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Aseptic Filling (PFS/Vials) for LAI – DQ Protocol
Document Control Document Number: DQ-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Reviewed By: [Insert Name] Approved By: [Insert Name] Design Qualification Protocol for Aseptic Filling Equipment in Long-Acting Injectables Objective: To ensure that the Aseptic Filling…
Auto Coating Pan (Perforated Pan Coater) – Qualification Execution Checklist
Qualification Execution Checklist Equipment: Auto Coating Pan (Perforated Pan Coater) Subcategory: Solid Dosage Form (OSD) Area: Production/Coating DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Approval (RA) obtained Calibration/PM…
Ophthalmic Sterile Filtration Skid (0.22 µm) – Traceability Matrix (URS ↔ Tests)
URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result URS-001 Confirm the skid meets design specifications for sterile filtration. M DQ-Ref-001 IQ-Ref-001 OQ-Ref-001 PQ-Ref-001 Design Specification Document URS-002 Verify…