Also Check:
RABS / Isolator (if used) – IQ Protocol
Document Control Number: IQ-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Prepared by: [Your Name] Approved by: [Approver’s Name] Installation Qualification for RABS/Isolator in Ophthalmic Production Objective: To verify that the RABS/Isolator system is installed correctly and operates according…
Capping Machine (ROPP/Screw) – Qualification Execution Checklist
Qualification Execution Checklist for Capping Machine (ROPP/Screw) Equipment: Capping Machine Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Approval (RA)…
Otic Drop Filling Machine – OQ Protocol
Document Number: OQ-EDFM-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Operational Qualification Protocol for Otic Drop Filling Machine Objective The objective of this Operational Qualification (OQ) protocol is to ensure that the Otic Drop Filling Machine operates according to…