Which step would NOT be included in the verification that an advanced therapy medicinal product manufacturing equipment adheres to user specifications and GMP requirements?

Prepare for the RAPS RAC-Drugs Certification with flashcards and multiple choice questions. Each question includes hints and explanations. Be exam ready!

The correct answer, which indicates that Process Qualification (PQ) would not be included in the verification of whether advanced therapy medicinal product manufacturing equipment adheres to user specifications and GMP requirements, aligns with the roles of each qualification step in the context of Good Manufacturing Practice (GMP).

Installation Qualification (IQ) primarily ensures that the equipment is installed correctly and according to the manufacturer's specifications. This step is essential to confirm that the setup is as intended before any operations begin.

Operation Qualification (OQ) assesses whether the equipment operates as intended across its specified operating ranges. This step evaluates the equipment's functionality and ensures that it can perform its designed tasks.

Performance Verification (PV) is a step that involves testing the equipment in its operational environment to confirm that it consistently produces outputs that align with user specifications.

In contrast, Process Qualification (PQ) is more focused on the validation of the manufacturing process and its ability to consistently produce quality products, rather than specifically verifying the equipment itself. While PQ is critical in establishing that a process works as intended, it does not pertain to the direct verification of equipment compliance with user specifications and GMP, making it the correct choice for the step that would not be included in that particular verification context.

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