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GMP News

FDA criticises Non-Application of Statistical Process Control (SPC) in Validation

With the introduction of the updated FDA guidance on process validation, a process validation life cycle was introduced in 2011. One of the stages in the cycle is the so-called Continued Process Verification as stage 3, which shows whether the process remains permanently in the validated state. In a recent Warning Letter, the FDA criticised the statistical process control at a drug manufacturer. What was criticised?

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FDA issues Warning Letter to Cell Gene Therapy manufacturer

The US FDA inspected a CGT manufacturer of CAR T cells used in a Phase 2 clinical trial in November 2023 and has now issued a Warning Letter due to GMP violations.

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Large Number of Deficiencies at Indian Manufacturer leads to Warning Letter

The FDA issued a Warning Letter in response to a large number of deficiencies found during an inspection at an Indian manufacturer with aseptic production - and which were not answered with a sufficient catalogue of measures.

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