Tag: VALIDATION-SOP

Automated Visual Inspection (AVI) System – Equipment Validation SOP

Standard Operating Procedure for Automated Visual Inspection System Validation Purpose: This SOP outlines the validation process for the Automated Visual Inspection (AVI) System used in NDDS Packaging and Integrity, ensuring compliance with regulatory requirements and maintaining product quality. Scope: This…

Sterility Test Isolator / System (if NDDS sterile) – Equipment Validation SOP

Standard Operating Procedure for the Validation of Sterility Test Isolator/System Purpose: This SOP outlines the validation process for the Sterility Test Isolator/System used in microbiological applications to ensure compliance with regulatory standards and product integrity. Scope: This procedure applies to…

Viscometer / Rheometer – Equipment Validation SOP

Equipment Validation SOP for Viscometer/Rheometer in NDDS Purpose: This SOP outlines the validation process for the Viscometer/Rheometer used in NDDS, ensuring compliance with regulatory standards and maintaining product quality. Scope: This procedure applies to the validation of the Viscometer/Rheometer utilized…

Osmometer (for parenteral NDDS) – Equipment Validation SOP

Standard Operating Procedure for the Validation of Osmometer in NDDS Analytics Purpose: This SOP outlines the validation process for the Osmometer used in routine osmolality testing for parenteral NDDS, ensuring compliance with regulatory requirements and product quality. Scope: This procedure…

TEM / SEM (as GMP-supporting analytics) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of TEM/SEM in NDDS Analytics Purpose: This SOP outlines the validation process for the Transmission Electron Microscope (TEM) and Scanning Electron Microscope (SEM) used for Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)…

Nano Tracking Analysis (NTA) System – Equipment Validation SOP

Standard Operating Procedure for the Validation of Nano Tracking Analysis (NTA) System Purpose: This SOP outlines the validation process for the Nano Tracking Analysis (NTA) System, ensuring compliance with regulatory requirements and maintaining product quality. Scope: This procedure applies to…

Laser Diffraction Particle Size Analyzer – Equipment Validation SOP

Standard Operating Procedure for the Validation of Laser Diffraction Particle Size Analyzer Equipment Validation, NDDS, Critical NDDS Analytics, Laser Diffraction Particle Size Analyzer, QC, R&D Purpose This SOP outlines the procedures for the validation of the Laser Diffraction Particle Size…

Zeta Potential Analyzer – Equipment Validation SOP

Standard Operating Procedure for the Validation of Zeta Potential Analyzer Equipment Validation, NDDS, Critical NDDS Analytics, Zeta Potential Analyzer, QC, R&D Purpose This Standard Operating Procedure (SOP) provides guidelines for the validation of the Zeta Potential Analyzer to ensure compliance…