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GMP News

Reduced Testing a Matter of GMP or Specification?

In a Q&A document, the EMA clearly defines and distinguishes that reduced incoming testing of starting materials is a GMP issue; in contrast to 'skip testing'.

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Quality Unit (QU) in the Focus of a Warning Letter: Oversight Failures and FDA Expectations

A recent FDA Warning Letter exposes gaps in equipment suitability, facility upkeep, and quality oversight and shows how an empowered QU can prevent these failures before they reach the inspection room.

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GDPA Participated as an Observer in the EMA GMDP-IWG Interested Parties Meeting

On 11 June 2026, the “Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group Interested Parties Meeting” took place online. Alfred Hunt attended on behalf of GDPA as an observer, supporting the association in staying closely connected to regulatory discussions and tracking upcoming GDP developments early.

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