
Wednesday, July 3, 2024

Drug shortage Supply Chain Risk Assessment by EMA

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On 18th of June 2024, the EMA has issued templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). Marketing auth...
Tuesday, June 25, 2024

End Product Testing versus Process Validation

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End product testing versus validation? This is a question that is frequently discussed in the GMP environment. The argument is that if the s...

Example for common cause variation in Stastical process control

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Here are some real-world examples of common cause variation in Statistical Process Control (SPC): - Minor fluctuations in raw material prope...

Special cause variation in Stastical Process Control

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Let's consider a manufacturing scenario where Statistical Process Control (SPC) is used to monitor and improve the quality of a producti...