Tag: QUALIFICATION-CERTIFICATE

Sterility Test Isolator / System (if NDDS sterile) – Qualification Certificate Template

Qualification Certificate Equipment: Sterility Test Isolator / System Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: Microbiology Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification…

Viscometer / Rheometer – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Viscometer / Rheometer Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Schedule Requalification Frequency: 12 Months Next Due Date: [Next Due Date Placeholder]…

Osmometer (for parenteral NDDS) – Qualification Certificate Template

Qualification Certificate Equipment: Osmometer Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement The Osmometer has been…

TEM / SEM (as GMP-supporting analytics) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: TEM / SEM Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution…

Nano Tracking Analysis (NTA) System – Qualification Certificate Template

Qualification Certificate Equipment: Nano Tracking Analysis (NTA) System Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement…

Laser Diffraction Particle Size Analyzer – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Laser Diffraction Particle Size Analyzer Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: 12 Months Equipment Identifiers Equipment ID: [Equipment…

Zeta Potential Analyzer – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Zeta Potential Analyzer Equipment Identifier: [Equipment Identifier] Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Protocol References Protocol Reference: [Protocol Reference] Execution Dates…

Dynamic Light Scattering (DLS) Analyzer – Qualification Certificate Template

Qualification Certificate Equipment: Dynamic Light Scattering (DLS) Analyzer Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: QC/R&D Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Equipment Identifiers Equipment ID: [Equipment ID Placeholder] Serial Number: [Serial Number Placeholder] Protocol…