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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...

A Guide to Statistical Process Control (SPC)

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In today's competitive business landscape, maintaining consistent quality is paramount for success. Statistical Process Control (SPC) is...
Wednesday, June 19, 2024

Sun Pharma's Dadra unit gets USFDA warning letter

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Sun Pharma's Dadra unit had received an Official Action Indicated (OAI) status from the USFDA on April 11 this year. This was after the ...
Monday, June 17, 2024

Warning Letter to Indian Sterile Manufacturer due to egregious GMP Deficiencies 17.06.2024

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The nine-day FDA inspection of an Indian pharmaceutical manufacturer had already taken place in October 2023. Due to the numerous and, as th...
Friday, June 14, 2024

CHMP confirms Suspension of Marketing Authorizations with Studies of Synapse Labs

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The re-examination by the Committee for Medicinal Products for Human Use (CHMP) confirms the suspension of marketing authorizations with bio...
Tuesday, June 11, 2024

Checklist for Implementation of GDP Principles - Part 8: Self-Inspections

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According to  Chapter 8 (Self-Inspections)  of the EU GDP Guidelines  (Guidelines of 5 November 2013 on Good Distribution Practice of medici...
Monday, June 10, 2024

EU adopts Supply Chain Law - Implications for pharmaceutical Companies

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On 24th of May 2024, the EU member states adopted the European Supply Chain Law which requires companies of a certain size to monitor and pr...

What is the history of current good manufacturing practices

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The history of Current Good Manufacturing Practices (cGMP) dates back to the early 20th century in the United States. The first major event ...