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04 Steps to Investigate Out of Specification (OOS) Result

GMPSOP

04 Steps to Investigate Out of Specification (OOS) Result Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST What is out of specification (OOS) result? What is the difference between OOS and OOT?

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Line clearance procedure and reconciliation in GMP

GMPSOP

Line clearance is the first step in a process, and it is to be done before a line opening. The final step in the sequence is line cleaning, which ensures no raw material, components, or processing records are left behind on the line to avoid mix-ups with the next lot. Unless specific GMP controls are in place (e.g.,