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Capsule Polisher – Qualification Execution Checklist
Qualification Execution Checklist Equipment: Capsule Polisher Subcategory: Solid Dosage Form (OSD) Area: Production/Capsules DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes Pre-start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Affairs (RA) approved Calibration/PM Status Verification Calibration status verified Preventive Maintenance (PM)…
Prefilled Syringe Filling Machine – 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 ID 1] The machine must fill sterile drug into syringes with a specified volume. [H/M/L] [DQ Test Ref 1]…
Sigma Mixer / Kneader – Validation Summary Report (VSR) Template
Validation Summary Report for Sigma Mixer / Kneader Summary This Validation Summary Report (VSR) outlines the validation activities conducted for the Sigma Mixer / Kneader used in the production of Solid Dosage Forms (OSD). The equipment has undergone Design Qualification…