Installation Qualification (IQ)

Installation Qualification (IQ)

1. Purpose To establish a documented procedure to verify that the equipment/system has been properly installed according to manufacturer’s specifications, approved drawings, and regulatory requirements. 2. Scope This SOP applies to all new equipment, instruments,...
Operational Qualification (OQ)

Operational Qualification (OQ)

1. Purpose To describe the procedure for performing and documenting Operational Qualification (OQ) of equipment, instruments, and systems to ensure they operate according to defined specifications and intended performance. 2. Scope This procedure applies to all...
Performance Qualification (PQ)

Performance Qualification (PQ)

1. Purpose To verify and document that the equipment/system performs consistently and reliably under actual production conditions as per predefined specifications and acceptance criteria. 2. Scope This PQ is applicable to [Equipment/System Name] used in...

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