EXECUTION-CHECKLIST – Pharma Validation

Sterility Test Isolator / System (if NDDS sterile) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Sterility Test Isolator / System (if NDDS sterile) Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: Microbiology DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed SOPs approved URS approved Regulatory Affairs approved Calibration/PM Status…

Viscometer / Rheometer – Qualification Execution Checklist

Qualification Execution Checklist for Viscometer / Rheometer Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) 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 status verified…

Osmometer (for parenteral NDDS) – Qualification Execution Checklist

Qualification Execution Checklist for Osmometer Equipment: Osmometer (for parenteral NDDS) Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC 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…

In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus) Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D 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 records reviewed PM…

Encapsulation Efficiency Measurement Setup (HPLC/UPLC + separation) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Encapsulation Efficiency Measurement Setup (HPLC/UPLC + Separation) Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D 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…

TEM / SEM (as GMP-supporting analytics) – Qualification Execution Checklist

Qualification Execution Checklist for TEM / SEM Equipment: TEM / SEM Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D 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 status verified…

Nano Tracking Analysis (NTA) System – Qualification Execution Checklist

Qualification Execution Checklist for Nano Tracking Analysis (NTA) System Equipment Details Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D 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 status verified…

Laser Diffraction Particle Size Analyzer – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Laser Diffraction Particle Size Analyzer Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D 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 status verified PM status…

Zeta Potential Analyzer – Qualification Execution Checklist

Qualification Execution Checklist for Zeta Potential Analyzer NDDS – Critical NDDS Analytics (CQA/CPP) Pre-start Training completed Standard Operating Procedures (SOPs) approved User Requirements Specification (URS) approved Regulatory Affairs (RA) approval obtained Calibration/PM Status Verification Calibration status verified Preventive Maintenance (PM)…

Dynamic Light Scattering (DLS) Analyzer – Qualification Execution Checklist

Qualification Execution Checklist for Dynamic Light Scattering (DLS) Analyzer Equipment Details Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed for all relevant personnel Standard Operating Procedures (SOPs) approved User Requirements…