Tag: QUALIFICATION-CERTIFICATE

Ophthalmic Filling Machine (Dropper Bottles) – Qualification Certificate Template

Qualification Certificate Equipment: Ophthalmic Filling Machine (Dropper Bottles) Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement The…

Extrusion System (Liposome Extruder) – Qualification Certificate Template

Qualification Certificate Equipment: Extrusion System (Liposome Extruder) Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification…

LVP/SVP Compounding Vessel (Jacketed SS) – Qualification Certificate Template

Qualification Certificate Equipment: LVP/SVP Compounding Vessel (Jacketed SS) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement [Overall…

Suppository Stripping Machine – Qualification Certificate Template

Qualification Certificate Equipment: Suppository Stripping Machine Subcategory: Suppositories & Implants Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement [Overall Qualification Statement] Approvals [Approvals]…

Crystallizer – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Crystallizer Subcategory: API Manufacturing (Chemical Synthesis & Purification) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier Placeholder] Protocol Reference: [Protocol Reference Placeholder] Execution Date: [Execution…

Drying Oven / Drying Tunnel – Qualification Certificate Template

Qualification Certificate Equipment: Drying Oven / Drying Tunnel Subcategory: Transdermal Patches (TDS) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement [Overall Qualification Statement]…

Sterile Holding Tank – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Sterile Holding Tank Subcategory: Prefilled Syringes & Cartridges Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Dates: [Execution Dates] Calibration…

High Pressure Homogenizer / Microfluidizer – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: High Pressure Homogenizer / Microfluidizer Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production Equipment Identifier: [Equipment Identifier] Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification…

Bag Washing / Blow-off Station (if used) – Qualification Certificate Template

Qualification Certificate Equipment: Bag Washing / Blow-off Station Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Equipment Identifier [Equipment Identifier] Protocol References [Protocol References] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement The…

Cooling Tunnel / Cooling Conveyor – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Cooling Tunnel / Cooling Conveyor Subcategory: Suppositories & Implants Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: 12 Months Qualification Protocol References Protocol Reference: [Insert Protocol Reference…