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Inline Sifter (Transfer Line) – 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 Ensure the Inline Sifter operates within specified flow rate limits. H DQ-001 IQ-001 OQ-001 PQ-001 Flow Rate Test Record…
Air Classifier Mill – IQ Protocol
Document Control Document Number: IQ-ACM-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared by: [Insert Name] Approved by: [Insert Name] Installation Qualification Protocol for Air Classifier Mill Objective: To verify that the Air Classifier Mill is installed…
RMG (Rapid Mixer Granulator) – Validation Summary Report (VSR) Template
Validation Summary Report (VSR) Equipment Information Equipment: RMG (Rapid Mixer Granulator) Subcategory: Solid Dosage Form (OSD) Area: Production/Granulation DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes Acceptance Criteria Reference: URS Annex11 Key Critical Parameters: Impeller/chopper speed, time, torque, PLC alarms Requalification Frequency: 24 Months Summary…