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Encapsulation Coater (Wurster/Bottom Spray) – 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 The equipment must maintain a consistent spray rate for optimal coating. H DQ-001 IQ-001 OQ-001 PQ-001 Spray Rate Calibration…
Patch Pouch Packaging Machine – PQ Protocol
Performance Qualification Protocol for Transdermal Patch Pouch Packaging Document Number: PQ-TP-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Objective The objective of this Performance Qualification (PQ) protocol is to validate the Patch Pouch Packaging Machine to ensure…
Split Butterfly Valve (SBV) Transfer System – Qualification Execution Checklist
Qualification Execution Checklist Equipment: Split Butterfly Valve (SBV) Transfer System Subcategory: Solid Dosage Form (OSD) Area: Production/Containment DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status verified Protocol Readiness and…