Tag: EXECUTION-CHECKLIST

Microneedle Mold Filling / Casting System – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Microneedle Mold Filling / Casting System Subcategory: NDDS – Transdermal Microneedles / Advanced Patches Area: R&D/Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status…

Vision System (Code/Label Verification) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Vision System (Code/Label Verification) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Packaging/Inspection DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified Preventive…

Sterilization System (EO/Gamma/E-beam) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Sterilization System (EO/Gamma/E-beam) Subcategory: NDDS – Drug-Eluting Stents / Coated Devices Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status…

Coding/Printing Machine (Inkjet/Laser) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Coding/Printing Machine (Inkjet/Laser) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Packaging/Primary DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration completed PM status verified Protocol Readiness and…

Device Inspection System (Vision/Microscopy) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Device Inspection System (Vision/Microscopy) Subcategory: NDDS – Drug-Eluting Stents / Coated Devices Area: QC/R&D DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM…

Labeling Machine (Bag/Bottle) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Labeling Machine (Bag/Bottle) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Packaging/Primary DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status…

Drying Oven for Coated Devices – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Drying Oven for Coated Devices Subcategory: NDDS – Drug-Eluting Stents / Coated Devices Area: R&D/Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status…

HVAC System – Qualification Execution Checklist

Qualification Execution Checklist Equipment: HVAC System Subcategory: Suppositories & Implants Area: System DQ/IQ/OQ/PQ Flags: Critical/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM status verified Protocol Readiness and Approvals…

Stent Coating Machine (Spray/Dip) – Qualification Execution Checklist

Qualification Execution Checklist for Stent Coating Machine Equipment: Stent Coating Machine (Spray/Dip) Subcategory: NDDS – Drug-Eluting Stents / Coated Devices Area: R&D/Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs reviewed and approved User Requirements Specification (URS) approved…

SIP System (Tanks/Lines) – Qualification Execution Checklist

Qualification Execution Checklist for SIP System (Tanks/Lines) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production/Sterilization DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified Preventive…