Tag: QUALIFICATION-CERTIFICATE

Ultrafiltration/Diafiltration (UF/DF) Skid – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Ultrafiltration/Diafiltration (UF/DF) Skid Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Insert Equipment Identifier] Protocol References: [Insert Protocol References]…

Vent Filter Assembly – Qualification Certificate Template

Qualification Certificate Equipment: Vent Filter Assembly Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification Statement…

Inline pH Control System – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Inline pH Control System Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifiers: [Equipment Identifiers] Protocol References: [Protocol References] Execution Dates: [Execution…

Suppository Blister Packing Machine – Qualification Certificate Template

Qualification Certificate Equipment: Suppository Blister Packing Machine Subcategory: Suppositories & Implants Area: Packaging Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol…

Die Cutting Machine / Punching Machine – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Die Cutting Machine / Punching Machine Subcategory: Transdermal Patches (TDS) Area: Production Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Requalification Information Requalification Frequency: 12…

Syringe Stoppering Machine – Qualification Certificate Template

Qualification Certificate Equipment: Syringe Stoppering Machine Subcategory: Prefilled Syringes & Cartridges 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 The Syringe Stoppering Machine…

Cap Tightening / Capping Machine – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Cap Tightening / Capping Machine Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Requalification Information Requalification Frequency: 12 Months Equipment Identifiers Equipment ID: [Equipment ID…

Tangential Flow Filtration (TFF) System – Qualification Certificate Template

Qualification Certificate Equipment: Tangential Flow Filtration (TFF) System Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production Equipment Identifier [Equipment Identifier] Protocol References [Protocol References] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification…

Inline Heater / Heat Exchanger – Qualification Certificate Template

Qualification Certificate Equipment: Inline Heater / Heat Exchanger 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 Leak Test Machine – Qualification Certificate Template

Qualification Certificate Equipment: Suppository Leak Test Machine Subcategory: Suppositories & Implants Area: Production/QC Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol References] Execution Dates: [Execution Dates] Calibration Status: [Calibration…