Tag: EXECUTION-CHECKLIST

Implant Coating Machine – Qualification Execution Checklist

Qualification Execution Checklist for Implant Coating Machine Equipment: Implant Coating Machine Subcategory: Implants (Drug-Eluting / Biodegradable) Area: Production DQ/IQ/OQ/PQ: Yes / Yes / Yes / Yes CSV Required: Yes Pre-Start Checks Training completed for all operators SOPs reviewed and approved…

Leak Test Machine (Bottle) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Leak Test Machine (Bottle) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production/QC 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…

Stoppering Machine (Bottle Line) – Qualification Execution Checklist

Qualification Execution Checklist for Stoppering Machine (Bottle Line) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Affairs (RA) approval obtained Calibration/PM…

Implant Cutting Machine – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Implant Cutting Machine Subcategory: Implants (Drug-Eluting / Biodegradable) Area: Production 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 completed Protocol…

Safety Device Assembly Machine – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Safety Device Assembly Machine Subcategory: Prefilled Syringes & Cartridges Area: 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 verified PM status verified…

Nitrogen Purging System (if used) – Qualification Execution Checklist

Nitrogen Purging System Qualification Execution Checklist Equipment: Nitrogen Purging System Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: 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 Regulatory Approval (RA) obtained…

Solvent Addition / Metering Pump – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Solvent Addition / Metering Pump Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified…

CCIT System (Vacuum Decay/HVLD) – Qualification Execution Checklist

Qualification Execution Checklist for CCIT System (Vacuum Decay/HVLD) Nasal & Otic Products (Sterile / Non-Sterile) Area: QC/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…

Aseptic Filling Machine (IV Bottles) – Qualification Execution Checklist

Aseptic Filling Machine Qualification Execution Checklist Equipment: Aseptic Filling Machine (IV Bottles) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Affairs…

Extrusion Machine – Qualification Execution Checklist

Qualification Execution Checklist for Extrusion Machine Equipment: Extrusion Machine Subcategory: Implants (Drug-Eluting / Biodegradable) Area: Production 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…