Tag: QUALIFICATION-CERTIFICATE

Leak Test Machine (CCIT) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Leak Test Machine (CCIT) Subcategory: Prefilled Syringes & Cartridges Area: Production/QC Equipment Identifier: [Equipment Identifier] Qualification Flags Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Qualification…

Lyophilizer (Freeze Dryer) – NDDS – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Lyophilizer (Freeze Dryer) – NDDS Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol References: [Protocol References]…

Cap Tightening Machine – Qualification Certificate Template

Qualification Certificate Equipment: Cap Tightening Machine Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Production/Packaging Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement The…

Vent Filter (Sterile Gas Filter Assembly) – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment: Vent Filter (Sterile Gas Filter Assembly) Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifiers: [Insert Equipment Identifiers] Protocol References: [Insert Protocol…

Serialization System – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Serialization System Subcategory: Suppositories & Implants Area: Packaging Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Protocol References Protocol Reference: [Insert Protocol Reference] Execution Dates Execution Date: [Insert Execution Date] Calibration Status…

Lyophilizer Stoppering System – Qualification Certificate Template

Qualification Certificate Equipment: Lyophilizer Stoppering System Subcategory: Sterile Powders & Lyophilized Products 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 Lyophilizer Stoppering…

VHP Decontamination Unit (if isolator/RABS) – Qualification Certificate Template

Qualification Certificate Equipment: VHP Decontamination Unit 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 Line] Overall Qualification Statement The VHP…

VHP Generator / Decontamination Unit – Qualification Certificate Template

Qualification Certificate Equipment: VHP Generator / Decontamination Unit Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall…