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Tablet Compression Machine (Single Rotary) – 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 Machine must operate within specified speed range. M DQ-001 IQ-001 OQ-001 PQ-001 Speed Test Report URS-002 Compression force must…
Flake Crusher (Post-Roller Compaction) – Validation Summary Report (VSR) Template
Validation Summary Report (VSR) Equipment: Flake Crusher (Post-Roller Compaction) Subcategory: Solid Dosage Form (OSD) Area: Production/Dry Granulation DQ/IQ/OQ/PQ Flags: Yes / Yes / Yes / Yes Acceptance Criteria Reference: URS Key Critical Parameters: Speed screen output PSD Requalification Frequency: 24…
Vibro Sifter – Qualification Execution Checklist
Qualification Execution Checklist for Vibro Sifter Equipment Information Equipment: Vibro Sifter Subcategory: Solid Dosage Form (OSD) Area: Production/Sieving DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes Pre-Start Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified Preventive Maintenance (PM)…